Allogeneic Bone Marrow Mesenchymal Stromal Cells (BM-MSCs) and Allogeneic Umbilical Cord Mesenchymal Stromal Cells (UC-MSC)

Ottawa Hospital Research Institute (2020-05-15)

CIRCA-19 (Control # 238608)

Cellular Immunotherapy for COVID-19 acute respiratory distress syndrome (ARDS) (CIRCA) the Vanguard Study

NCT04400032

Phase 1

Completed

Start Date: 2020, May 15

Study completion date: 2021, April 22

(Dose escalating and safety trial)

Experimental 1: Mesenchymal Stromal Cells (MSCs) 25 million cells/unit dose (cumulative dose: 75 million MSCs) IV

Experimental 2: MSCs 50 million cells/unit dose (cumulative dose: 150 million MSCs) IV

Experimental 3: MSCs up to 90 million cells/unit dose (cumulative dose: up to 270 million MSCs) IV

Adult, COVID-19, on invasive mechanical ventilation <48h, ARDS

9 participants

Progressed to a Phase 2 RCT

Allogeneic umbilical cord mesenchymal stromal cells (UC-MSCs)

Ottawa Hospital Research Institute (2021-04-13)

CIRCA-19 RCT (Control #250736)

Cellular immune-therapy for COVID-19 ARDS (CIRCA-19) randomized clinical trial

NCT04865107

Phase 2

Recruiting

Start Date: 2021, April 27

Estimated study completion date: 2022, April

Experimental: UC-MSCs 3 doses daily up to 90 million cells/dose IV (max cumulative dose of 270 million calls)

Placebo comparator: PlasmaLyte A and 5% Human Albumin 3 doses daily up to 90 million cells/dose IV (max cumulative dose of 270 million calls)

18+, SARS-CoV-2 positive, ARDS needing ventilation

54 participants

No results posted

Apabetalone (RVX000222)

Resverlogix Corp (2021-04-06)

RVX222-CS-023 (Control #250480)

An open-label study to assess the safety and effect on clinical course and key biomarkers of oral apabetalone in hospitalized subjects with COVID-19 infection in addition to standard of care (SOC)

NCT04894266

Phase 2

Not yet recruiting

Start date: 2022, January 14

Estimated completion date: 2022, September 22

Experimental: Apabetalone 100mg BID + standard of care

Comparator: standard of care

18+, SARS-CoV-2 positive, hospitalized

100 participants

Not yet posted

Apheresis frozen plasma from recovered COVID-19 patients (Convalescent Plasma)

C17 Council (2020-05-04)

CONCOR-Kids (Control # 238830)

CONCOR-KIDS: A randomized, multicentered, open-label Phase 2 clinical trial of the safety and efficacy of human Coronavirus-immune convalescent plasma for the treatment of COVID-19 disease in hospitalized children

NCT04377568

Phase 2

Withdrawn (no enrollment)

Start date:2020, October 7

Withdrawal date: 2021, April 23

Experimental: Convalescent plasma 10mL/kg up to 500mL IV infusion (one dose)

No Intervention: Clinical standard of care

Children (<19 years), COVID-19, hospitalized

0 participants

Withdrawn (no enrollment)

Apheresis frozen plasma from recovered COVID-19 patients (Convalescent Plasma)

Hamilton Health Sciences (2020-04-16)

GRAAL-2020-01 (Control #238201)

A randomized, open-label trial, of convalescent plasma for hospitalized adults with acute COVID-19 respiratory illness (CONCOR-1)

NCT04348656

Phase 3

Terminated

Start date: 2020, May 14

Study termination date: 2021, June 16

Experimental: ABO compatible convalescent apheresis plasma 500mL (1 unit of 500mL or 2 units of 250mL)

No Intervention: Clinical standard of care

16 years +, COVID-19, hospitalized, receiving supplemental oxygen

940 participants

Terminated (Study was terminated after the planned interim analysis as the pre-defined futility threshold was met)

AT-527 (RO7496998)

Hoffman La Roche Limited (2021-05-20)

WV43042 (Control #252494)

A phase II randomized double-blind, placebo controlled study to evaluate the antiviral activity safety, pharmacokinetics, and efficacy of RO7496998 (AT-527) in non-hospitalized adult patients with mild or moderate COVID-19

NCT04709835

Phase 2

Completed

Start date: 2021, February 3

Study completion date: 2021, October 13

Experimental: AT-527 550mg BID

Placebo comparator: placebo

18+, SARS-CoV-2 positive, outpatient

104 participants

Did not meet the primary endpoint in the overall population of patients with mild or moderate COVID-19, who were mostly low-risk with mild symptoms In high-risk patients with underlying health conditions, a reduction of viral load was observed compared to placebo

Baricitinib, Remdesivir, Tocilizumab

Dr. Lisa Barrett (2020-04-14)

SAIL-004 (control # 237708)

Assessment of Investigational Medications adjunct to Clinical Standard of Care for Treatment of Moderate to Severe Coronavirus Disease (COVID-19) (in Hospitalized Patients)

NCT04321993

Phase 2

Recruiting

Start Date: 2020, April 17

Estimated study completion date: 2023 March

Experimental: (moderate and severe, not critical disease) Baricitinib (janus kinase inhibitor) 4mg po daily for 14 days or until hospital discharge

Experimental: (moderate and severe, not critical disease) Remdesivir (antiviral) 200mg IV over one hour (loading dose) on Day 1 followed by 100mg IV daily over one hour on Days 2-5 with possibility of extending up to 10 days)

Experimental: (moderate and severe, not critical disease) Remdesivir (antiviral) 200mg IV over one hour (loading dose) on Day 1 followed by 100mg IV daily over one hour on Days 2-5 with possibility of extending up to 10 days) + Baricitinib (janus kinase inhibitor) 4mg po daily for 14 days or until hospital discharge

Experimental: (severe, critical disease) Tocilizumab (interleukin 6 inhibitor) 8mg/kg total bodyweight up to 800mg max, IV over one hour

No Intervention: Clinical standard of care

Adult (18+), hospitalized, moderate to severe COVID-19

800 participants

No results posted as of yet

Bemnifosbuvir (BEM; AT-527)

Atea Pharmaceuticals Inc. (2022-12-06)

AT-03A-017 / control # 269964 (Authorized under the COVID-19 Regulations)

A Phase 3 randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of bemnifosbuvir in high risk outpatients with COVID-19

NCT05614349

Phase 3

Recruiting

Start Date: 2022, November 25

Estimated study completion date: 2024, January

Experimental: Bemnifosbuvir (BEM) PO BID for 5 days

EPlacebo Comparator: Placebo tablets PO BID q 5 days

18 + years, SARS-CoV-2 positive, high risk of disease progression

1500 participants

No results posted as of yet

Bovine lipid extract surfactant suspension (BLES)

St Joseph’s Health Centre London (2020-05-05)

LESSCOVID (Control #238851)

Exogenous surfactant administration for patients with COVID-19 (London’s exogenous surfactant study for COVID19 (LESSCOVID)

NCT04375735

Phase 1/2

Completed

Start date: 2020, July 1 (estimated)

Study completion date: 2021, October 6

Experimental: Bovine Lipid Extract Surfactant 2ml/kg via suction catheter through the ET tube daily for up to 3 doses, for as long as patient is on the ventilator

No Intervention: Clinical standard of care

Adult, COVID-19, Acute respiratory failure requiring intubation 

20 participants

Sponsor reported that:

Due to the small sample size, no significant clinical benefit could be attributed to surfactant treatment.

Safety established as no significant adverse events attributed to the surfactant treatment.

No peer reviewed data/published results.

BRII-196/BRII-198/AZD7442

National Institute of Allergy and Infectious Diseases (NIAID) (2021-04-08)

ACTIV-2/A5401 (Control #250685) Authorized under the clinical trials interim order

Adaptive platform treatment trial for outpatients with COVID-19 (Adapt Out COVID)

NCT04518410

Phase 2/3

Active, not recruiting

Study start date: 2020, August 19

Estimated study completion date: 2023, June 22r

Experimental: BRII-196/BRII-198 1000mg/1000mg combo one dose IV infusion

Experimental: AZD7442 300mg one dose IV infusion

Placebo comparator: 0.9% sodium chloride solution one dose IV infusion

Experimental: SNG001 1.3mL solution inhaled once daily for 14 days

Placebo comparator: Trisodium citrate dihydrate, di-sodium hydrogen-phosphate, sodium dihydrogen-phosphate dihydrate, racemic methionine (DL-methionine) and water 1.3mL solution inhaled once daily for 14 days

Experimental: AZD8895 300mg IM and AZD1061 300mg IM one dose of each sequentially

Placebo comparator: 0.9% sodium chloride solution IM two injections sequentially

Experimental: Camostat 200mg PO every 6 hours for 7 days

Placebo comparator: Placebo tablets PO every 6 hours for 7 days

Experimental: C135-LS 400mg SC and C144-SL 400mg SC one dose 4 injections

Placebo comparator: Placebo SC 4 injections one dose

18+, SARS-CoV-2 positive, outpatient

8797 participants

No results posted

Cadesartan/ Valsartan/ Ramipril/ Perindopril/ Irbesartan/ Losartan/ Enalapril/ Captopril

Ottawa Heart Institute Research Corporation (2020-10-16)

CTO-3212 (Control #244591) filed under the IO

Evaluation of the potential benefit of reninangiotensin system inhibitors (RASI, ACEI/ARB) in high risk patients with COVID-19

Phase 3

Recruiting

Start date: 2021, January 27

Estimated study completion date: 2024, December

No intervention: Clinical standard of care

Experimental: ACE inhibitor (dose based on local practice)

Experimental: ARB (dose based on local practice)

65+, COVID-19, high risk comorbidity

1155 participants

No results posted

Camostat Mesilate

McGill University Health Centre (2020-07-02)

MUHC_CAMOSTAT MESILATE (Control #240313)

The impact of Camostat Mesilate on COVID-19 Infection: A randomized controlled Phase II Clinical Trial

Phase 2

Camostat mesilate/Candesartan

Vancouver General Hospital (2021-03-22)

CAM-001 (Control #247212)

Efficacy of camostat mesylate in reducing severity of COVID-19

Cannabidiol (CARDIOLRX)

Cardiol Therapeutics Inc. (2021-07-16)

CARDIOL 100-03 (Control #254314)

Study to evaluate the efficacy and safety of CARDIOLRX in patients with COVID-19 and cardiovascular disease or risk factors, a double-blind, placebo-controlled trial (LANCER)

NCT04615949

Phase 2/3

Terminated

Start date: April 30, 2021

Termination date: 2022, November 30

Experimental: Cannabidiol 2.5-7.5mg/kg of body weight p.o. b.i.d

Placebo comparator: placebo 2.5-7.5mg/kg of body weight p.o. b.i.d

Adult (18+), SARS-CoV-2 positive, not in ICU

90 participants

Terminated (The changing nature of COVID-19 including a more vaccinated population, increasing natural population immunity, milder variants and other related factors has meant that it is no longer realistic to recruit the patients in a reasonable time frame.)

Carbon Dioxide and Perflubron (S-1226)

SolAeroMed Inc. (2020-12-31)

SAMI-05-1-01 (Control #247617)

A randomized, open-label, controlled Phase II study to evaluate the safety, tolerability and efficacy of S-1226 in hospitalized subjects with moderate severity COVID-19

NCT04738136

Phase 2

Suspended (sponsors decision)

Start date: February 15, 2021 (estimated)

Estimated study completion date: December 31, 2021

Experimental: Standard of care + S-1226 inhaled at either 4%, 8%, or 12% CO2 twice daily for up to 5 days

No intervention: Clinical standard of care

Moderate COVID-19, hospitalized, experiencing bronchiolitis/pneumonia

30 participants

Not yet posted

Carbon Dioxide and Perflubron (S-1226)

SolAeroMed Inc. (2021-06-21)

SAMI-06-1-01 (Control #253521)

A randomized, placebo-controlled phase II study to evaluate the safety, tolerability, and efficacy of S-1226 in post-COVID-19 subjects with persistent respiratory symptoms

NCT04949386

Phase 2

Not yet recruiting

Start date: September 2021 (estimated)

Estimated study completion date: January 2022

Experimental: Perfluorooctylbromide (PFOB) gas/aerosol/vapor in a 8% carbon dioxide medical gas mixture, inhaled for 3-4minutes, twice daily for 7 days

Placebo comparator: Saline 3mL and medical grade air inhaled for 3-4 minutes

Adults (18-80 years), evidence of new or persistent respiratory symptoms at least 4 weeks after the onset of acute COVID-19 infection

48 participants

Not yet posted

Chimeric interferon alpha (Novaferon)

Genova Inc. (2020-12-11)

JH-COR-003 (Control #246575) Authorized under the clinical trials interim order with terms and conditions

NOVATION-1: A randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of aerosolized novaferon + SOC vs. placebo + SOC in hospitalized adult patients with moderate to severe COVID-19

NCT04669015

Phase 3

Recruiting

Start date: 2021, June 10

Estimated primary completion date: 2022, August

Experimental: Novaferon 20ug BID (inhaled) for 10 days + clinical standard of care

Placebo comparator: Formulated vehicle BID (inhaled) for 10 days + clinical standard of care

18+, SARS-CoV-2 positive, COVID-19 symptomatic, hospitalized

914 participants

Not yet posted

Cholecalciferol (Vitamin D₃)

Centre Hospitalier Universitaire Sainte-Justine (2020-09-16)

PROTECT (Control #243196)

Prevention of COVID-19 with Oral Vitamin D Supplemental Therapy in Essential Healthcare Teams

NCT04483635

Phase 3

Terminated

Start Date: 2021, February 8

Termination date: 2021, May 28

Experimental: Vitamin D3 10 tablets containing 10 000 IU PO once, followed by 10 000 IU once every week for 16 weeks

Placebo Comparator: Placebo tablet 10 PO once, followed by 1 placebo tablet once a week for 16 weeks

Adult age 18-70, Health Care workers working in settings with high-risk of contact with COVID-19 cases

34 participants

Terminated (A premature discontinuation was recommended by the Data Safety Monitoring Board and agreed upon by the principal investigator, because the significantly lower recruitment than planned, in the context of mass vaccination of the target population.)

