Drugs and vaccines for COVID-19: List of authorized clinical trials
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 | Treatment: hydroxychloroquine | St. Joseph's Health Care Parkwood site | 2020-05-09 | N/A |
| 20-5449 (Control #239579) |
Use of High Dose Inhaled Nitric Oxide in Intubated Patients Admitted with COVID-19 | Treatment: nitric oxide | University Health Network | 2020-06-25 | NCT04383002 |
| 2149 Control # 240138 Authorized under Clinical Trials Interim Order |
Sedating with 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 | Treatment: isoflurane, sevoflurane | Sunnybrook Health Sciences Centre | 2020-06-10 | NCT04415060 |
| 776228483 PROACTIVE (Control # 240296) |
Propranolol as an anxiolytic to reduce the use of sedatives for critically ill adults receiving mechanical ventilation: an open-label randomized controlled trial. (PROACTIVE) | Treatment: propranolol | Ottawa Hospital Research Institute | 2020-06-10 | N/A |
| 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) | Treatment: 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 from 18 to <85 years of age in Canada | Vaccine: 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. | Treatment: NP-120 (Ifenprodil) | Algernon Pharmaceuticals | 2020-04-29 | N/A |
| 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? | Losartan | Providence Health Care Saint Paul's Hospital | 2020-09-28 | N/A |
| BAI_COV19_01 (Control #239071) |
Inhaled NO for the treatment of COVID-19 caused by SARS-CoV-2 | Treatment: 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 | Treatment: ribavirin (Virazole®) | Valeant Canada LP/Valeant Canada S.E.C. | 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. |
Treatment: remdesivir, interferon beta-1a | Sunnybrook Research Institute | 2020-03-18 | NCT04330690 |
| CINC424J12301 RUXCOVID (Control # 240395) |
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) | Treatment: Jakavi (ruxolitinib) | Novartis Pharmaceuticals Canada Inc. | 2020-06-16 | NCT04362137 |
| CIRCA-19 (Control # 238608) |
Cellular Immunotherapy for COVID-19 acute respiratory distress syndrome (ARDS) | Treatment: (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 (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 | Vaccine: Recombinant Mycobacterium bovis BCGΔureC::hly |
Princess Margaret Cancer Centre | 2020-05-08 | N/A |
| COLCORONA MHIPS-2020-001 (Control # 237317) |
Colchicine coronavirus SARS-COV2 trial (COLCORONA) | Treatment: 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 | Treatment: 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 | Treatment: favipiravir | Appili Therapeutics Inc. | 2020-05-18 | N/A |
| CORIPREV-1 (Control # 237350) |
COVID-19 Ring-Based Prevention Trial with lopinavir/ritonavir (CORIPREV-LR). | Treatment: lopinavir/ ritonavir | Unity Health Toronto | 2020-03-21 | NCT04321174 |
| 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. | Treatment: Actemra®/RoActemra® (tocilizumab) |
Hoffmann-La Roche Limited | 2020-03-25 | 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 | Treatment: nitric oxide | Sanotize Research & Development Corp. | 2020-04-18 | NCT04337918 |
| 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 | Treatment: nitric oxide | Sanotize Research & Development Corp. | 2020-06-30 | 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) | Treatment: hydroxychloroquine | Research Institute of the McGill University Health Centre | 2020-03-25 | NCT04308668v |
| 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 | Vaccine: Coronavirus-like Particle (CoVLP) COVID-19 Vaccine | Medicago Inc. | 2020-07-09 | N/A |
| CTSN-MSC-ARDS001 (Control #241138) |
Mesenchymal Stem Cells for the Treatment of Moderate to Severe COVID-19 Acute Respiratory Distress Syndrome | Treatment: Remestemcel-L | Mesoblast, Inc. | 2020-07-31 | N/A |
| 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 dapagliflozin in respiratory failure in patients with COVID-19 | Treatment: DAPAGLIFLOZIN | Saint Luke's Hospital of Kansas City | 2020-07-04 | N/A |
