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Health Canada authorized clinical trials for COVID-19 drugs and vaccines 


Intervention

Authorization holder (Authorization date)

Trial name (Health Canada Control #)

Title

Trial registry identifier

Phase

Recruitment status

Start date

Estimated study completion date

Arms and Treatments

Population

Estimated enrollment

Results

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

Recruiting

Start Date: 2020, May 15

Estimated study completion date: 2021, June

(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

No results posted

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

NCT04400032

Phase 1/2

Recruiting

Start Date: 2020, May 15

Estimated study completion date: 2021, June

Experimental: UC-MSCs 75 million cells IV

Experimental: UC-MSCs 150 million cells IV

Experimental: UC-MSCs 270 million cells IV

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

21 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)

Phase 2

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

Recruiting

Start date:2020, October 7

Estimated study completion date:

2022, May 1

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

No Intervention: Clinical standard of care

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

100 participants

No results posted

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

Active, not recruiting

Start Date:2020, May 14

Estimated study completion date: 2021, March 31

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

1200 participants

No results posted

Baricitinib

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: 2022 March

Experimental: Baricitinib (janus kinase inhibitor) 2mg po daily for 10 days

No Intervention: Clinical standard of care

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

800 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

Not yet recruiting

Start Date: 2020, July 1 (estimated)

Estimated study completion date: 2021, July 1

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

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: 2022, August

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

Carbon-Dioxide 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

Not yet recruiting

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

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

Not yet recruiting

Start date: 2021, April (estimated)

Estimated primary completion date: 2021, 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

Recruiting

Start Date: 2021, February 8)

Estimated study completion date: 2021, December 31

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

2414 participants

No results reported

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

Recruiting

Start Date:2020, September 14

Estimated study completion date: 2021, March 25

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

454 participants

No results posted

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: 2021, January 21

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)

4506 participants (actual)

No results posted

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: 2021, June 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

No results posted

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

Recruiting

Start date: 2021, February 25

Estimated study completion date: 2022, January 30

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

Placebo comparator: Placebo

18+, hospitalized for COVID-19

1000 participants

No results posted

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

Recruiting

Start date: 2021, January 11

Estimated study completion date: 2021, May

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

Not yet posted

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

Active, not recruiting

Start Date:2020, April 22

Estimated study completion date: 2021, June

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)

No results posted

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)

Phase 3

Not yet recruiting

Experimental: Dapsone PO for 21 days

Experimental: Generic anti-inflammatory drug PO for 21 days

Placebo comparator: Placebo PO for 21 days

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

2100 participants

No results yet posted

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

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

Recruiting

Start Date:2020, October 16

Estimated study completion date: 2021, March

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

760 participants

No results posted

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

Recruiting

Start Date:2020, June 29

Estimated study completion date: 2021, May 30

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

Placebo Comparator: Placebo PO QD for up to 14days

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)

240 participants

No results 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

Recruiting

Start date: 2020, December 22

Estimated completion date: 2021, September

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

1100 particpants

Not yet posted

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

Recruiting

Start Date: 2020, May 11

Estimated study completion date: 2022, April

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

No results posted

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: 2020, December 11 (estimated)

Estimated study completion date: 2021, October 1

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

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

Recruiting

Start Date: 2020, May 28

Estimated study completion date: 2021, August 23

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)

1150 participants

No results posted

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

Not yet recruiting

Start date: 2020, May 19 (estimated)

Estimated study completion date:

2021, April 30

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

No results posted

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

Enrolling by invitation

Start Date:2020, April 30

Estimated study completion date:

2022, January 30

Experimental: Hydroxychloroquine 400mg QD for 3 months

Placebo Comparator: Placebo QD for 3 months

Adult, health care worker in the emergency department 

988 participants

No results posted

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

Study completion date: 2020, July 20

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)

Study Suspended

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

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

Recruiting

Start date: 2020, June 4

Estimated study completion date: 2020, December

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

No results posted

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

Active, not recruiting

Start Date: 2020, May 20

Estimated study completion date: 2021, January

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), 3rd 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

1203 participants (actual)

No results posted

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

Recruiting

Start Date: 2020, August 5

Estimated study completion date:

2022, February

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,

682 participants

No results posted

Ixekizumab (Taltz)/ Apremilast tablets (Otezla)

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

Recruiting

Start Date: 2020, November 24

Estimated study completion date: 2021, September 20

Experimental: Apremilast PO

Placebo comparator: Matching placebo PO

Adult (18+), COVID-19, Hospitalized

700 participants

No results posted

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

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

1220 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?