Ciclesonide

Research Institute of McGill University Health Centre (2020-05-23)

Mild-CONTAIN 2021-6639 (Control #239123)

Mild-CONTAIN CiclesOnide cliNical TriAl CovId-19 treatmeNt

NCT04435795

Phase 2/3

Terminated

Start date: 2020, September 14

Study termination date: 2021, July 8

Experimental: Ciclesonide 50mcg intranasal BID and ciclesonide 600mcg inhaled BID for 14 days

Placebo comparator: Normal saline intranasal BID and Placebo 3 puff MDI inhaled BID

Adult, COVID-19, symptomatic

215 participants

Terminated (Could not meet target enrolment)

Colchicine

Montreal Heart Institute (2020-03-20)

COLCORONA MHIPS-2020-001 (Control #237317)

Colchicine coronavirus SARS-COV2 trial (COLCORONA)

NCT04322682

Phase 3

Completed

Start Date:2020, March 23

Study completion date: 2022, October 1

Experimental: Colchicine 0.5mg PO BID for 3 days, then once daily for the last 27 days.

Placebo Comparator: Placebo PO BID for 3 days, then once daily for the last 27 days.

Adults 40+, COVID-19 (within 24hrs), outpatient setting, must possess high-risk criteria (70 years or more of age, obesity (BMI ≥ 30 kg/m2), diabetes mellitus, uncontrolled hypertension (systolic blood pressure ≥150 mm Hg), known respiratory disease, known heart failure, known coronary disease, fever of ≥38.4°C within the last 48 hours, dyspnea at the time of presentation, bicytopenia, pancytopenia, or the combination of high neutrophil count and low lymphocyte count)

4488 participants (actual)

Did not meet primary or secondary endpoints

Tardif JC, et al. Colchicine for community-treated patients with COVID-19 (COLCORONA): a phase 3, randomised, double-blinded, adaptive, placebo-controlled, multicentre trial. Lancet Respir Med. 2021 May 27:S2213-2600(21)00222-8. doi: 10.1016/S2213-2600(21)00222-8. Epub ahead of print. PMID: 34051877; PMCID: PMC8159193.

Colchicine/acetylsalicylic acid/rivaroxaban/interferon beta-1b

Hamilton Health Sciences (2020-04-18)

PHRI.ACT.COVID19 (Control #238157)

Anti-coronavirus therapies to prevent progression of COVID-19 (ACT), a randomized trial

NCT04324463

Phase 3

Recruiting

Start Date: 2020, April 21

Estimated study completion date: 2022, April 30

Outpatients

Experimental: Colchicine 0.6mg PO BID for 3 days, then 0.6mg once daily for 25days

Experimental: Aspirin (ASA) 75-100mg PO once daily for 28days

No intervention: Clinical standard of care

Inpatients

Experimental: Colchicine 1.2mg PO followed by 0.6mg PO 2 hours later, then 0.6mg PO BID for 28 days

Experimental: Interferon Beta 0.25mg PO by subcutaneous injection on days 1,3,5, & 7

Experimental: Aspirin (ASA) 75-100mg once daily for 28days

Experimental: Rivaroxaban 2.5mg PO BID for 28 days

No intervention: Clinical standard of care

Outpatient trial

Adult, COVID-19 within 7 days of diagnosis or clinically worsening, high risk (age>70, male, obesity (BMI >30), chronic cardiovascular, respiratory or renal disease, active cancer, diabetes)

Inpatient trial

Adult, COVID-19, hospitalized (within 24hours or clinically worsening)

4000 participants

Inpatient Colchine, rivaroxaban, and aspirin arms: Among patients hospitalised with COVID-19, neither colchicine nor the combination of rivaroxaban and aspirin prevent disease progression or death. Increased risk of gastrointestinal ADRs and bleeding.

Other study arms ongoing

CPI-006

Corvus Pharmaceuticals Inc. (2021-03-01)

CPI-006-003 (Control #249442) Authorized under the clinical trials interim order

Phase 3, randomized, placebo controlled, double-blind, multicenter, stratified study of CPI-006 plus standard of care in mild to moderately symptomatic hospitalized COVID-19 patients

NCT04734873

Phase 3

Terminated

Start date: 2021, February 25

Termination date: 2021, August 16

Experimental: CPI-006 2mg/kg or 1mg/kg

Placebo comparator: Placebo

18+, hospitalized for COVID-19

46 participants

Terminated (Sponsor decision. Not related to safety issues.)

Dalcetrapid

Dalcor Pharma UK Ltd (2020-11-26)

DAL-401 (Control #246298) Authorized under Clinical Trial Interim Order

A double-blind, placebo-controlled phase 2A proof-of-concept trial of Dalcetrapid in patients with confirmed mild to moderate COVID-19

NCT04676867

Phase 2

Completed

Start date: 2021, January 11

Study completion date: 2021, May 17

Experimental: Dalcetrapid 900mg PO for 10 days, or 1800mg PO for 10 days, or 3600mg PO for 10 days

Placebo comparator: Placebo PO for 10 days

18+, SARS-CoV-2 positive, COVID-19 symptomatic, outpatient

208 participants

No benefit

Dapagliflozin

Saint Luke’s Hospital of Kansas City (2020-07-04)

D1690C00081 (Control #240352) Authorized under clinical trials interim order

An international, multicenter, randomized, double-blind, placebo-controlled, Phase III study evaluating the efficacy and safety of dapaglifozin in respiratory failure in patients with COVID-19 (Dapagliflozin in respiratory failure in patients with COVID-19 (DARE-19))

NCT04350593

Phase 3

Completed

Start date: 2020, April 22

Study completion date: 2021, June 11

Experimental: Dapagliflozin 10mg daily

Placebo Comparator: Placebo 10mg daily

Adult, mild-moderate COVID-19 (cannot be ventilated), hospitalized (no more than 4 days prior to screening), high risk (medical history of hypertension, T2DM, atherosclerotic cardiovascular disease, heart failure, or CKD stage 3 or 4 (eGFR 25-60mL/min.1,72m²))

1250 participants (actual)

In patients with cardiometabolic risk factors who were hospitalised with COVID-19, treatment with dapagliflozin did not result in a statistically significant risk reduction in organ dysfunction or death, or improvement in clinical recovery, but was well tolerated

Dapsone

Research Institute of McGill University Health Centre (2020-08-20)

PDC01 (Control #242430)

A randomized, placebo-controlled, multicenter study to assess the safety & efficacy of dapsone on the treatment of COVID-19 positive patients (DAP-CORONA)

NCT04935476

Phase 3

Recruiting

Start date: 2021, November 22

Estimated study completion date: 2022, July 31

Experimental: Dapsone 85mg PO BID for 21 days

Placebo comparator: Placebo PO BID for 21 days

Adult 40+, COVID-19 with symptom onset within the last 4 days, outpatient, high risk (at least 1 comorbidity) 

3000 participants

No results yet posted

Dexamethasone

University Health Network (2023-02-07)

OZUHN-004 / control# 271810

Platform Of Randomized Adaptive Clinical Trial in Critical Illness (PRACTICAL) Randomized Control Trial

EB05

Edesa Biotech Research Incorporated (2020-06-12)

EB05-04-2020 (Control #239462) CTA issued under CT interim order

A randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of EB05 + standard of care (SOC) vs. placebo + SOC in adult hospitalized patients with moderate to severe COVID-19 pneumonia

NCT04401475

Phase 2/3

Recruiting

Start Date: 2020, November 25

Estimated study completion date: 2021, April

Experimental: EB05 15mg/kg IV (single infusion) + clinical standard of care

Placebo comparator: Placebo IV (single infusion) + clinical standard of care

Adult, COVID-19, Hospitalized, requiring supplemental oxygen 

396 participants

No results yet posted

EMVODODSTAT (PTC299)

PTC Therapeutics Inc. (2022-02-02))

PTC299-VIR-015-COV19 (Control # 260607)

Evaluation of the efficacy and safety of PTC299 in hospitalized subjects with covid-19 (FITE19)

NCT04439071

Phase 2/3

Terminated

Start date: 2020, July 9

Termination date: 2022, July 20

Experimental: PTC299 200mg PO BID on Days 1 to 7, then 50mg PO QD on Days 8 to 14 + standard of care (SOC)

Placebo comparator: matching placebo + SOC

18+, hospitalized, SARS-CoV-2 positive

189 participants

Terminated (Sponsor decision)

Favipiravir

Appili Therapeutics Inc. (2020-05-18)

CONTROL-COVID-Favipiravir-1 (Control #239133)

Control of COVID-19 outbreak in long term care

NCT04448119

Phase 2

Terminated

Start date: 2020, October 16

Termination date: 2021, October 30

Experimental: (Prophylaxis) Favipiravir 1600mg (8 x 200mg tablets) PO BID on Day 1, followed by 800mg PO BID on Days 2-25

Experimental: (Treatment) Favipiravir 2000mg PO BID on Day1, followed by 1000mg PO BID for 13 days

Placebo comparator: (Prophylaxis) Placebo 8 tablets PO BID on Day 1, followed by 4 tablets PO BID on Days 2-25

Placebo comparator: (Treatment) Placebo 10 tablets PO BID on Day 1, followed by 5 tablets PO BID for 13 days

Adult 65+, long-term care resident, COVID-19 outbreak declared in one nursing unit

67 participants

Terminated (Recruitment challenges)

Favipiravir

Appili Therapeutics Inc. (2020-11-02)

ATI0320 (Control #244962)

Favipiravir for post exposure prophylaxis in SARS-COV2-exposed vulnerable individuals (PEPCO) double-blinded, placebo-controlled, randomized, multinational, phase-3 clinical trial to evaluate the efficacy of favipiravir in preventing the development of COVID-19 when given to asymptomatic SARS-CoV2-negative individuals who had direct exposure to a SARS-CoV2 infected person

Phase 3

Experimental:

Placebo comparator:

Fenretinide (LAU-7B)

Laurent Pharmaceuticals (2020-05-02)

LAU-20-01 (Control #238614)

A double-blind, randomized, placebo-controlled, pilot phase II study of the efficacy and safety of Lau-7B in the treatment of adult hospitalized patients with COVID-19 disease (RESOLUTION)

NCT04417257

Phase 2/3

Recruiting

Start date: 2020, June 29

Estimated study completion date: 2023, April

Experimental: LAU-7b PO QD for up to 14 days

Placebo Comparator: Placebo PO QD for up to 14 days

45+, COVID-19, must have a comorbidity (diabetes, cardiovascular disease (including hypertension), respiratory disease (COPD, asthma, emphysema), smoker with 20-pack year history, Obesity, 70+, elevated troponin, or elevated CRP), hospitalized (or under observation)

508 participants

In the overall moderate-to-critical patient population, LAU-7b did not meet its primary endpoint. However, in the moderate-to-severe COVID-19 patient subgroup LAU-7b + standard of care reduced the risk of death and progressing to mechanical ventilation by Day 60. BUT trial expanded to a Phase 3 trial. Results not posted.

Fluvoxamine

Research Institute of McGill University Health Centre (2020-11-30)

2021-7362 (Control #246471)

Fluvoxamine for early treatment of COVID-19: A randomized placebo controlled trial (STOP COVID 2 Canada)

NCT04668950

Phase 3

Completed

Start date: 2020, December 22

Completion date: 2021, September 28

Experimental: Fluvoxamine 50mg PO once, then 100mg BID (as tolerated) for 15 days

Placebo comparator: Placebo 50mg PO once, then 100mg BID for 15 days

18+, SARS-CoV-2 positive, COVID-19 symptomatic, ambulatory/not hospitalized

683 particpants

Was stopped for futility by a data safety monitoring board after lower than expected case rates and treatment effect were observed

Fondaparinux/ Tinzaparin Sodium (Innohep)/Dalteparin sodium (Fragmin)/Enoxaprin sodium (Lovenox)/Lovenox HP/Heparin (Therapeutic Anticoagulation)

Unity Health Toronto (2020-04-24)

RAPID COVID COAG (Control #238510)

Coagulopathy of COVID-19: A pragmatic randomized controlled trial therapeutic anticoagulation versus standard care as a rapid response to the COVID-19 pandemic (RAPID COVID COAG)

NCT04362085

Phase 3

Completed

Start Date: 2020, May 11

Study completion date: 2021, October 14

Experimental: Therapeutic anticoagulation (LMWH or UFH at clinician’s discretion) administered in hospital until discharged, for 28 days, or death.

No Intervention: Clinical standard of care

Adult, COVID-19, hospitalized, one D-dimer value above ULN (within 72hrs of hospital admission) and either, D-dimer >2times ULN or D-dimer above ULN and oxygen saturation <93%

462 participants

Therapeutic heparin was not significantly associated with a reduction in the primary composite outcome but the odds of death at 28 days was decreased

Furosemide

Kingston Health Science Centre (2010-10-13))

FAST-1 (Control #244310) filed under the IO)

Nebulized furosemide for pulmonary inflammation in intubated patients with COVID-19- A phase 2/3 study

NCT04588792

Phase 2/3

Recruiting

Start date: 2021, April 16

Estimated study completion date: 2023, March 15

Experimental: Furosemide 40mg given by nebulization over 30mins QID for 28days

Placebo comparator: Placebo given by nebulization QID for 28days

Adult (18+), COVID-19, on mechanical ventilation

640 participants

No results posted

GS-5245 (Remdesivir prodrug)

Gilead Sciences Canada Inc. (2022-09-20)

GS-US-611-6273 / control # 267297

A phase 3, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of GS-5245 for the treatment of COVID-19 in participants with high-risk for disease progression

Phase 3

GSK3196165 (Otilimab), monoclonal antibody

GlaxoSmithKline (2020-05-27)

Protocol 214094 (Control #239770)

A randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of otilimab IV in patients with severe COVID-19 related disease

NCT04376684

Phase 2

Completed

Start date: 2020, May 28

Study completion date: 2021, August 16

Experimental: Otilimab IV (single dose) + clinical standard of care

Placebo Comparator: Placebo (0.9% sodium chloride solution) IV (single dose) + clinical standard of care

Adult 18-79 years, COVID-19, hospitalized due to pneumonia, needing oxygen, have elevated markers of systemic inflammation (C-reactive protein > ULN or serum ferritin > ULN)

1156 participants

Did not meet its primary end-point. However, patients 70 years and older in the otilimab + standard of care arm were less likely to experience respiratory failure 28 days after treatment and had reduced mortality up to Day 60.