| DISCONNECT-1 CTA Control # 241689 |
DISmantling 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 | Treatment: Pulmozyme (Dornase Alfa) | The Research Institute of the McGill University Health Centre | 2020-07-24 | NCT04409925 |
| 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 | Treatment: EB05 | Edesa Biotech Research Incorporated | 2020-06-12 | N/A |
| EXTENDED-P2 (Control # 240041) |
EXTENDED (Novel O Therapeutic NaN02 for COVID-19 induced ARDS) Phase IIa Trial | Treatment: perflenapent (NaNO2) | Research Institute of the McGill University Health Centre | 2020-06-10 | N/A |
| GRAAL-2020-01 (Control # 238201) |
A Randomized, Open-Label Trial of CONvalescent Plasma for Hospitalized Adults With Acute COVID-19 Respiratory Illness (CONCOR-1) | Treatment: 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 | Treatment: 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 | Treatment: hydroxychloroquine | University Health Network | 2020-04-03 | NCT04374942 |
| 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) | Treatment: hydroxychloroquine | University of Calgary | 2020-04-09 | NCT04329611 |
| 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 | Vaccine: IMM-101 | Canadian Cancer Trials Group, Cancer Research Institute, Queen's University | 2020-06-24 | NCT04442048 |
| 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 | Treatment: 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 | Treatment: LAU-7B (Fenretinide) | Laurent Pharmaceuticals | 2020-05-02 | N/A |
| LESSCOVID (Control #238851) |
Exogenous Surfactant Administration for Patients with COVID-19 | Treatment: BLES (bovine lipid extract surfactant suspension) | St. Joseph's Health Centre London | 2020-05-05 | NCT04375735 |
| LOVIT-COVID MP-31-2021-3741 (Control #239705) |
Lessening Organ Dysfunction with VITamin C - COVID (LOVITCOVID) | Treatment: Vitamin C | Centre de recherche du centre hospitalier universitaire de Sherbrooke | 2020-06-05 | NCT04401150 |
| Mild-CONTAIN 2021-6638 (Control # 239123) |
Mild - CONTAIN CiclesOnide cliNical TriAl covId-19 treatmeNt | 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) | Treatment: 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 | Treatment: hydroxychloroquine | Research Institute of the McGill University Health Centre | 2020-05-04 | N/A |
| MUHC_CAMOSTAT MESILATE (Control #240313) |
The impact of the Camostat Mesilate on COVID-19 Infection: A Randomized Controlled Phase II Clinical Trial | Treatment: CAMOSTAT | McGill University Health Centre | 2020-07-02 | N/A |
| 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) | Treatment: Ozanimod | Institut universitaire de cardiologie et de pneumologie de Québec | 2020-07-13 | NCT04405102 |
| NTM-CTP-01 (Control # 236728) |
An Open Label Safety Study of Inhaled Gaseous Nitric Oxide (gNO) for Adults & Adolescents with Non-Tuberculous Mycobacteria | Treatment: nitric oxide | Dr. Jeremy Road | 2020-03-19 | NCT03331445 |
| ONV2020-003 CTA Control# 243886 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 | Hiltonol (Polyriboinosinic acid-polyribocytidylic acid (Poly-ICLC)) | Oncovir, Inc. | 2020-09-25 | N/A |
| OZM-113 (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 | Treatment: Innohep (Tinzaparin sodium) / Lovenox (enoxaparin sodium) / Fragmin (dalteparin sodium) / Heparin Sodium | University of Manitoba | 2020-04-29 | N/A |
| PDC01 (Control #242430) |
A randomized, placebo-controlled, multicenter study to assess the safety & efficacy of dapsone on the treatment of COVID-19 positive patients | Treatment: dapsone | Research Institute of the McGill University Health Centre | 2020-08-20 | N/A |
| PHRI.ACT.COVID19 (Control # 238157) |
Anti-Coronavirus Therapies to Prevent Progression of COVID-19 (ACT), a Randomized Trial | Treatment: colchicine / acetylsalicylic acid / rivaroxaban / interferon beta-1b | Hamilton Health Sciences | 2020-04-18 | NCT04324463 |
