Drugs and vaccines for COVID-19: List of authorized clinical trials

Currently, the treatment of COVID-19 includes providing supportive care and treating secondary infections, such as pneumonia. As yet, no drugs or vaccines have been authorized to prevent, treat or cure COVID-19 in Canada.

The table below lists the COVID-19 drugs, including vaccines, currently being investigated in clinical trials authorized by Health Canada. Authorization is through the Food and Drug Regulations or the interim order for clinical trials for medical devices and drugs related to COVID-19.

Health Canada continues to discuss potential clinical trials with a number of sponsors. We will update the list as new trials related to drugs or vaccines for COVID-19 are authorized.

Trial Name /Protocol #/control # Title Interventions Authorization holder Authorization date Clinicaltrials.gov Link
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 hydroxychloroquine St. Joseph's Health Care Parkwood site 2020-05-09 N/A
(COVID19 PEP RCT - Canada)
2020-6549
(Control # 237355)
Post-exposure Prophylaxis or Preemptive Therapy for SARS-Coronavirus-2: A Pragmatic Randomized Clinical Trial (COVID19 PEP RCT - Canada) hydroxychloroquine Research Institute of the McGill University Health Centre 2020-03-25 NCT04308668v
AB002
(Control #238815)

Multicentre, 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)

LSALT Peptide Arch Biopartners Inc. 2020-05-07 N/A
Ad5-nCoV-2020003
Control # 239283
A Randomized, Observer-Blind, Dose-escalation Phase I/II Clinical Trial of Ad5-nCoV Vaccine in Healthy Adults in Canada Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5) (Ad5-nCoV) CanSino Biologics Inc. 2020-05-15 N/A
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. NP-120 (Ifenprodil) Algernon Pharmaceuticals 2020-04-29 N/A
BAI_COV19_01
Control #239071
Inhaled NO for the treatment of COVID-19 caused by SARS-CoV-2 Nitric oxide Beyond Air. Inc. 2020-05-19 N/A
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 ribavirin (Virazole®) Valeant Canada Inc 2020-04-08 NCT04356677
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.

lopinavir/ ritonavir
Remdesivir
hydroxychloroquine
Sunnybrook Research Institute 2020-03-18 NCT04330690
CIRCA-19
(Control # 238608)
Cellular Immunotherapy for COVID-19 acute respiratory distress syndrome (ARDS) (1) Allogeneic Bone Marrow Mesenchymal Stromal Cells (BM-MSCs) / (2) Allogeneic Umbilical Cord Mesenchymal Stromal Cells (UC-MSC) Ottawa Hospital Research Institute 2020-05-15 N/A
COBRA
(CTA 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 Recombinant
Mycobacterium bovis

BCGΔureC::hly
University Health Network - Princess Margaret Cancer Centre 2020-05-08 N/A
COLCORONA
(MHIPS-2020-001)
(Control # 237317)
Colchicine coronavirus SARS-COV2 trial (COLCORONA) colchicine Montreal Heart Institute 2020-03-20 NCT04322682
CONCOR-Kids
(Control # 238820)
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 Apheresis frozen plasma from recovered COVID-19 patients (Convalescent Plasma) C17 Council 2020-05-04 N/A
CONTROL-COVID-Favipiravir-1
Control #239133
Control of COVID-19 outbreak in long term care Hydroxychloroquine favipiravir Appili Therapeutics Inc. 2020-05-18 N/A
CORIPREV-1
(Control # 237350)
COVID-19 Ring-Based Prevention Trial with lopinavir/ritonavir (CORIPREV-LR). lopinavir/ ritonavir Unity Health Toronto 2020-03-21 NCT04321174
COVACTA
(Control #: 237397)
A randomised, double-blind, placebo-controlled Phase III clinical) to evaluate the safety and efficacy of Actemra®/RoActemra®(tocilizumab) plus standard of care in hospitalised adult patients with severe COVID-19 pneumonia compared to placebo plus standard of care. Actemra®/RoActemra®
(tocilizumab)
Hoffmann-La Roche Limited 2020-03-24 NCT04320615
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 nitric oxide Sanotize Research & Development Corp. 2020-04-18 NCT04337918
GRAAL-2020-01
(Control # 238201)
A Randomized, Open-Label Trial of CONvalescent Plasma for Hospitalized Adults With Acute COVID-19 Respiratory Illness (CONCOR-1) Apheresis frozen plasma from recovered COVID-19 patients (Convalescent Plasma) Hamilton Health Sciences 2020-04-16 NCT04348656
GS-US-540-5821
(Control # 238163)
Expanded Access Treatment Protocol: Remdesivir (RDV; GS-5734) for the Treatment of SARS-COV2 (COV) Infection remdesivir Gilead Sciences Canada Inc. 2020-04-15 NCT04323761
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 hydroxychloroquine University Health Network 2020-04-03 NCT04333732
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 (Short title: ALBERTA HOPE COVID-19) hydroxychloroquine University of Calgary 2020-04-09 NCT04329611
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 Peginterferon Lambda-1A University Health Network 2020-04-29 N/A
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 LAU-7B (Fenretinide) Laurent Pharmaceuticals 2020-05-02 N/A
LESSCOVID
(Control #238851)