Hydroxychloroquine

St. Joseph’s Health Care Parkwood site (2020-05-09)

115769 (Control #238857)

Safety and efficacy of post-exposure prophylaxis with hydroxychloroquine (HCQ) for the prevention of Corona Virus Infectious Disease-19 (COVID-19) in high-risk patients/residents in institutions

NCT04397328

Phase 3

Withdrawn

Experimental: Hydroxychloroquine 400mg PO, followed by 400mg in 8 hours, then 200mg BID for 4 days

Placebo Comparator: Matched placebo doses tablets PO

>40 years with one or more high risk comorbidities or >60 years, patient/resident of long-term care or other institute, exposed to a known or suspected COVID-19 case

336 participants

Withdrawn

Hydroxychloroquine

Research Institute of the McGill University Health Centre (2020-03-25)

COVID19 PEP PCT – Canada 2020-6549 (Control #237355)

Post-exposure prophylaxis or preemptive therapy for SARS-Coronavirus-2: A pragmatic randomized clinical trial (COVID19 PEP RCT – Canada)

NCT04308668

Phase 3

Completed

Start Date: 2020, March 17

Study completion date:

2020, May 20

Experimental: Hydroxychloroquine 800mg (4 x 200mg tablets) PO, followed by 600mg 6-8hrs later, then 600mg QD for 4 days 

Placebo Comparator: Placebo 4 tablets PO, followed by 3 tablets 6-8hrs later, then 3 tablets QD for 4 days

Adult, COVID-19 exposure within 4 days, COVID-19 within 4 days, outpatient at time of exposure

1309 participants (Actual)

After high-risk or moderate-risk exposure to COVID-19, hydroxychloroquine did not prevent illness compatible with COVID-19 or confirmed infection when used as a postexposure prophylaxis within 4 days after exposure

Hydroxychloroquine

University Health Network (2020-04-03)

HEROS-1 (Control #237851)

Protecting frontline health care workers from COVID-19 with hydroxychloroquine pre-exposure prophylaxis: A randomized, placebo-controlled multi-site trial in Toronto, Canada

NCT04374942

Phase 3

Terminated

Start Date:2020, April 30

Termination date: 2021, April 29

Experimental: Hydroxychloroquine 400mg QD for 3 months

Placebo Comparator: Placebo QD for 3 months

Adult, health care worker in the emergency department 

13 participants

Terminated (Due to unproven issues associated with hydroxychloroquine use and safety, further complicated by media and political misinformation which in effect rendered all global studies on HCQ to stop enrolling participants.)

Hydroxychloroquine

University of Calgary (2020-04-09)

HOPE ABCOV-01 (Control #237739)

A randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of oral hydroxychloroquine for the treatment of SARS-CoV-2 positive patients for the prevention of severe COVID-19 disease (ALBERTA HOPE COVID-19)

NCT04329611

Phase 3

Terminated

Start Date: 2020, April 13

Termination date: 2020, May 22

Experimental: Hydroxychloroquine 400mg PO BID for 1 day, followed by 200mg PO BID for 4 days

Placebo Comparator: Placebo PO BID for 1 day, followed by PO BID for 4 days

Adult, COVID-19 within 4 days

148 participants (actual)

Terminated (Enrolment was suspended on 22may2020, after Mehra et al (Lancet 2020) then stopped due to lack of Covid19 cases.)

Hydroxychloroquine

Research Institute of the McGill University Health Centre (2020-05-04)

MP-37-2021-6659 (Control #238811)

A multi-centre, randomized, blinded, placebo controlled clinical trial of the safety and effectiveness of hydroxychloroquine for the treatment of COVID-19 in hospitalized children

Hydroxychloroquine

University of Manitoba (2020-05-08)

PREP2020 (Control #238396)

Pre-exposure prophylaxis for SARS-Coronavirus-2: A pragmatic randomized clinical trial

NCT04308668

Phase 3

Completed

Start date:2020, March 17

Study completion date: 2020, May 20

Experimental: Hydroxychloroquine 800mg PO, followed by 600mg in 6-8hours, then 600mg BID for 4 days

Placebo comparator: Matching placebo tablets PO

18+, COVID19 or exposure to a COVID19 case

1309 participants (actual)

After high-risk or moderate-risk exposure to COVID-19, hydroxychloroquine did not prevent illness compatible with COVID-19 or confirmed infection when used as postexposure prophylaxis within 4 days after exposure

Hyperpolarized Xenon-129

St. Joseph’s Healthcare Hamilton (2020-11-05)

FIRH_XE006 (Control #245507)

Lung structure-function in survivors of mild and severe COVID19 infection: 129XE MRI and CT for rapid evaluations and next wave healthcare planning

Hyperpolarized Xenon-129

Robarts Research Institute, Schulich School of Medicine and Dentistry, Western University (2020-11-27)

ROB0050 (Control #246389)

Lung structure-function in survivors of mild and severe COVID19 infection: 129XE MRI and CT for rapid evaluations and next wave healthcare

NCT04584671

Not yet recruiting

Study start date: 2020, December (estimated)

Estimated study completion date: 2024, December

18-80, SARS-CoV-2 positive

200 participants

Not yet posted

Hyperpolarized Xenon-129

The Hospital for Sick Children (2021-04-29)

1000074027 (Control #251634)

Lung structure-function in survivors of mild and severe COVID19 infection: 129XE MRI for rapid evaluation and nextwave healthcare planning (LIVECOVIDFREE)

Icosapent ethyl (Vascepa)

Canadian Medical and Surgical Knowledge Translation Research (2020-05-08)

VASCEPA-COVID-19 CARDIOLINK-9 (Control #239025)

An investigation on the effects of icosapent ethyl (Vascepa) on inflammatory biomarkers in individuals with COVID-19 cardiolink-9

NCT04412018

Phase 2

Completed

Start date: 2020, June 4

Completion date: 2020, December 12

Experimental: Icosapent Ethyl 4g BID for 3 days, then 2g BID for 11 days

No intervention: Clinical standard of care

18-75 years, COVID-19, symptomatic, out-patient

100 participants

Evidence of an early anti-inflammatory effect of icosapent ethyl in a modest sample, including an initial well-tolerated loading dose, in symptomatic outpatients with COVID-19.

Tinzaparin sodium (Innohep)/enoxaparin sodium (Lovenox)/dalteparin sodium (Fragmin)/Heparin Sodium

University of Manitoba (2020-04-29)

OZM-113 (Control #238691)

Therapeutic-dose anti-coagulation for the treatment of hospitalized patients with COVID-19: the antithrombotic therapy to ameliorate complications of COVID19 (ATTACC) trial

NCT04372589

Phase 2/3

Completed

Start Date: 2020, May 20

Study completion date: 2021, May 17

Experimental: LMWHeparin (preferably enoxaparin (1mg/kg subcutaneous (SQ) BID) but can be tinzaparin (175 anti-Xa IU/kg SQ QD) or dalteparin (200IU/kg SQ QD or 100IU/kg SQ BID), 3^rd option is unfractionated heparin (dependant on availability) for 14 days, until hospital discharge, or liberation of oxygen >24hrs)

No intervention: Clinical standard or care (including usual thromboprophylactic dose anticoagulation according to local practice)

Adults, COVID-19, Hospitalized (enrolled in study <72hrs since hospital admission and expected to remain in hospital >72hrs), not receiving mechanical ventilation

1200 participants (actual)

In noncritically ill patients with Covid-19, an initial strategy of therapeutic-dose anticoagulation with heparin increased the probability of survival to hospital discharge with reduced use of cardiovascular or respiratory organ support as compared with usual-care thromboprophylaxis (No benefit in critically ill patients)

Isoflurane, sevoflurane

Sunnybrook Health Sciences Centre (2020-06-10)

2149 (Control #240138) Authorized under Clinical Trials Interim Order

Sedating and volatile anesthetics critically ill COVID-19 patients in ICU: Effects on ventilatory parameters and survival; Multicentre open-label, pragmatic, randomised controlled trial and a parallel prospective (non-randomised) cohort study (SAVE-ICU)

NCT04415060

Phase 3

Recruiting

Start Date: 2020, June 15

Estimated study completion date: 2023, June 15

Experimental: Isoflurane inhalant product (either Isoflurane or Sevoflurane depending on availability) dosage is based on clinical judgement

No intervention: Clinical standard of care (IV sedation)

Adults, COVID-19, mechanically ventilated <48hrs

752 participants

No results posted

Ifenprodil (NP-120)

Algernon Pharmaceuticals (2020-04-29)

AGN120-3 (Control #238605)

A randomized open label Phase 2/3 study of the safety and efficacy of NP-120 (Ifenprodil) for the treatment of confirmed COVID-19 Infected hospitalized patients

NCT04382924

Phase 2/3

Completed

Start Date: 2020, August 5

Completion date: 2021, January 25

Experimental: Ifenprodil (NP-120) 20mg TID

Experimental: Ifenprodil (NP-120) 40mg TID

No Intervention: Clinical standard of care

Adult, COVID-19, hospitalized, requiring oxygen or non-invasive ventilation,

168 participants

No benefit, terminated

Ixekizumab (Taltz)/ Apremilast tablets (Otezla)/ Lanadelumab/ Zilucoplan

Amgen Canada Inc. (2020-08-20)

COV-01 (control #242568) Authorized under the clinical trials interim order

Industry alliance platform trial to assess the efficacy and safety of multiple candidate agents for the treatment of COVID-19 in hospitalized patients

NCT04590586

Phase 3

Completed

Start Date: 2020, November 24

Completion date: 2021, August 3

Experimental: Apremilast PO + standard of care (SOC)

Experimental: Lanadelumab IV + SOC

Experimental: Zilucoplan SC + SOC

Placebo comparator: Matching placebo PO

Adult (18+), COVID-19, Hospitalized

516 participants

Terminated

Lopinavir/ritonavir

Unity Health Toronto (2020-03-21)

CORIPREV-1 (Control #237350)

COVID-19 ring-based prevention trial with lopinavir/ritonavir (CORIPREV-LR)

NCT04321174

Phase 3

Active, not recruiting

Start Date: 2020, April 17

Estimated study completion date: 2022, March 31

Experimental: Lopinavir/ritonavir 400/100mg PO BID for 14 days

No intervention: Clinical standard of care

>6months of age, High-risk close contact with a confirmed COVID-19 case during their symptomatic period (including one day before symptom onset), with the past 1-7days

123 participants

No results posted

Lopinavir/ritonavir, Interferon beta-1a, apo-hydoxyquine, Heparin sodium, Lovenox, Fragmin, Innohep, Aphresis frozen plasma from recovered COVID-19 patients (convalescent plasma), Kineret, Vitamin C

Unity Health Toronto (2020-04-01)

REMAP-CAP X17-0199 (Control #237719)

Randomized, embedded, multifactorial adaptive platform trial for community-acquired pneumonia (REMAP-CAP): Pandemic appendix to the core protocol

NCT02735707

Phase 4

Recruiting

Start Date: 2016, April 11

Estimated study completion date: 2023, December

Experimental: Hydrocortisone 50mg IV q6hrs for up to 7days

No intervention: clinical standard of care but no systemic corticosteroid

Experimental: Hydrocortisone 50mg IV q6hrs (when in septic shock)

Experimental: Ceftriaxone + Macrolide (dose and duration according to local practice guidelines)

Experimental: Moxifloxacin + Levofloxacin (according to local practice guidelines)

Experimental: Piperacillin-tazobactam + Macrolide (according to local practice guidelines)

Experimental: Ceftaroline + Macrolide (according to local practice guidelines)

Experimental: Amoxicillin-clavulanate + Macrolide (according to local practice guidelines)

Experimental: (nested within other antibiotic arms) Macrolide (azithromycin is preferred but clarithromycin or roxithromycin are possible substitutes) for 3 to 5 days

Experimental: (nested within other antibiotic arms) Macrolide (azithromycin is preferred but clarithromycin or roxithromycin are possible substitutes) for 14 days or at hospital discharge

No Intervention: clinical standard of care but no antiviral agent active against influenza

Experimental: Oseltamivir PO BID for 5 days or at hospital discharge

Experimental: Oseltamivir PO BID for 10 days or at hospital discharge  

No intervention: clinical standard of care but no antiviral against SARS-CoV-2

Experimental: Lopinavir/ritonavir 400/100mg PO or 5mL 80/20mg/mL solution suspension via gastric tube q12hrs for 5-14 days (depending on hospital discharge)

Experimental: Hydroxychloroquine 800mg PO q6hrs for two doses then 400mg q6hrs for 12 doses or until hospital discharge

Experimental: Hydroxychloroquine 800mg PO q6hrs for two doses then 400mg q6hrs for 12 doses or until hospital discharge + lopinavir/ritonavir 400/100mg PO or 5mL 80/20mg/mL solution suspension via gastric tube q12hrs for 5-14 days (depending on hospital discharge)

No Intervention: Clinical standard of care but no immune modulating therapy

Experimental: Interferon-Beta1a 10ug IV QD for 6days or until hospital discharge

Experimental: Anakinra (interleukin-1 receptor antagonist) 300mg IV followed by 100mg IV q6hrs

Experimental: Hydrocortisone 100mg IV q6hrs for 7 days

Experimental: Tocilizumab 8mg/kg IV (single dose)

Experimental: Sarilumab 400mg IV (single dose)

No intervention: clinical standard of care but no vitamin C

Experimental: Vitamin C 500mg/kg IV q6hrs for 16 doses

No intervention: clinical standard or care + local standard care thromboprophylaxis for 14 days

Experimental: LMWHeparin or UF Heparin IV (to achieve systemic anticoagulation according to local practice)

No Intervention: Standard care but no simvastatin for up to 28 days while hospitalized

Experimental: Simvastatin 80mg PO QD while hospitalized

No Intervention: standard care but no immunoglobulin during hospitalization

Experimental: ABO convalescent plasma (no more than 2 units)

No intervention: standard of care + invasive mechanical ventilation (according to local practice)

Experimental: Invasive mechanical ventilation (protocolized strategy) 

Adult, ICU admitted within 48hrs of hospitalization, severe community acquired pneumonia (CAP) and/or suspected or proven COVID19, lower respiratory tract infection, radiological evidence of new onset consolidation, requiring ventilation, receiving infusion of vasopressor and/or inotropes

7100 participants

Corticosteroid domain was halted after results were released from another trial. Follow-up ended August 12, 2020. Among patients with severe COVID-19, treatment with a 7-day fixed-dose course of hydrocortisone or shock-dependent dosing of hydrocortisone, compared with no hydrocortisone, resulted in 93% and 80% probabilities of superiority with regard to the odds of improvement in organ support-free days within 21 days. However, the trial was stopped early and no treatment strategy met prespecified criteria for statistical superiority, precluding definitive conclusions.

Results from other arms of the trial have not been posted

Losartan

Providence Health Care Saint Paul’s Hospital (2020-09-28)

ARBS CORONA II (Control # 243532) Authorized under the Interim Order

Host response mediators in coronavirus (COVID-19) infection – Is there a protective effect of losartan on outcomes of coronavirus infection?

NCT04606563

Phase 3

Terminated

Start date: 2020, October 9

Termination date: 2022, April 22

Experimental: Losartan 25mg PO, stepped up to 50mg and then up to 100mg, as tolerated, q24hrs for length of hospital stay (max 3 months)

No intervention: clinical standard of care

Adult (18+), COVID-19, hospitalized

341 participants

Terminated (DSMC recommendation due to futility)

LSALT Peptide

Arch Biopartners Inc. (2020-05-07)

AB002 (Control #238815)

Multi centre, randomized, double-blind, placebo controlled, proof of concept trial of LSALT PEPTIDE as prevention of acute respiratory distress syndrome (ARDS) in patients infected with SARS-CoV-2 (COVID-19)

NCT04402957

Phase 2

Active, not recruiting

Start Date: 2020, July 1

Estimated study completion date: 2021, June 30

Experimental: LSALT peptide 100mL of 5mg IV QD

Placebo Comparator: 0.9% saline solution 100mL IV QD

45-80 years old, moderate to severe COVID-19, hospitalized, APACHE II score <20

60 participants

Company’s press release reports potential benefit and no ADRs. Trial is being expanded. Peer reviewed report not yet available.

MK-4482 (molnupiravir)

Merck Canada Inc. (2020-10-19)

MK-4482-001 (Control #244315) filed under the interim order

A phase 2/3 randomized, placebo controlled, double-blind clinical study to evaluate the efficacy, safety and pharmacokinetics of MK-4482 in hospitalized adults with COVID-19

NCT04575584

Phase 2/3

Terminated

Start Date: 2020, October 19

Study termination date: 2021, August 11

Experimental Part 1: Molnupiravir 200mg PO q12hrs for 5 days

Experimental Part 1: Molnupiravir 400mg PO q12hrs for 5 days

Experimental Part 1: Molnupiravir 800mg PO q12hrs for 5 days

Experimental Part 2: Molnupiravir (dose TBD) PO q12hrs for 5 days

Placebo comparator: Placebo matching tablet PO q12hrs for 5 days

Adult (18+), mild-moderate COVID-19 for under 7 days

304 participants

Terminated (Business reasons)

MK-4482 (molnupiravir)

Merck Canada Inc. (2020-10-19)

MK-4482-002 (Control #244159) filed under the interim order

A phase 2/3 randomized, placebo controlled, double-blind clinical study to evaluate the efficacy, safety and pharmacokinetics of MK-4482 in non-hospitalized adults with COVID-19

NCT04575597

Phase 2/3

Completed

Start Date: 2020, October 19

Estimated study completion date: 2022, May 5

Experimental Part 1: Molnupiravir 200mg PO q12hrs for 5 days

Experimental Part 1: Molnupiravir 400mg PO q12hrs for 5 days

Experimental Part 1: Molnupiravir 800mg PO q12hrs for 5 days

Experimental Part 2: Molnupiravir (dose TBD) PO q12hrs for 5 days

Placebo comparator: Placebo matching tablet PO q12hrs for 5 days

Adult (18+), mild-moderate COVID-19 for under 7 days

1734 participants

Jayk Bernal A, Gomes da Silva MM, Musungaie DB, Kovalchuk E, Gonzalez A, Delos Reyes V, Martín-Quirós A, Caraco Y, Williams-Diaz A, Brown ML, Du J, Pedley A, Assaid C, Strizki J, Grobler JA, Shamsuddin HH, Tipping R, Wan H, Paschke A, Butterton JR, Johnson MG, De Anda C; MOVe-OUT Study Group. Molnupiravir for Oral Treatment of Covid-19 in Nonhospitalized Patients. N Engl J Med. 2022 Feb 10;386(6):509-520. doi: 10.1056/NEJMoa2116044. Epub 2021 Dec 16. PMID: 34914868; PMCID: PMC8693688. Johnson MG, Puenpatom A, Moncada PA, Burgess L, Duke ER, Ohmagari N, Wolf T, Bassetti M, Bhagani S, Ghosn J, Zhang Y, Wan H, Williams-Diaz A, Brown ML, Paschke A, De Anda C. Effect of Molnupiravir on Biomarkers, Respiratory Interventions, and Medical Services in COVID-19 : A Randomized, Placebo-Controlled Trial. Ann Intern Med. 2022 Jun 7:M22-0729. doi: 10.7326/M22-0729. Epub ahead of print. PMID: 35667065; PMCID: PMC9186515.

Naltrexone

British Columbia Women’s hospital (2022-06-01)

H21-02254 Control # 263975

A double blind randomized trial for low-dose naltrexone for post-covid fatigue syndrome

NCT05430152

Phase 2

Not yet recruiting

Estimated start date: 2023, March

Estimated completion date: 2024, February

Experimental: 1mg Naltrexone (low dose) titrated up by 1mg/week until max dose of 4.5mg for 16 weeks.

Placebo comparator

19+, Confirmed past SARS-CoV-2 positive, persistent synptoms of fatigue post-viral infection (PVI) (Long-COVID/post-COVID syndrome)s

60 participants

No results posted

Nirmaltrelvir (PF-07321332) / Ritonavir (Paxlovid)

Pfizer Canada ULC (2022-08-02)

C4671034 Control # 265231

An interventional efficacy and safety, phase 2, randomized, double-blind, 3 arm study to investigate nirmatrelvir/ritonavir in non-hospitalized particicpants at least 12 years of age with symptomatic covid 19 who are immunocompromised

NCT05438602

Phase 2

Recruiting

Start date: 2022, August 3

Estimated completion date: 2023, November 13

Experimental: 300mg Nirmaltrelvir BID for 5 days + 100mg Ritonavir BID for 10 days

Experimental: 300mg Nirmaltrelvir BID for 10 days + 100mg Ritonavir BID for 5 days

Experimental: 300mg Nirmaltrelvir BID + 100mg Ritonavir BID for 15 days

Placebo comparator

12 years +, SARS-CoV-2 positive, immunocompromised

200 participants

No results posted

Nirmaltrelvir (PF-07321332) / Ritonavir (Paxlovid)

Pfizer Canada ULC (2022-10-28)

C4671042 /control # 268341

An interventional, efficacy and safety, phase 2, randomized, double-blind, 2-arm study to investigate a repeat 5-day course of nirmatrelvir/ritonavir compared to placebo/ritonavir in participants at least 12 years of age with rebound of COVID-19 symptoms and rapid antigen test positivity

NCT05567952

Phase 2

Recruiting

Start date: 2022, October 19

Estimated completion date: 2023, November 28

Experimental: Nirmatrelvir (2 tablets) plus ritonavir (1 capsule) PO BID for 5 days

Comparator: placebo (2 tablets) plus ritonavir (1 capsule) PO BID for 5 days

12 + years, Documentation of nirmatrelvir/ritonavir treatment with patient-reported 100% compliance. Symptom alleviation or resolution in COVID-19 signs/symptoms followed by a worsening (rebound) of signs/symptoms after completing an initial 5-day course of nirmatrelvir/ritonavir

411 participants

No results posted

Nirmaltrelvir/ Ritonavir (Paxlovid)

Unity Health Toronto (2022-11-02)

CANTREATCOVID-1 / control # 269011 (Authorized under the COVID-19 Regulations)

Canadian adaptive platform trials of treatments for COVID in Community Settings (CanTreatCOVID)

NCT05614349

Phase 3

Recruiting

Start date: 2023, January 16

Estimated completion date: 2025, January

Experimental: Nirmatrelvir/ritonavir (Paxlovid™) BD x 5 days

No Intervention: Control group - Usual care (i.e., supportive care and symptom relief)

Experimental: Other Emerging Interventions (Additional treatment regimens will be decided by the Canadian COVID-19 Out-Patient Therapeutics Committee based on doses and durations studied in past trials and the latest evidence)

18 +, SARS-CoV-2 positive, outpatient, 1 or more chronic high risk medical condition

12000 participants

No results posted

Nitric oxide

University Health Network (2020-06-25)

20-5449 (Control # 239579)

Use of high dose inhaled nitric oxide in intubated patients admitted with COVID-19

NCT04383002

Phase 1

Completed

Start Date: 2020, September 2

Estimated study completion date: 2021, June 11

Experimental: Nitric Oxide 160ppm for 6 hours (inhaled) QD for 2 days

No Intervention: Clinical standard of care

Adult, COVID-19 (<14 days from symptom onset), mechanical ventilation (<7 days from intubation)

20 participants

No results posted

Nitric Oxide

Beyond Air Inc. (2020-05-19)

BAI_COV19_01 (control #239071)

Inhaled NO for the treatment of COVID-19 caused by SARS-CoV-2

NCT04397692

Phase N/A

Terminated

Start Date: 2020, June 13

Termination date: 2020, September 30

Experimental: Nitric Oxide 80ppm inhaled via LungFit system QID

No intervention: Clinical standard of care

22-65 years, COVID-19, Hospitalized (within 24hrs), oxygen saturation <93%, shortness of breath (onset within previous 8 days)

4 participants

Terminated (Slow recruitment)

Nitric Oxide

Sanotize Research & Development Corp (2020-04-18)

COVID-CTP-01 (Control #237786)

Multi-center, randomized, controlled, phase II clinical efficacy study evaluating NORS treatment for the prevention and treatment of COVID-19 in Healthcare workers & individuals at risk of infection

NCT04337918

Phase 2

Completed

Start date: 2020, May 8

Study completion date: 2021, February 2

Experimental: Nitric Oxide (NO) gargle every morning, NO nasopharyngeal irrigation every evening, and NO Nasal spray up to 5times a day for 14 days

No Intervention: clinical standard of care

Adult >19years, work/live with COVID-19 infected patients, COVID-19 negative, COVID-19 positive (sub-study)

143 participants (actual)

Nobody from the treatment arm got infected and strong safety data was shown (but peer-reviewed publication is not available)

Nitric Oxide

Sanotize Research & Development Corp. (2020-06-30)

COVID-CTP-02 (Control #240702)

Multi-center, double-blinded placebo-controlled, phase II clinical efficacy study evaluating NORS to treat and prevent the exacerbation of infection in individuals with documented mild COVID-19

NCT04443868

Phase 2

Withdrawn (no subjects enrolled)

Experimental: Nitric oxide-releasing drug Nasal spray + Nasal Irrigation

Placebo Comparator: Placebo

Adult, mild COVID-19 no flu-like symptoms

0 participants

Withdrawn (no subjects enrolled)

Nitric Oxide

Sanotize Research & Development Corp. (2021-05-14)

COVID-NONS-04 (Control #252244)

Decentralized, randomized, double-blinded, placebo-controlled, phase 3 clinical efficacy study evaluating nitric oxide nasal spray (NONS) as prevention for treatment of individuals at risk of exposure to COVID-19 infection

NCT05109611

Phase 3

Active, not recruiting

Start date: 2021, November 20

Estimated study date: 2023, July 30

Experimental: Nitric oxide releasing solution (NORS) nasal spray up to 3 times daily

Placebo comparator

18+, healthy (or stable chronic condition)

1389 participants

Not posted

Nitric Oxide

Sanotize Research & Development Corp. (2021-05-25)

COVID-NONS-05 (Control #252713)

Multi-center, double-blinded, placebo-controlled parallel, phase 3 clinical efficacy study evaluating nitric oxide nasal spray (NONS) to treat and prevent the exacerbation of infection in individuals with documented mild COVID-19

Phase 3

Nitric Oxide

Dr. Jeremy Road (2020-03-19)

NTM-CTP-01 (Control #236728)

An open label safety study of inhaled gaseous nitric oxide (gNO) for adults & adolescents with non-tuberculous mycobacteria

NCT03331445

Phase 2

Terminated

Start Date: 2017, October 24

Study termination date: 2021, June 30

Experimental: Nitric oxide 0.5%/Nitrogen 99.5% (gas) 160ppm inhaled

COVID-19 SubStudy- Adult, COVID-19 (within 5 days),

Original inclusion criteria - previously diagnosed with NTM, Burkholderia app, Aspergillus spp., or corona-like viral infection, > 14years, able to breath without supplemental oxygen, non-smoker

13 participants

Terminated (COVID incidence too low and funding completed)

Nitric Oxide

St. Paul’s Hospital Vancouver (2021-01-15)

COVID-NORS-01 (Control #247971)

The efficacy of topical nitric oxide releasing solutions (NORS) in the management of coronavirus disease 2019 (COVID-19)

Omalizumab (Xolair)

The Research Institute of the McGill University Health Centre (2020-12-21)

CIAO_COVID20 (control #246983)

COVID-19 immunologic antiviral therapy with omalizumab (CIAO trial) – An adaptive Phase II randomized-controlled clinical trial

NCT04720612

Phase 2

Active, not recruiting

Study start date: 2021, October 15

Estimate study completion date: 2022, December 16

Experimental: Omalizumab single subcutaneous dose 375mg

Placebo comparator: Normal saline single subcutaneous dose

18+, SARS-CoV-2 positive, hospitalized

40 participants

Results not posted

Oxygen

Ottawa Hospital Research Institute (2020-07-30)

OHRI-HBOT-001

Multicentre randomized controlled trial of hyperbaric versus normobaric oxygen therapy for COVID-19 patients

NCT04500626

Phase 2/3

Recruiting

Start Date: 2021, April 15

Estimated study completion date: 2022, August

Experimental: Hyperbaric oxygen therapy (HBOT) 2.0ATA for 75mins

No Intervention: standard of care (including normobaric oxygenation)

Adult, COVID-19, pneumonia requiring oxygenation but not mechanical ventilation

234 participants

No results posted

Ozanimod

Institut Universitaire de Cardiologie et de Pneumologie de Quebec (2020-07-13)

NCT04405102 (Control #241148)

A randomized trial on efficacy and safety of Ozanimod for the treatment of COVID-19 patients requiring oxygen support – a pilot trial (COZI)

NCT04405102

Phase 2

Terminated

Start Date: 2020, September 16

Termination date: 2022, May 12

Experimental: Ozanimod 0.23mg QD for 4 days followed by 0.46mg QD for 10 days

No Intervention: standard of care

18-85 years, COVID-19, BMI 20-35, hospitalized requiring oxygen but not ventilation

43 participants

Terminated (Screening was stopped by the Sponsor (43/48 participants enrolled), given the very low number of eligible patients (high vaccination rate and occurrence of the Omicron variant). The last patient randomized performed his follow-up visit.)