| PREP2020 (Control #238396) |
Pre-Exposure Prophylaxis fro SARS-Coronovirus-2: A Pragmatic Randomized Clinical Trial | Treatment: hydroxychloroquine | University of Manitoba | 2020-04-21 | N/A |
| PRO00100606 (Control # 240943) |
Improving vitamin D status in the management of COVID-19 | Treatment: Vitamin D | Governors of the University of Alberta | 2020-07-27 | NCT04385940 |
| 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 | Treatment: GSK3196165 (Otilimab), monoclonal antibody | GlaxoSmithKline | 2020-05-27 | 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) | Treatment: Fondaparinux / Innohep / Fragmin / Lovenox / Lovenox HP / Heparin sodium injection / Heparin sodium and 0.9% sodium chloride injection / Heparin sodium in 5% dextrose injection | Unity Health Toronto | 2020-04-24 | 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 | Treatment: Actemra (Tocilizumab) | University of Calgary | 2020-05-22 | 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 |
Treatment: Lopinavir/Ritonavir, Interferon beta-1a, apo-Hydroxyquine Heparin Sodium, Lovenox, Fragmin, Innohep, Aphresis frozen plasma from recovered COVID-19 patients (Convalescent Plasma), Kineret, Vitamin C |
Unity Health Toronto | 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) | Treatment: Baricitinib |
Dr. Lisa Barrett | 2020-04-14 | NCT04321993 |
| 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 | Treatment: Kevzara® (sarilumab) | Sanofi-Aventis Canada Inc. | 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 | Treatment: Ruxolitinib, placenta derived decidual stromal cells (DSC) | University Health Network | 2020-04-07 | NCT04331665 |
| UHNSEMPATICO1 Control# 244389 |
Semaglutide to reduce Myocardial injury in PATIents with COVID-19 | Ozempic (Semaglutide) | University Health Network | 2020-10-07 | N/A |
| 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 | Treatment: icosapent (Vascepa™) | Canadian Medical and Surgical Knowledge Translation Research | 2020-05-08 | N/A |
| 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 | VIR-7831 | Vir Biotechnology, Inc. | 2020-10-13 | NCT04545060 |
| OHRI-HBOT-001 (Control #242108) |
Multicentre Randomized Controlled Trial of Hyperbaric versus Normobaric oxygen therapy for COVID-19 Patients | Treatment: Oxygen | Ottawa Hospital Research Institute | 2020-07-30 | N/A |
| COV-01 Control # 242568 Authorized Under 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 | Treatment: Taltz (Ixekizumab) / Otezla (Apremilast tablets) | Amgen Canada Inc. | 2020-08-20 | N/A |
PROTECT (Control # 243196) |
Prevention of COVID-19 with Oral Vitamin D Supplemental Therapy in Essential Healthcare Teams | Treatment: Cholecalciferol | Centre Hospitalier Universitaire Sainte-Justine | 2020-09-16 | NCT04483635 |
| 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 | Treatment: recombinant human alkaline phosphatase | AM-PHARM A B.V. | 2020-09-11 | NCT04411472 |
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. | MK-4482 | Merck Canada Inc. | 2020-10-19 | NCT04575597 |
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. | MK-4482 | Merck Canada Inc. | 2020-10-19 | NCT04575584 |
CTO-3212 Control# 244591 Filed under the IO |
Evaluation of The Potential Benefit of Reninangioten Sin System Inhibitors (RASI, ACEI/ARB) in High-Risk Patients with COVID-19 | Cadesartan / Valsartan / Ramipril / Perindopril / Irbesartan / Losartan / Enalapril / Captopril | Ottawa Heart Institute Research Corporation | 2020-10-16 | NCT04591210 |
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 | ProTrans (Wharton’s Jelly derived Umbilical Cord Mesenchymal Stromal Cells (UCMSC) | Research Institute of the McGill University Health Centre | 2020-10-16 | N/A |
FAST-1 |
Nebulized Furosemide For Pulmonary Inflammation in Intubated Patients with COVID-19 - A Phase 2/3 Study | Furosemide | Kingston Health Science Centre | 2020-10-13 | NCT04588792 |
Report a problem or mistake on this page
- Date modified: