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
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