Peginterferon Lambda-1A

University Health Network (2020-04-29)

JF-4-2020 (Control #238558)

Interferon Lambda for immediate antiviral therapy at diagnosis (ILIAD): A phase II randomized, open-label, multicenter, trial to evaluate the effect of peginterferon lambda for the treatment of COVID-19

NCT04354259

Phase 2

Completed

Start Date: 2020, May 13

Study completion date: 2021, February 5

Experimental: Peginterferon lambda 180ug SC (one dose) (ambulatory cohort)

Experimental: Peginterferon lambda 180ug SC followed by a second dose on day 7 (hospitalized cohort)

Placebo comparator: Sodium chloride 0.9% SC (one dose)

Adult, COVID-19, at home (ambulatory cohort), hospitalized (hospitalized cohort)

140 participants

Peginterferon lambda accelerated viral decline in outpatients with COVID-19, increasing the proportion of patients with viral clearance by day 7, particularly in those with high baseline viral load. Peginterferon lambda has potential to prevent clinical deterioration and shorten duration of viral shedding.

Peginterferon Lambda-1A

Dr. Jordan Feld, University Health Network, Toronto General Hospital (2021-01-13)

JF-12-2020 (Control #247938)

Interferon lambda therapy for symptomatic SARS-CoV-2 early in infection (ODYSSEY): A phase III randomized, double-blind, placebo-controlled, multicenter trial to evaluate the effect of peginterferon lambda for the treatment of COVID-19

NCT04967430

Phase 3

Active, not recruiting

Start date: 2021, August 27

Estimated completion date: 2022, June 30

Experimental: Peginterferon lambda 180mcg SC, one dose

Placebo comparator

18 +, SARS-CoV-2 positive, symptomatic, high risk of severe disease, discharged to home isolation

763 participants

No results posted

Pentoxifylline, Ibudilast (MN-166)

University Health Network (2023-01-25 and 2023-02-03)

OZUHN-002 / control # 271420 (Authorized under the COVID-19 Regulations)

Recovering From COVID19 Lingering Symptoms Adaptive Integrative Medicine (RECLAIM)

NCT05513560

Phase 2/3

Not yet recruiting

Start Date: 2023, February (estimated)

Study completion date: 2025, July

Experimental: Ibudilast 20mg PO BID

Experimental: Pentoxifylline 400mg PO TID

Placebo comparator

18+, past SARS-CoV-2 positive result, lingering COVID-19 symptoms after 3 months of COVID-19 onset, with persistent COVID-19 symptoms (at least 2 months), post COVID Condition/Long COVID

1000 participants

No results posted

Perflenapent (NanO2)

Research Institute of the McGill University Health Centre (2020-06-10)

EXTENDED-P2 (Control #240041)

EXTENDED (Novel O Therapeutic NaNO2 for COVID-19 induced ARDS) Phase IIa Trial

Perflenapent (NanO2)

NuvOx Pharma LLC (2021-05-17)

COVID-NONS-04 (Control #252244)

EXTEND-P2 (Control #246808) Authorized under the clinical trials interim order

Polyriboinosinic acid-polyribocytidylic acid (Poly-ICLC) (Hiltonol)

Oncovir, Inc. (2020-09-25)

ONV2020-003 (Control #243532) Authorized under the Interim Order

A phase I-Ib, double-blinded, randomized repeated dose multicenter, safety and immunogenicity study of nasal Poly-ICLC (Hiltonol) for prophylaxis of COVID-19 in healthy adults

NCT04672291

Phase 1

Recruiting

Start date: 2021, July 21

Estimated study completion date: 2023, January 31

Experimental: Poly-ICLC 2 cycles (safety cohort)

Placebo: Placebo 2 cycles

Experimental: Poly-ICLC 3 cyles (expansion cohort)

Placebo: Placebo 3 cycles

Adult, healthy

43 participants

No results posted

Prednisone

Governors of the University of Alberta (2021-03-08)

CORE-COVID (Control #249936)

A randomized clinical trial comparing 7 days treatment with corticosteroids versus placebo for early COVID-19

NCT04795583

Phase 3

Withdrawn (Funding issue)

Experimental: Prednisone 50mg/day (if less than 50kg), 75mg/day (if 50-80kg), or 100mg/day (if greater than 80kg) for 7 days

Placebo comparator: Placebo capsules for 7 days

18+, SARS-CoV-2 positive

0 participants

Withdrawn (Funding issue)

Propranolol

Ottawa Hospital Research Institute (2020-06-10)

776228483 PROACTIVE (Control #240296)

Propanolol as an anxiolytic to reduce the use of sedatives for critically ill adults receiving mechanical ventilation: an open-label randomized controlled trial (PROACTIVE)

NCT04467086

Phase 3

Completed

Start Date: 2020, December 11

Study completion date: 2022, November 30

Experimental: Propranolol hydrochloride 20mg PO q6hrs for 2 doses, then 30mh q6hrs for 4 doses, 50mg q6hrs for 4 doses, 60mg q6hrs

No intervention: clinical standard of care

Adult (19+), ICU on mechanically ventilation

72 participants

No results posted

ProTrans (Wharton’s Jelly derived Umbilical Cord Mesenchymal Stromal Cells (UCMSC))

Research Institute of the McGill University Health Centre (2020-10-16)

2021-6954 (CTA Control #244461) filed under the Interim Order

Treatment of respiratory complications associated with COVID-19 infection using Wharton’s Jelly (WJ)-umbilical cord (UC) mesenchymal stromal cells (ProTrans): a randomized phase II controlled clinical trial

NCT04869397

Phase 2

Recruiting

Start date: 2021, June 14

Estimated completion date: 2022, July 30

Experimental: Allogeneic Wharton’s jelly-MSCs (WJ-MSC) IV, one dose of 5 million cells/minute over 20 minutes

Placebo comparator

18+, SARS-CoV-2 positive, hospitalized but not ventilated

48 participants

Not posted

Pulmozyme (Dornase Alfa, rhDNase1)

The Research Institute of McGill University Health Centre (2020-07-24)

DISCONNECT-1 CTA Control #241689

DISmentling COvid iNduced Neutrophil ExtraCellular Traps (DISCONNECT-1): Phase I pilot study investigating the safety and feasibility of inhaled rhDNase1 and its impact on neutrophil extracellular traps (NETs) in non-ventilated COVID-19 infected patients

NCT04409925

Phase 1

Unknown

Start Date: 2020, December 25

Estimated study completion date: 2021, August

Experimental: rhDNase1 (Pulmozyme) 2.5mg inhaled BID for a maximum of 14 days

Adult, COVID-19, hospitalized on oxygen but not ventilation

25 participants

No results posted

Recombinant human alkaline phosphatase

AM-PHARM A B.V (2020-09-11)

AP-RECAP-AKI-03-01 (Control #243263)

A randomized, double-blind, placebo-controlled, two-arm parallel-group, multi-center Phase 3 pivotal trial to investigate the efficacy and safety of recombinant human alkaline phosphatase for treatment of patients with sepsis associated acute kidney injury

NCT04411472

Phase 3

Terminated

Start Date: 2020, October 15 (estimated)

Termination date: 2022, August 18

Experimental: recombinant human alkaline phosphatase 1.6mg/kg TID infusions

Placebo comparator: matching placebo

Adult, ICU or intermediate care unit, sepsis requiring vasopressor therapy

661 participants

NTerminated (The Data Monitoring Committee (DMC) concluded that the pre-specified futility threshold was met and that there was no safety concern)

Recombinant human annexin A5 (SY-005)

Lawson Health Research Institute (2021-02-05)

REDA-10122 (Control #248696) Authorized under the clinical trials interim order

Annexin A5 in patients with severe COVID-19 disease

NCT04748757

Phase 2

Recruiting

Start date: 2021, April 20

Estimated study completion date: 2022, December

Placebo comparator: Normal saline 50mL infusion over 30mins every 12hrs for 7days

Experimental: Recombinant human annexin A5 (SY-005) 50microg/kg in 50ml saline infusion over 30mins every 12hrs for 7days (low dose)

Experimental: Recombinant human annexin A5 (SY-005) 100microg/kg in 50ml saline infusion over 30mins every 12hrs for 7days (high dose)

19+, SARS-CoV-2 positive, admitted to ICU for organ failure support

60 participants

Not yet posted

Remdesivir

Gilead Sciences Canada Inc. (2020-04-15)

GS-US-540-5821 (Control #238163)

Expanded access treatment protocol: Remdesivir (RDV; GS-5734) for the treatment of SARS-COV2 (COV) infection

NCT04323761

No longer available

Remdesivir, interferon beta-1a

Sunnybrook Research Institute (2020-03-18)

CATCO 2114 (Control #237108)

The Canadian arm of the WHO SOLIDARITY trial. A multi-centre, adaptive, randomized, open-label, controlled clinical trial of the safety and efficacy of investigational therapeutics for the treatment of COVID-19 in hospitalized patients

NCT04330690

Phase 2

Recruiting

Start Date: 2020, March 18

Estimated study completion date: 2024, May 18

Experimental: Lopinavir/ritonavir 400mg/100mg PO for 14 days or until hospital discharge

Experimental: Hydroxychloroquine 800mg BID for 1 day, then 400mh BID for 10 days

Experimental: Remdesivir 200mg IV on day 1, then 100mg IV QD for 9 days

No Intervention: Clinical standard of care

Adult, COVID-19, Hospitalized

2900 participants

No results yet posted (although the lopinavir/ritonavir and hydroxychloroquine arms have been stopped)

Remestemcel-L

Mesoblast, Inc (2020-07-31)

CTSN-MSC-ARDS001 (Control #241138)

Mesenchymal stem cells for the treatment of moderate to severe COVID-19 acute respiratory distress syndrome

NCT04371393

Phase 3

Terminated

Start Date: 2020, April 30

Termination date: 2022, January 2

Experimental: Remestemcel-L 2x10^6 MSC/kg IV on day 1 and day 4

Placebo Comparator: Plasma-Lyte (placebo) on day 1 and day 4

Adult, COVID-19, ARDS, mechanical ventilated

223 participants

Terminated (At 3d interim analysis, randomization, but not follow-up, was halted by the DSMB due to low predictive probability of achieving postulated mortality benefit (pre-specified 42.5% relative mortality reduction) were the trial to complete randomization.)