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

Not yet 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

No results yet posted

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

NCT04575597

Phase 2/3

Recruiting

Start Date: 2020, October 19

Estimated study completion date: 2021, October 14

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

1450 participants

No results posted

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

NCT04575584

Phase 2/3

Recruiting

Start Date: 2020, October 19

Estimated study completion date: 2021, October 18

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

1300 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

Recruiting

Start Date: 2020, September 2

Estimated study completion date: 2021, August

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

Recruiting

Start Date: 2020, June 13

Estimated study completion 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)

20 participants

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)

No results posted

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

Not yet recruiting

Start Date: 2020, September (estimated)

Estimated study completion date: 2021, July

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

Placebo Comparator: Placebo

Adult, mild COVID-19 no flu-like symptoms

50 participants

No results posted

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

Recruiting

Start Date: 2017, October 21

Estimated study completion date: 2021, March 31

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

20 participants

Results not posted

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

Not yet recruiting

Study start date: 2021, February (estimated)

Estimate study completion date: 2022, January

Experimental: Omalizumab single subcutaneous dose 375mg

Placebo comparator: Normal saline single subcutaneous dose

18+, SARS-CoV-2 positive, hospitalized

200 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)

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

Recruiting

Start Date: 2020, September 16

Estimated study completion date: 2024, January 1

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

48 participants

No results posted

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

Phase 3

Experimental:

Placebo comparator:

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

Phase 2

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

Not yet recruiting

Start date: 2021, April 1 (estimated)

Estimated study completion date: 2024, January 16

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

Not yet recruiting

Start date: 2021, April (estimated)

Estimated study completion date: 2022, August

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

1526 participants

No results posted

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

Recruiting

Start Date: 2020, December 11

Estimated study completion date: 2021, May

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

108 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

Phase 2

Not yet recruiting

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

Recruiting

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

Not yet recruiting

Start Date: 2020, October 15 (estimated)

Estimated study completion date: 2024, February 15

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

Placebo comparator: matching placebo

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

1400 participants

Not yet posted

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

Not yet recruiting

Start date: 2021, March (estimated)

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: 2022, 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

Recruiting

Start Date: 2020, April 30

Estimated study completion date: 2022, April

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

300 participants

No results posted

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

Not yet recruiting

Start Date: 2021, April (estimated)

Estimated study completion date: 2021, August

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

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

Adult, COVID-19, hospitalized

50 participants

No results yet posted

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, placenta derived decidual stromal cells (DSC)

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

Not yet recruiting

Start Date: 2020, April 20 (estimated)

Estimated study completion date: 2021, January 31

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

64 participants

No results posted

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

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

Not yet recruiting

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

Recruiting

Start Date: 2020, August 14

Estimated study completion date: 2022, January

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

No results posted

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)

NCT04385940

Phase 3

Recruiting

Start Date: 2018, November 8

Estimated study completion date: 2022, December 31

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

800 participants

No results posted

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

Not yet recruiting

Start Date: 2020, June (estimated)

Estimated study completion date: 2020, December

Experimental: Vitamin D3 50 000 IU PO

Active Comparator: Vitamin D3 1000 IU PO

17 years +, COVID-19

64 participants

No results posted

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

NTC04545060

Phase 2/3

Active, not recruiting

Start date: 2020, August 27

Estimated study completion date: 2021, July

Experimental: VIR-7831 IV infusion

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

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

1360 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

Recruiting

Study start date: 2021, February 18

Estimated study completion date: 2021, September

Experimental: VIR-7831 (Gen2) IV

Active comparator: VIR-7831 (Gen1) IV

18+, SARS-CoV-2 positive, outpatient

40 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

Recruiting

Start date: 2020, August 28

Estimated study completion date: 2021, December 15

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

1210 participants

No results posted

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

Not yet recruiting

Start date: March 12, 2021 (estimated)

Estimated study completion date: June 20, 2023

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

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

400 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

Active, not recruiting

Start Date: 2020, July 10

Estimated study completion date: 2021, December 31

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

No results posted

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

Recruiting

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

30612

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 1/2

Recruiting

Study start date: 2021, January (estimated)

Estimated study completion date: 2023, February

Experimental: COVAC-2 25microg IM injection two doses 28 days apart

Placebo comparator: Saline IM injection two doses 28 days apart

Experimental: COVAC-2 50microg IM injection two doses 28 days apart

Experimental: COVAC-2 100microg IM injection two doses 28 days apart

Healthy adults (18+)

108 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

Not yet recruiting

Study start date: 2021, March (estimated)

Estimated study completion date: 2022, August

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

Placebo comparator: placebo injection

18-84 years, healthy

72 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

Recruiting

Start Date:

2020, June 25

Estimated primary completion date:

2020, December 31

Estimated study completion date:

2021, March 31

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

1500 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

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: 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

Recruiting

Start Date:2020, June 24

Estimated study completion date: 2021, July 1

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

3626 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

Not yet recruiting

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

No results yet 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 1/2

Active, Not recruiting

Study start date: 2021, March 15

Estimated study completion date: 2022, June

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

780 participants

No results yet posted

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Canadian Society of Pharmacology and Therapeutics (CSPT)

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