Exogenous Surfactant Administration for Patients with COVID-19

BLES (bovine lipid extract surfactant suspension)

St. Joseph's Hospital 2020-05-02 NCT04375735
Mild-CONTAIN
2021-6638
Control # 239123
Mild - CONTAIN CiclesOnide cliNical TriAl covId-19 treatmeNt Ciclesonide Research Institute of the McGill University Health Centre 2020-05-23 N/A
MP-31-2019-2945
(Control # 237164)
Lessening Organ Dysfunction with Vitamin C (LOVIT) Vitamin C
(ascorbic acid)
Centre de recherche du centre hospitalier universitaire de Sherbrooke 2020-03-18 NCT03680274
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 Research Institute of the McGill University Health Centre 2020-05-02 N/A
NTM-CTP-01
(Control # 236728)

An Open Label Safety Study of Inhaled Gaseous Nitric Oxide (gNO) for Adults & Adolescents with Non-Tuberculous Mycobacteria

nitric oxide Dr. Jeremy Road 2020-03-19 NCT03331445
OZM-113 (CTA Control # 238691) Therapeutic-dose anti-coagulation for the treatment of hospitalized patients with COVID-19: the antthrombotic therapy to ameliorate complications of COVID01 (ATTACC) trial Innohep (Tinzaparin sodium) / Lovenox (enoxaparin sodium) / Fragmin (dalteparin sodium) / Heparin Sodium University of Manitoba 2020-04-29 N/A
PHRI.ACT.COVID19
(Control # 238157)
Anti-Coronavirus Therapies to Prevent Progression of COVID-19 (ACT), a Randomized Trial

chloroquine hydroxychloroquine azithromycin

interferon beta-1b (Betaseron®)

Hamilton Health Sciences 2020-04-18 NCT04324463
PREP2020
(Control #238396)
Pre-Exposure Prophylaxis fro SARS-Coronovirus-2: A Pragmatic Randomized Clinical Trial hydroxychloroquine University of Manitoba 2020-04-21 N/A
RAPID COVID COAG
(Control #238510)

Coagulopathy of COVID-19: A pragmatic randomized controlled trial of therapeutic anticoagulation versus standard care as a rapid response to the COVID-19 pandemic (RAPID COVID COAG) fondaparinux heparin, dalteparin, enoxaparin and tinzaparin Unity Health Toronto 2020-04-24 N/A
REMAP-CAP
(X17-0199
(Control # 237719)
Randomized, Embedded, Multifactorial Adaptive Platform trial for Community-Acquired Pneumonia (REMAP-CAP):
PANDEMIC APPENDIX TO THE CORE PROTOCOL

Heparin Sodium (unfractionated heparin), Lovenox (enoxaparin sodium), Fragmin (dalteparin sodium), Innohep (tinzaparin sodium),

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

Anakinra
St-Michael's Hospital Unity Health 2020-04-01 NCT02735707
SAIL-004
(Control # 237708)
Assessment of Investigational Medications adjunct to Clinical Standard of Care for Treatment of Moderate to Severe Coronavirus Disease (COVID-19) lopinavir/ritonavir hydroxychloroquine sarilumab
baricitinib
Dr. Lisa Barrett 2020-04-14 NCT04321993
SAR153191
(Control # 237332)
The multi-center, double-blind, Phase 2/3 trial has an adaptive design phase 2/3 CT proposed for affected patients with serious lung inflammation treatment Kevzara®. Kevzara® (sarilumab) Sanofi-Aventis Recherche & Développement 2020-03-24 NCT04315298
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 ruxolitinib University Health Network 2020-04-07 NCT04331665
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

icosapent (Vascepa™) Canadian Medical and Surgical Knowledge Translation Research 2020-05-08 N/A
REB20-0713
(CTA Control # 239287)

A prospective, observational 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-Cov2 positive patients

Actemra (Tocilizumab) University of Calgary 2020-05-22 N/A
Protocol 214094
(Control # 239770)
A randomized, double-blind, placebo-controlled, study evaluating the efficacy and safety of otilimab IV in patients with severe pulmonary COVID-19 related disease GSK3196165 (Otilimab), monoclonal antibody GlaxoSmithKline 2020-05-27 N/A
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