Ribavirin (Virazole)

Valeant Canada LP/Valeant Canada S.E.C. (2020-04-08)

BHC-RIB 5401-HC (Control #238007)

An open label study to evaluate the safety and efficacy of virazole (ribavirin for inhalation solution, USP) in hospitalized adult participants with respiratory distress due to COVID-19

NCT04356677

Phase 1

Withdrawn

Experimental: Virazole 50mg/mL aerosolized BID up to 6 days

Experimental: Virazole 100mg/mL aerosolized BID up to 6 days

Adult, COVID-19, hospitalized

0 participants

Withdrawn (Due to pandemic status changing in Canada prior to investigative sites being initiated for participation, and that concurrent participant recruitment in the global study BHC-RIB-5401-GL will achieve target enrollment across all countries)

Ruxolitinib (Jakavi)

Novartis Pharmaceuticals Canada Inc. (2020-06-16)

CINC424J12301 RUXCOVID (Control #237332)

Phase 3 randomized, double-blind, placebo-controlled, multi-centre study to assess the efficacy and safety of ruxolitinib in patients with COVID-19 associated cytokine storm (RUXCOVID)

NCT04362137

Phase 3

Completed

Start Date: 2020, May 2

Study completion date: 2020, October 17

Experimental: Ruxolitinib 5mg PO BID for 14 days with possible extension to 28 days

Placebo Comparator: Placebo PO BID for 14 days with possible extension to 28 days

Age 12+, COVID-19, hospitalized, sign of decreased lung capacity or damage

432 participants (actual)

Did not meet its primary ot secondary endpoints

Ruxolitinib

University Health Network (2020-04-07)

U-DEPLOY (OZUHN-001/Sub protocol # OZUHN-001-2) (Control #237848)

Umbrella trial defining coordinated approach to pandemic trials of COVID-19 and data harmonization to accelerate discovery (sub-study of the larger study)

NCT04331665

Phase N/A

Completed

Start Date: 2020, May 21

Study completion date: 2021, March 24

Experimental: Ruxolitinib 10mg BID for 14 days, followed by 5mg BID for 2 days and 5mg QD for 1 day

12 years+, COVID-19, needing supplemental oxygen

3 participants

Terminated

Sarilumab (Kevzara)

Sanofi-Aventis Canada Inc. (2020-03-24)

SAR153191 (Control #237332)

An adaptive phase 2/3 randomized, double-blind, placebo-controlled study assessing efficacy and safety of sarilumab for hospitalized patients with COVID-19

NCT04315298

Phase 2/3

Completed

Start Date: 2020, March 18

Study completion date: 2020, September 2

Experimental: Sarilumab (low dose) IV

Experimental: Sarilumab (mid dose) IV

Experimental: Sarilumab (high dose) IV

Adult, COVID-19, hospitalized, pneumonia, Phase 2: must have severe disease, critical disease, multi-system organ dysfunction, or immunocompromised, Phase 3: receiving mechanical ventilation 

1912 participants (actual)

Did not meet its primary or secondary endpoints

Semaglutide (Ozempic)

University Health Network (2020-10-07)

UHNSEMPATICO1 (Control #244389)

Semaglutide to reduce myocardial injury in patients with COVID-19

NCT04615871

Phase 2

Recruiting

Start date: 2021, September 10

Estimated Study Completion date: 2022, March 31

Experimental: Semaglutide 0.25mg S.C., then 0.5mg on Day 7, Day 14, and Day 21

No intervention: Clinical standard of care

Adult (18+), COVID-19, hospitalized, with two other high-risk features

400 participants

No results posted

Tocilizumab (Actemra)

University of Calgary (2020-05-22)

REB20-0713 (CTA Control # 239287)

(A prospective, observational study) (A Nested Interventional Cohort Study) to assess the efficacy and safety of adjunctive humanized monoclonal Interleukin 6 receptor antibody Tocilizumab (TCZ) therapy to standard of care for the reduction of hyperinflammation related mortality in SARS-CoV-2 positive patients (Tocilizumab in Coronavirus-19 Positive Patients)

NCT04423042

Phase 3

Unknown

Start Date: 2020, July 30 (estimated)

Estimated study completion date: 2021, June

Experimental: Tocilizumab 8mg/kg IV up to a maximum of 800mg with a possible repetition of the same dose after 12hrs but within 28hrs

No Intervention: Clinical Standard of Care

Adult, COVID-19, experiencing hyperinflammation (Elevated C-reactive protein (>70mg/dl or raising over a 24h period), Ferritin (>700mcg/L or rising over a 24h period)

30 participants

No results posted

Tocilizumab (Actemra/RoActemra)

Hoffman-La Roche Limited (2020-03-25)

COVACTA (Control # 237397)

A randomised, double-blind, placebo-controlled, multicentre study to evaluate the safety and efficacy of tocilizumab in patients with severe COVID-19 pneumonia (A study to evaluate the safety and efficacy of tocilizumab in patients with severe COVID-19 pneumonia)

NCT04320615

Phase 3

Completed

Start Date: 2020, April 3

Study completion date: 2020, July 28

Experimental: Tocilizumab (TCZ) 8mg/kg up to a maximum of 800mg IV (one additional dose may be added if clinical symptoms worsen or no improvement)

Placebo Comparator: Placebo matched to TCZ dose IV

Adult, COVID-19, hospitalized, pneumonia

450 participants (actual enrollment)

CONVACTA did not meet its primary endpoint of improved clinical status in patients with COVID-19 associated pneumonia, or the key secondary endpoint of reduced patient mortality

Roche remains committed to continuing the Actemra/RoActemra clinical trial programme in COVID-19 to further explore Actemra/RoActemra in other treatment settings, including in combination with an antiviral

Vitamin C

Centre de Recherche du Centre Hospitalier Universitaire de Sherbrooke (2020-06-05)

LOVIT-COVID MP-31-2021-3741

Lessening Organ Dysfunction with VITamin C – COVID (LOVITCOVID)

NCT04401150

Phase 3

Suspended

Start Date: 2020, August 14

Estimated study completion date: 2022, December

Experimental: Vitamin C 50mg/kg IV q6hrs for 96hrs (16 doses)

Placebo comparator: Normal saline (0.9% NaCl) IV q6hrs for 96hrs (16 doses)

Adult, COVID-19, Hospitalized

800 participants

Suspended (On July 15, 2022, the LOVIT-COVID DSMB was aware of the recommendation of the REMAP-CAP DSMB to cease enrollment into the Vitamin C domain of that trial. Given that, the LOVIT-COVID DSMB suggested pausing enrollment into LOVIT-COVID immediately.)

Vitamin C (ascorbic acid)

Centre de Recherche du Centre Hospitalier Universitaire de Sherbrooke (2020-03-18)

MP-31-2019-2945 (Control #237164)

Lessening Organ Dysfunction with Vitamin C (LOVIT)

NCT03680274

Phase 3

Completed

Start Date: 2018, November 8

Completion date: 2022, January 24

Experimental: Vitamin C 50mg/kg IV q6hrs for 96hrs (16 doses)

Placebo comparator: Dextrose in H2O or normal saline (0.9% NaCl) IV q6hrs for 96hrs (16 doses)

Adult, ICU with proven or suspected infection, being treated with IV infusion of vasopressors

872 participants

Lamontagne F, Masse MH, Menard J, Sprague S, Pinto R, Heyland DK, Cook DJ, Battista MC, Day AG, Guyatt GH, Kanji S, Parke R, McGuinness SP, Tirupakuzhi Vijayaraghavan BK, Annane D, Cohen D, Arabi YM, Bolduc B, Marinoff N, Rochwerg B, Millen T, Meade MO, Hand L, Watpool I, Porteous R, Young PJ, D'Aragon F, Belley-Cote EP, Carbonneau E, Clarke F, Maslove DM, Hunt M, Chassé M, Lebrasseur M, Lauzier F, Mehta S, Quiroz-Martinez H, Rewa OG, Charbonney E, Seely AJE, Kutsogiannis DJ, LeBlanc R, Mekontso-Dessap A, Mele TS, Turgeon AF, Wood G, Kohli SS, Shahin J, Twardowski P, Adhikari NKJ; LOVIT Investigators and the Canadian Critical Care Trials Group. Intravenous Vitamin C in Adults with Sepsis in the Intensive Care Unit. N Engl J Med. 2022 Jun 23;386(25):2387-2398. doi: 10.1056/NEJMoa2200644. Epub 2022 Jun 15. PMID: 35704292.

Vitamin D

Governors of the University of Alberta (2020-07-27)

PRO00100606 (Control #240943)

Improving vitamin D status in the management of COVID-19

NCT04385940

Phase 3

Recruiting

Start Date: 2021, March 19

Estimated study completion date: 2023, January

Experimental: Vitamin D3 50 000 IU PO

Active Comparator: Vitamin D3 1000 IU PO

17 years +, COVID-19

64 participants

No results posted

Vitamin D/Vitamin K-Vitamin D/Vitamin C/Zinc

Ottawa Hospital Research Institute (2021-05-21)

20210072-01H (Control #251410)

Dietary supplements to reduce symptoms severity and duration in people with SARS-CoV-2: A randomized, double-blind, placebo controlled clinical trial

NCT04780061

Phase 3

Terminated

Start date: 2021, July 12

Estimated completion date: 2022, December

Experimental: Cholecalciferol (Vitamin D3) 500mg (50 000units) one dose on day 1 then menaquione-7 (MK-7, vitamin K2) 0.114 ML twice daily, and cholecalciferol 1 000 units daily, and 2g ascorbic acid (vitamin C)/25mg zinc acetate combo three times a day for 21 days

Placebo comparator: microcrystalline cellulose capsules and medium chain triglyceride oil

18+, SARS-CoV-2 positive, outpatient

200 participants

Terminated (Public PCR testing stopped in Ontario)

VIR-7831

Vir Biotechnology Inc. (2020-10-13)

VIR-7831-5001 CTA

(Control #244708) Filed under the Interim Order

A randomized multi-center, double-blind, placebo-controlled study to assess the safety and efficacy of monoclonal antibody VIR-7831 for the early treatment of coronavirus disease 2019 (COVID-19) in non-hospitalized patients

NCT04545060

Phase 2/3

Completed

Start date: 2020, August 27

Study completion date: 2021, September 2

Experimental: VIR-7831 IV infusion

Placebo comparator: Normal saline (0.9% NaCl) IV infusion

Adult, COVID19, high risk of COVID19 progression or >55 years

1057 participants

No results posted

VIR-7831 (GSK4182136)

Vir Biotechnology Inc. (2021-04-09)

216912 (Control #250948) authorized under the clinical trials interim order

A multicenter, randomized, double-blind, parallel group phase II study to evaluate the safety, tolerability and pharmacokinetics of a second generation VIR-7831 material in non-hospitalized participants with mild to moderate coronavirus disease 2019 (COVID-19)

NCT04779879

Phase 2

Completed

Study start date: 2021, February 18

Completion date: 2022, April 6

Experimental: VIR-7831 (Gen2) IV

Active comparator: VIR-7831 (Gen1) IV

18+, SARS-CoV-2 positive, outpatient

352 participants

No results posted

Vortioxetine

Brain and Cognition Discovery Foundation (2021-08-17)

BCDF002 (Control #255061)

Randomized, double-blinded, placebo-controlled study evaluating vortioxetine for cognitive deficits in persons with post-COVID-19 syndrome

NCT05047952

Phase 2

Recruiting

Study start date: September 16, 2021

Estimated completion date: 2023, January

Experimental: Vortioxetine 10mg OD for 2 weeks, then titrated up to 20mg OD for weeks 2-8

Placebo comparator: Placebo capsule OD for 8 weeks

Adult (18-65), post-COVID-19 syndrome

200 participants

No results posted

Vaccine: Ad26.COV2.S (JNJ-78436735)

Janssen Inc. (2020-12-14)

VAC31518COV2001 (Control #246908) Authorized under clinical trials interim order

A randomized, double-blind, placebo-controlled Phase 2a study to evaluate a range of dose levels and vaccination intervals of Ad26.COV2.S in healthy adults aged 18 to 55 years and older and to evaluate 2 dose levels of Ad26.COV2.S in healthy adolescents aged 12 to 17 years inclusive

NCT04535453

Phase 2

Completed

Start date: 2020, August 28

Completion date: 2022, March 9

Experimental: Groups 1-3 - Ad26.COV2.S, 2-dose regiment at different dose levels on day 1 and 57

Groups 4-5 - Ad26.COV2.S single dose

Group 6 - placebo

Group 7 - Ad26.COV2.S, 2-dose regiment at fixed dose level on day 1 and 29

Group 8 - placebo on day 1 and 29

Group 9 - Ad26.COV2.S, 2-dose regiment at fixed dose level on day 1 and 85

Group 10 - placebo on day 1 and 85

Group A & D- Ad26.COV2.S, 1-dose regiment at fixed dose plus a booster vaccination 12 months later

Group B & E - Ad26.COV2.S, 2-dose regiment at fixed dose on Day 1 and 57 plus a booster vaccination 12 months later

Group C & F- placebo, 2-dose regiment at fixed dose plus a booster vaccination 12 months later

Ages 12-55 and 65+, healthy

635 participants

Sadoff J, Le Gars M, Brandenburg B, Cárdenas V, Shukarev G, Vaissiere N, Heerwegh D, Truyers C, de Groot AM, Jongeneelen M, Kaszas K, Tolboom J, Scheper G, Hendriks J, Ruiz-Guiñazú J, Struyf F, Van Hoof J, Douoguih M, Schuitemaker H. Durable antibody responses elicited by 1 dose of Ad26.COV2.S and substantial increase after boosting: 2 randomized clinical trials. Vaccine. 2022 Jun 3:S0264-410X(22)00666-1. doi: 10.1016/j.vaccine.2022.05.047. Epub ahead of print. PMID: 35667914; PMCID: PMC9165876.

Vaccine: Ad26.COV2.S (JNJ-78436735)

Janssen Inc. (2021-03-17)

VAC31518COV2004 (Control #250107) Authorized under the clinical trials interim order

An open-label, phase 2 study to evaluate the safety, reactogenicity, and immunogenicity of Ad26.COV2.S in healthy pregnant participants

NCT04765384

Phase 2

Active, not recruiting

Start date: 2021, August 27

Estimated study completion date: 2024, May

Experimental: Ad26.COV2.S IM injection on Day 1 and 57

18-45 years, healthy, pregnant (between week 16-38)

51 participants

No results posted

Vaccine: AdCOVID Vaccine

Altimmune, Inc. (2021-05-26)

ALT-501-102 (Control #252058) Authorized under the Clinical Trials Interim Order

A phase 1, open-label study to evaluate the effect of position and duration on the safety and immunogenicity of intranasal AdCOVID administration

CT04679909

Phase 1

Active, not recruiting

Start date: 2021, February 25

Estimated study completion date: 2022, February

Experimental: Single low dose AdCOVID, intranasal

Experimental: Single medium dose AdCOVID, intranasal

Experimental: Single high dose AdCOVID, intranasal

Experimental: Two low dose AdCOVID, intranasal

Experimental: Two medium dose AdCOVID, intranasal

Experimental: Two high dose AdCOVID, intranasal

Placebo comparator: Single dose placebo, intranasal

Placebo comparator: Two dose placebo, intranasal

18-55 years, healthy

92 participants

No results posted

Vaccine: BNT162b2 mRNA COVID-19 vaccine (Pfizer-BioNTech vaccine)/ mRNA-1273 SARS-CoV-2 vaccine (Moderna vaccine)

Sunnybrook Research Institute (2021-09-02)

3750 (Control #255889) Authorized under the clinical trials interim order

BOOST KIDNEY: A multi-centre 12 month parallel-group randomized control trial of BNT162b2 versus mRNA-1273 COVID-19 vaccine boosters in chronic kidney disease and dialysis patients with poor humoral response following COVID-19 vaccination

NCT05022329

Phase 2/3

Active, not recruiting

Study start date: September 30, 2021

Estimated study completion date: August 30, 2023

Experimental: BNT162b2 or mRNA-1273 SARS-CoV-2 vaccine, one dose IM

Adult (18+), chronic kidney disease stage 3b-5, already received two-doses of a mRNA vaccine with the second dose being given 2-12 months previously

268 participants

No results posted

Vaccine: ChAd-CoV/Mac /Ad5-CoV/Mac

McMaster University (2021-10-21)

M010 (Control #257190)

Phase 1, Open Label Study to Evaluate the Safety and Immunogenicity of ChAd68 and AdHu5 vector-based Trivalent COVID-19 Vaccine Delivered Via Inhaled Aerosol

NCT05094609

Phase 1

Recruiting

Start date: 2022, January 3

Estimated study completion date: 2023, December 31

Experimental: Ad5-triCoV/Mac 10e5 (low dose) single dose by inhalation

Experimental: ChAd-triCoV/Mac 10e5 (low dose) single dose by inhalation

Experimental: Ad5-triCoV/Mac 10e6 (higher dose) single dose by inhalation

Experimental: ChAd-triCoV/Mac 10e6 (higher dose) single dose by inhalation

18-65 years, healthy, doubled vaccinated with mRNA vaccines

30 participants

No results posted

Vaccine: Coronavirus-like particle (CoVLP) COVID-19 Vaccine

Medicago Inc. (2020-07-09)

CP-PRO-CoVLP-019 (Control #240922)

A randomized, partially-blinded, dose-ranging phase 1 study to assess the safety, tolerability, and immunogenicity of a recombinant coronavirus-like particle COVID-19 vaccine in adults 18-55 years of age

NCT04450004

Phase 1

Completed

Start Date: 2020, July 10

Completion date: 2021, August 30

Experimental: Coronavirus-like particle COVID-19 Vaccine unadjuvanted 3.75ug IM on day 0 and Day 21

Experimental: Coronavirus-like particle COVID-19 Vaccine adjuvanted with CpG 1018 3.75ug IM on day 0 and Day 21

Experimental: Coronavirus-like particle COVID-19 Vaccine adjuvanted with AS03 3.75ug IM on day 0 and Day 21

Experimental: Coronavirus-like particle COVID-19 Vaccine unadjuvanted 7.5ug IM on day 0 and Day 21

Experimental: Coronavirus-like particle COVID-19 Vaccine adjuvanted with CpG 1018 7.5ug IM on day 0 and Day 21

Experimental: Coronavirus-like particle COVID-19 Vaccine adjuvanted with AS03 7.5ug IM on day 0 and Day 21

Experimental: Coronavirus-like particle COVID-19 Vaccine unadjuvanted 15ug IM on day 0 and Day 21

Experimental: Coronavirus-like particle COVID-19 Vaccine adjuvanted with CpG 1018 15ug IM on day 0 and Day 21

Experimental: Coronavirus-like particle COVID-19 Vaccine adjuvanted with AS03 15ug IM on day 0 and Day 21

18-55 years, healthy

180 participants

NWard BJ, Gobeil P, Séguin A, Atkins J, Boulay I, Charbonneau PY, Couture M, D'Aoust MA, Dhaliwall J, Finkle C, Hager K, Mahmood A, Makarkov A, Cheng MP, Pillet S, Schimke P, St-Martin S, Trépanier S, Landry N. Phase 1 randomized trial of a plant-derived virus-like particle vaccine for COVID-19. Nat Med. 2021 Jun;27(6):1071-1078. doi: 10.1038/s41591-021-01370-1. Epub 2021 May 18. PMID: 34007070; PMCID: PMC8205852

Vaccine: Coronavirus-like particle (CoVLP) COVID-19 Vaccine

Medicago Inc. (2020-11-09)

CP-PRO-CoVLP-021 (CTA Control #245149) filed under the IO

A randomized, observer-blind, placebo-controlled phase 2/3 study to assess the safety, efficacy, and immunogenicity of a recombinant coronavirus-like particle COVID-19 vaccine in adults 18 years of age

NCT04636697

Phase 2/3

Completed

Study start date: 2020, November 19

Estimated study completion date: 2022, April 30

Experimental: CoVLP adjuvanted vaccine 3.75microg with 0.5mL of AS03 adjuvant 2 doses IM 21days apart

Placebo comparator: Placebo 0.5mL IM two doses 21 days apart

18+ years,healthy

24141 participants

Completed – Showed benefit- Vaccine is 69.5% effective in preventing symptomatic COVID-19 infection and 78.8% effective against moderate-to-severe disease. Hager KJ, Pérez Marc G, Gobeil P, Diaz RS, Heizer G, Llapur C, Makarkov AI, Vasconcellos E, Pillet S, Riera F, Saxena P, Geller Wolff P, Bhutada K, Wallace G, Aazami H, Jones CE, Polack FP, Ferrara L, Atkins J, Boulay I, Dhaliwall J, Charland N, Couture MMJ, Jiang-Wright J, Landry N, Lapointe S, Lorin A, Mahmood A, Moulton LH, Pahmer E, Parent J, Séguin A, Tran L, Breuer T, Ceregido MA, Koutsoukos M, Roman F, Namba J, D'Aoust MA, Trepanier S, Kimura Y, Ward BJ; CoVLP Study Team. Efficacy and Safety of a Recombinant Plant-Based Adjuvanted Covid-19 Vaccine. N Engl J Med. 2022 Jun 2;386(22):2084-2096. doi: 10.1056/NEJMoa2201300. Epub 2022 May 4. PMID: 35507508; PMCID: PMC9127773.

Vaccine: COVAC-1 (nCOV19 S1)

University of Saskatchewan (2022-09-28)

COVAC-1 (Control # 267708) Authorized under the Clinical Trials for Medical Devices and Drugs Relating to COVID-19 Regulations

A Randomized, Observer-Blind, Dose Escalation, Placebo-Controlled, Phase 1 Clinical Trial To Study The Safety And Immunogenicity Of A Covac-1 Booster Dose In Generally Healthy Adults

NCT05693272

Phase 1

Not yet recruiting

Study start date: 2023, February 10 (estimated)

Estimated study completion date: 2024, May 30

Experimental: COVAC-01 10µg IM one dose

Experimental: COVAC-01 25µg IM one dose

Experimental: COVAC-01 50µg IM one dose

Placebo Comparator: saline IM one dose

18-65 years, healthy, two or more doses of COVID-19 vaccine(s)

48 participants

No results posted

Vaccine: COVAC-2 (nCoV19 S1)

VIDO-InterVac, University of Saskatchewan (2020-12-22)

COVAC-001 (Control #247198) Authorized under Clinical Trials Interim Order

A randomized, observer-blind, dose-escalation Phase I/II clinical trial of COVAC vaccines in healthy adults

NCT04702178 (Phase 1)

NCT05209009 (Phase 2)

Phase 1/2

Active, not recruiting (Phase 1); Recruiting (Phase 2)

Study start date: 2021, February 10 (Phase 1); 2022, August 24 (Phase 2)

Estimated study completion date: 2023, April (Phase 1); 2023, August (Phase 2)

Experimental: COVAC-2 25microg IM injection two doses 28 days apart (Phase 1/2)

Placebo comparator: Saline IM injection two doses 28 days apart (Phase 1/2)

Experimental: COVAC-2 50microg IM injection two doses 28 days apart (Phase 1)

Experimental: COVAC-2 100microg IM injection two doses 28 days apart (Phase 1)

Healthy adults (18+)

72 participants (Phase 1); 300 participants (Phase 2)

No results posted

Vaccine: COVAC-2 (nCoV19 S1)

University of Saskatchewan, VIDO (2021-12-23)

COVAC-004 (Control #259104) Authorized under the Clinical Trials Interim Order

A Phase 1/2 clinical trial to study the safety, tolerability, and immunogenicity of a COVAC-2 booster dose in generally healthy adults

NCT05226702

Phase 1/2

Start date: 2022, July 22

Estimated completion date: 2023, December

Experimental: COVAC-2 10ug IM, one dose

Experimental: COVAC-2 25ug IM, one dose

Placebo comparator

Generally healthy adults (18+), vaccinated or previous history of SARS-CoV-2 infection

380 participants

No results posted

Vaccine: Covigenix VAX-001

Entos Pharmaceuticals Inc. (2021-03-24)

ENTVAX01-101 (Control #250321) Authorized under the Clinical Trials Interim Order

Phase I/II study to evaluate safety, tolerability, immunogenicity of a prophylactic plasmid DNA vaccine against SARS CoV-2 [covigenix VAX-001] in healthy adults from 18 to < 85 years of age

NCT04591184

Phase 1/2

Recruiting

Study start date: 2021, April 7

Estimated study completion date: 2023, December

Experimental: Covigenix VAX-001 two doses 14-42 days apart

Placebo comparator: placebo injection

18-84 years, healthy

36 participants

No results posted

Vaccine: IMM-101

Canadian Cancer Trials Group, Cancer Research Institute, Queen’s University (2020-06-24)

IC.8 (Control #240586) Filed under the clinical trial interim order

COV-IMMUNO- A randomized, Phase III trial of immunization with IMM-101 versus observation for the prevention of severe respiratory and COVID-19 related infections in cancer patients at increased risk of exposure

NCT04442048

Phase 3

Active, not recruiting

Start Date: 2020, June 25

Estimated study completion date: 2023, June 30

Experimental: IMM-101 Vaccine 1.0mg on day 0, then 0.5mg on Day 24, and 0.5mg on Day 45 (+/- 14 days)

No intervention: No active treatment, observation only

Adult, undergoing cancer-related treatment at a cancer clinic in hospital, have a risk factor for severe COVID-19 infection, have a life-expectancy of > 6 months, ECOG performance status <2, adequate organ function

195 participants

No results posted

Vaccine: mRNA-1273 SARS-CoV-2 vaccine (Moderna COVID-19 vaccine)

ModernaTX, Inc (2021-07-08)

mRNA-1273-P204 (Control #254169) Authorized under the clinical trials interim order

A phase 2/3, two-part, open-label, dose-escalation, age de-escalation and randomized, observer-blind, placebo-controlled, expansion study to evaluate the safety, tolerability, reactogenicity, and effectiveness of mRNA-1273 SARS-CoV-2 vaccine in healthy children 6 months to less than 12 years of age

NCT04796896

Phase 2/3

Completed

Start Date: Start date: March 15, 2021

Estimated study completion date: 2023, November 12

Experimental: mRNA-1273 vaccine 2 IM injections 28 days apart (Part 1- will assess 3 different doses, Part 2 will take the best dose forward)

Placebo comparator: 0.9% sodium chloride injection (Part 2 only)

Child (6 months to 11 years), healthy or stable chronic condition

13275 participants

Two 25-μg doses of the mRNA-1273 vaccine were found to be safe in children 6 months to 5 years of age and elicited immune responses that were noninferior to those in young adults. Anderson EJ, Creech CB, Berthaud V, Piramzadian A, Johnson KA, Zervos M, Garner F, Griffin C, Palanpurwala K, Turner M, Gerber J, Bennett RL, Ali K, Ampajwala M, Berman G, Nayak J, Chronis C, Rizzardi B, Muller WJ, Smith CA, Fuchs G, Hsia D, Tomassini JE, DeLucia D, Reuter C, Kuter B, Zhao X, Deng W, Zhou H, Ramirez Schrempp D, Hautzinger K, Girard B, Slobod K, McPhee R, Pajon R, Aunins A, Das R, Miller JM, Schnyder Ghamloush S; KidCOVE Study Group. Evaluation of mRNA-1273 Vaccine in Children 6 Months to 5 Years of Age. N Engl J Med. 2022 Oct 19. doi: 10.1056/NEJMoa2209367. Epub ahead of print. PMID: 36260859. Two 50-μg doses of the mRNA-1273 vaccine were found to be safe and effective in inducing immune responses and preventing Covid-19 in children 6 to 11 years of age; these responses were noninferior to those in young adults. Creech CB, Anderson E, Berthaud V, Yildirim I, Atz AM, Melendez Baez I, Finkelstein D, Pickrell P, Kirstein J, Yut C, Blair R, Clifford RA, Dunn M, Campbell JD, Montefiori DC, Tomassini JE, Zhao X, Deng W, Zhou H, Ramirez Schrempp D, Hautzinger K, Girard B, Slobod K, McPhee R, Pajon R, Das R, Miller JM, Schnyder Ghamloush S; KidCOVE Study Group. Evaluation of mRNA-1273 Covid-19 Vaccine in Children 6 to 11 Years of Age. N Engl J Med. 2022 May 26;386(21):2011-2023. doi: 10.1056/NEJMoa2203315. Epub 2022 May 11. PMID: 35544369; PMCID: PMC9127699.

Vaccine: mRNA-1273 SARS-CoV-2 vaccine (Moderna COVID-19 vaccine)

University Health Network (2021-04-26)

UHN-TID-COVAX-2 (Control #251583)

A randomised, single blind, controlled trial of third dose of Moderna vaccine versus placebo in solid organ transplant recipients

NCT04885907

Phase 4

Completed

Start date: 2021, May 25

Estimated completion date: 2021, August 30

Experimental: mRNA-1273 vaccine 0.5mL IM in deltoid muscle (3rd dose)

Placebo Comparator: Normal saline 0.5mL IM in deltoid muscle

18+, solid organ transplant recipient who has previously received two doses of Moderna vaccine

120 participants

In organ transplant recipients, a third dose of mRNA vaccine increases neutralizing antibody response against SARS-CoV-2 variants compared with placebo. Kumar D, Ferreira VH, Hall VG, Hu Q, Samson R, Ku T, Ierullo M, Majchrzak-Kita B, Tomlinson G, Gingras AC, Humar A. Neutralization of SARS-CoV-2 Variants in Transplant Recipients After Two and Three Doses of mRNA-1273 Vaccine : Secondary Analysis of a Randomized Trial. Ann Intern Med. 2022 Feb;175(2):226-233. doi: 10.7326/M21-3480. Epub 2021 Nov 23. PMID: 34807716; PMCID: PMC8628360.

Vaccine: mRNA-1273 SARS-CoV-2 vaccine (Moderna COVID-19 vaccine)

McMaster University (2021-08-13)

Moderna RCT LTCF (Control #255430) Authorized under the clinical trials interim order

Third dose of moderna mRNA-1273 COVID-19 vaccine in residents of long-term care facilities

NCT04978038

Phase 4

Not yet recruiting

Study start date: 2022, August 1 (estimated)

Estimated study completion date: 2022, December 31

Experimental: mRNA-1273 vaccine 0.5mL dose IM

Active comparator: Pfizer Prevnar-13 pneumococcal vaccine 0.5mL IM

65+, long-term care resident and already received two doses of the mRNA-1273 vaccine

414 participants

No results posted

Vaccine: PTX-COVID19-B

Providence Therapeutics Holdings Inc. (2020-12-22)

PRO-CL-001 (Control #246974) Authorized under Clinical Trials Interim Order

A Phase Ia/Ib, first-in-human, observer-blinded, randomized, placebo controlled, ascending dose study to evaluate the safety, tolerability, and immunogenicity of PTX-COVID19-B vaccine in healthy seronegative adults aged 18-64 and >65

NCT04765436

Phase 1

Active, not recruiting

Study start date: 2021, January 14

Estimated study completion date: 2022, February 14

Experimental: 16microg or 40microg or 100 microg PTX-COVID19-B IM injection two doses 28 days apart

Placebo comparator: 0.9% normal saline IM injection two doses 28 days apart

Adults (18+), healthy

60 participants

No results posted

Vaccine: PTX-COVID19-B/Pfizer-BioNTech COVID-19 Vaccine

Providence Therapeutics Holdings, Inc. (2021-07-20)

PRO-CL-002 (Control # 253878) Authorized under the clinical trials interim order

A Phase 2, randomized, observer-blind study to evaluate the safety, tolerability, and immunogenicity of PTX-COVID19-B compared to Pfizer-BioNTech COVID-19 Vaccine in healthy seronegative adults aged 18 to 64 years

NCT05175742

Phase 2

Active, not recruiting

Start date: 2021, August 17

Estimated completion date: 2023, March 31

Experimental: PTX-COVID19-B 40 ug IM, two doses 28 days apart

Experimental: PTX-COVID19-B 60 ug IM, two doses 28 days apart

Experimental: PTX-COVID19-B 80 ug IM, two doses 28 days apart

Experimental: PTX-COVID19-B 40 ug IM, two doses 28 days apart and a placebo dose on Day 21

Active comparator: Pfizer-BioNTech COVID-19 vaccine, two doses 21 days apart and placebo dose on Day 28

18-64 years, healthy

890 participants

No results posted

Vaccine: Recombinant Mycobacterium bovis BCG(delta)ureC::hly

Princess Margaret Cancer Centre (2002-05-08)

COBRA (Control #238868)

A randomized, double-blind, placebo-controlled phase 3 study: Efficacy and safety of recombinant BCG VPM1002 in reducing SARS-CoV-2 infection rate and COVID-19 severity

NCT04439045

Phase 3

Completed

Start Date: 2020, June 24

Estimated study completion date: 2021, September 9

Experimental: VPM1002 (reconstituted Mycobacterium bovis BCG(delta)ureC::hly, live 2-8 x 105 CFU) vaccine 0.1mL intradermal injection (one dose)

Placebo comparator: Sodium chloride (0.9%) 0.1mL intradermal injection

Adult, essential worker

122 participants

No results yet posted

Vaccine: Recombinant novel coronavirus vaccine (adenovirus Type 5) (Ad5-nCoV)

CanSino Biologics Inc. (2020-05-15)

Ad5-nCoV-2020003 (Control #239238)

A randomized, observer-blind, dose-escalation phase I/II clinical trial of Ad5-nCoV Vaccine in Healthy Adults from 18 to <85 years of age in Canada

NCT04398147

Phase 1/2

Withdrawn

Start Date: 2020, Aug 1 (estimated)

Estimated study completion date: 2021, December 30

Experimental: Ad5-nCoV containing 5E10 vp IM (single dose)

Placebo comparator: Placebo containing 0 vp IM

Experimental: Ad5-nCoV containing 5E10 vp IM 2 doses 56 days apart

Placebo comparator: Placebo containing 0 vp IM 2 doses 56 days apart

Experimental: Ad5-nCoV containing 10E10 vp IM (single dose)

Experimental: Ad5-nCoV containing 10E10 vp IM 2 doses 56 days apart

Adult 18-84 years, healthy

696 participants

Withdrawn

Vaccine: SPIKEVAX (Moderna vaccine) (Elasomeran (mRNA))

Research Institute of McGill University Health Centre (2021-11-08)

MP-37-2021-7562 (Control # 258049) Authorized under the clinical trials interim order

COVID-19 vaccine in immunosuppressed adults with autoimmune diseases

NCT04806113

Phase 3

Active, not recruiting

Start date: 2021, March 11

Estimated completion date: 2022, June 15

Experimental: Moderna mRNA vaccine two doses IM 28 days apart

18+, autoimmune disease (rheumatoid arthritis, systemic lupus erythematosus)

220 participants

No results posted

Vaccine: SPIKEVAX (Moderna vaccine/Elasomeran (mRNA)) / VAXZEVRIA (Oxford, AstraZeneca Vaccine/ ChAdOX1-S [recombinant])

CHU de Québec – Université Laval (2022-02-18)

COVB-2022-1 (Control # 261144) Authorized under the Clinical Trials Interim Order

Covid-19 Vaccine Booster in Immunocompromised Rheumatic Diseases (COVBIRD)

NCT05236491

Phase 2/3

Recruiting

Estimated start date: 2022, March 9

Estimated study completion date: 2023, January

Experimental: Moderna mRNA vaccine (Spikevax) 0.5mL IM (one dose)

Experimental: AstraZeneca Vaxzevria vaccine 0.5mL IM (one dose)

Experimental: Novavax NVX-CoV2373 vaccine (Novaxovid) (one dose)

18+, diagnosed systemic autoimmune rheumatic disease, triple vaccinated

287 participants

No results posted

Vaccine: TAP-COVID-19

Kentucky Bioprocessing, Inc. (2021-05-03)

KBP-201 (Control #251755) Authorized under the clinical trials interim order

A phase I/II, first-in-human, observer-blinded, randomized, placebo-controlled, parallel group study to evaluate the safety and immunogenicity of TAP-COVID-19 SARS-CoV-2 vaccine with CpG adjuvant in healthy seronegative adults aged 18-49 and 50-85

NCT04473690

Phase 1/2

Completed

Start Date: 2020, October 14

Estimated completion date: 2022, December 31

Experimental: Low dose KBP-COVID-19 and adjuvant

Experimental: High dose KBP-COVID-19 and adjuvant

Placebo Comparator: Buffered saline solution

Adult 18-85 years, healthy

101 participants

No results posted

Vaccine: Tozinemeran (Pfizer-BioNTech COVID-19 Vaccine) / mRNA-1273 SARS-CoV-2 vaccine (COVID-19 Vaccine Moderna) / ChAdOx1-S [recombinant] (AstraZeneca COVID-19 Vaccine)

Dalhousie University/Canadian Immunization Research Network (CIRN) (2021-05-05)

CT24 (Control #251972) Authorized under the clinical trials interim order )

Immunogenicity and adverse events following immunization with alternate schedules of authorized COVID-19 vaccines in Canada: MOSAIC study (Mix and match of second COVID-19 vaccine dose for safety and immunogenicity)

NCT04894435

Phase 2

Recruiting

Start date: 2021, May 20

Estimated study completion date: 2023, March

Experimental: (Moderna, Moderna 28 days apart) mRNA-1273 SARS-CoV-2 vaccine 0.2mg/ml IM in deltoid muscle two doses 28 days apart

Experimental: (Moderna, Moderna 112 days apart) mRNA-1273 SARS-CoV-2 vaccine 0.2mg/ml IM in deltoid muscle two doses 112 days apart

Experimental: (Moderna, Pfizer/BioNTech 28 days apart) mRNA-1273 SARS-CoV-2 vaccine 0.2mg/ml IM in deltoid muscle followed by one dose (0.3mL) of BNT162b2 vaccine 28 days apart

Experimental: (Moderna, Pfizer/BioNTech 112 days apart) mRNA-1273 SARS-CoV-2 vaccine 0.2mg/ml IM in deltoid muscle followed by one dose (0.3mL) of BNT162b2 vaccine 112 days apart

Experimental: (Pfizer/BioNTech, Pfizer/BioNTech 28 days apart) BNT162b2 vaccine 0.3mL IM in deltoid muscle two doses 28 days apart

Experimental: (Pfizer/BioNTech, Pfizer/BioNTech 112 days apart) BNT162b2 vaccine 0.3mL IM in deltoid muscle two doses 112 days apart

Experimental: (Pfizer/BioNTech, Moderna 28 days apart) BNT162b2 0.3mL IM in deltoid muscle followed by mRNA-1273 SARS-CoV-2 0.2mg/ml 28 days apart

Experimental: (Pfizer/BioNTech, Moderna 112 days apart) BNT162b2 0.3mL IM in deltoid muscle followed by mRNA-1273 SARS-CoV-2 0.2mg/ml 112 days apart

Experimental: (AstraZeneca, AstraZenaca 112 days apart) ChAdOx1-S 0.5mL IM in deltoid muscle two doses 112 days apart

Experimental: (AstraZeneca, Moderna 28 days apart) ChAdOx1-S 0.5mL IM in deltoid muscle followed by mRNA-1273 SARS-CoV-2 0.2mg/mL 28 days apart

Experimental: (AstraZeneca, Moderna 112 days apart) ChAdOx1-S 0.5mL IM in deltoid muscle followed by mRNA-1273 SARS-CoV-2 0.2mg/mL 112 days apart

Experimental: (AstraZeneca, Pfizer/BioNTech 28 days apart) ChAdOx1-S 0.5mL IM in deltoid muscle followed by BNT162b2 0.3mL 28 days apart

Experimental: (AstraZeneca, Pfizer/BioNTech 112 days apart) ChAdOx1-S 0.5mL IM in deltoid muscle followed by BNT162b2 0.3mL 112 days apart

18-99 years, Healthy or stable co-morbidities

1200 participants

No results posted

Vaccine: VBI-2902a

VBI Vaccines Inc. (2020-12-18)

VBI-2902a-CT01 (Control #246985) Authorized under the clinical trials interim order

A Phase 1/2, randomized, observer-blind, dose-escalation, placebo-controlled study to evaluate the safety, tolerability, and immunogenicity of the COVID-19 (SARS-CoV-2) vaccine candidate (VBI-2902a) in healthy adults

NCT04773665

Phase 1

Completed

Study start date: 2021, March 15

Estimated study completion date: 2022, November 14

Experimental: VBI-2902a (enveloped virus-like particle with aluminum phosphate adjuvant) with 5microg of S protein IM injection one dose + placebo 28 days later

Experimental: VBI-2902a (enveloped virus-like particle with aluminum phosphate adjuvant) with 5microg of S protein IM injection two doses 28 days apart

Placebo comparator: 0.9% sodium chloride (normal saline) IM injection two doses 28 days apart

Experimental: VBI-2902a (enveloped virus-like particle with aluminum phosphate adjuvant) with 10microg of S protein IM injection one dose + placebo 28 days later

Experimental: VBI-2902a (enveloped virus-like particle with aluminum phosphate adjuvant) with 10microg of S protein IM injection two doses 28 days apart

Adult (18+), healthy

114 participants

No results yet posted

Vaccine: VBI-2902a

Variation Biotechnologies Inc. (2022-09-15)

VBI-2901A (Control # 267517) Authorized under the Clinical Trials for Medical Devices and Drugs Relating to COVID-19 Regulations

A Phase 1, Randomized Study To Evaluate The Safety And Immunogenicity Of VBI- 2901a, A Trivalent Coronavirus Vaccine Candidate In Healthy Adults Previously Vaccinated With Licensed Covid-19 Vaccines

NCT05548439

Phase 1

Active, not recruiting

Start date: October 5, 2022

Estimated Completion date: 2024, February

Experimental arm: VBI-2901a 5 µg IM at Day 1 and Day 56

Experimental arm: VBI-2901a 10 µg IM at Day 1 and Day 56

Experimental arm: VBI-2901a 10 µg IM at Day 1

18-64 years, healthy, previously received two or more doses of COVID-19 vaccine(s)

103 participants

No results yet posted

Vaccine:VBI-2901E

Variation Biotechnologies Inc. (2022-10-25)

VBI-2901E (Control # 268572) Authorized under the Clinical Trials for Medical Devices and Drugs Relating to COVID-19 Regulations

A Phase 1, Open-Label, Adjuvant Dose-Escalation, Randomized Study To Evaluate The Safety And Immunogenicity Of Vbi-2901e, A Trivalent Coronavirus Vaccine Candidate Adjuvanted With Aluminum Phosphate And E6020 In Healthy Adults Previously Vaccinated With Licensed Covid-19 Vaccines

NCT05614245

Phase 1

Not yet recruiting

Start date: 2023, March (estimated)

Estimated Completion date: 2024, June

Experimental: VBI-2901e 5 µg and 1 µg E6020 IM, one dose

Experimental: VBI-2901e 5 µg and 1 µg E6020 IM at Day 1 and Day 28

Experimental: VBI-2901e 5 µg and 3 µg E6020 IM, one dose

Experimental: VBI-2901e 5 µg and 3 µg E6020 IM at Day 1 and Day 28

Experimental: VBI-2901e 5 µg and 1 µg E6020 IM, one dose

Experimental: VBI-2901e 5 µg and 10 µg E6020 IM at Day 1 and Day 28

18-40 years, healthy, received two or more doses of COVID-19 vaccine(s)

60 participants

No results yet posted