Conducting a clinical trial for COVID-19 medical devices: List of authorized clinical trials

The table below lists the clinical trials authorized by Health Canada for COVID-19-related medical devices. Authorization is done through the Medical Device Regulations or the New Clinical Trials for Medical Devices and Drugs Relating to COVID-19 Regulations, that replaced the Interim order on February 27, 2022.

Health Canada continues to discuss potential clinical trials with a number of sponsors. We will update the list as new trials related to medical devices are authorized.

Trial Name /Protocol #/control # Title Medical device name Authorization holder Authorization date Clinicaltrials.gov Link
ITA #357822 A pilot cross-sectional study evaluating long-term effect of COVID-19 related Acute Respiratory Distress Syndrome (ARDS) on cognition and cerebral vascular reactivity Respiract RA-MR Thornhill Research Inc. 2023-02-23 N/A
ITA #342924
Authorized under the Clinical Trials COVID-19 Regulations
Clinical Evaluation of the Sona Saliva C-19 Rapid Self-Test Sona Saliva C-19 Rapid Self-Test Sona Nanotech Inc. 2022-04-05 NCT05256589
ITA #348963 Lung Structure-Function In SurVivors of Mild and SEvere COVID-19 Infection: 129Xe MRI and CT For Rapid Evaluations and NExt-wave Healthcare Planning LIVE COVID FREE CMRS Flexible lung Coil Clinical MR Solutions LLC 2022-09-23 N/A
ITA #329712
Authorized under Clinical Trials Interim Order
Testing the validity and accuracy of a wireless connected vital sign monitoring bracelet in patients that have COVID-19, have recovered from COVID-19, and in non COVID-19 controls Zenzers 4Life iMD Research Inc. 2021-07-16 N/A
ITA #322514
Authorized under Clinical Trials Interim Order
REOM in COVID-19: Rapid expiratory occlusion monitor in SARS-CoV-2 Infection. Evaluation of a novel approach for self-administered home monitoring of respiratory function in COVID-19 patients. REO Monitor Thorasys Thoracic Medical Systems Inc. 2020-11-26 N/A
ITA #322374
Authorized under Clinical Trials Interim Order
Prevention of COVID-19 with Oral Vitamin D supplemental Therapy in Essential healthCare Teams (PROTECT trial) Nadal COVID-19 IgG/IgM Test Luminarie Canada Inc. 2020-11-14 NCT04483635
ITA #321106
Authorized under Clinical Trials Interim Order
Assess the performance of Spartan COVID-19 V2 System in a clinical setting in comparison to a laboratory (standard of care (SOC)) PCR Method (Canada Alternate)
Short title: Clinical Study Spartan COVID-19 V2 System (Canada Alternate)
The Spartan COVID-19 V2 System Spartan Bioscience Inc. 2020-10-29 NCT04575168
ITA #318909 Calibration of the Average Breathing Rate Measurement of the Cloud Dx Pulsewave Health Monitor (PAD-2A) Device (CCV-3) Pulsewave Health Monitor Cloud DX Inc. 2020-10-06 NCT04868630
ITA #315768 A Randomized Study Evaluating the Efficacy of the Vielight RX Plus in the Treatment of COVID-19 Respiratory Symptoms Vielight RX Plus Vielight Inc. 2020-09-02 NCT04418505
ITA #317236
Authorized under Clinical Trials Interim Order
COSMIC Bubble Helmet Non-Invasive Positive Pressure Ventilation in the Treatment of COVID-19 Patients - Feasibility Clinical Trial Cosmic Bubble Helmet Cosmic Technologies Inc. 2020-07-28 N/A
ITA #317693
Authorized under Clinical Trials Interim Order
A Multi Center, Point of Care, Near Patient Study to Evaluate the Usability of the Nadal COVID-19 IgG/IgM Test In the Intended Use Environment Nadal COVID-19 IgG/IgM Test Luminarie Canada Inc. 2020-07-24 N/A
ITA #317427
Authorized under Clinical Trials Interim Order
Can Remote Photoplethysmography Be Used for Contactless Vital Sign Acquisition in a Healthcare Setting? A Prospective Comparative Study smartphone rPPG Carebrook Technologies Inc. 2020-07-13 NCT04489407
ITA #316832
Authorized under Clinical Trials Interim Order
Use of High Dose Inhaled Nitric Oxide in Intubated Patients Admitted with COVID-19 Inhaled Nitric Oxide Delivery Device (INODD) 12th Man Technologies 2020-07-10 NCT04383002
ITA #315695 Evaluation of Clinical Sample Collection The Spartan COVID-19 System Spartan Bioscience Inc. 2020-06-23 NCT04473248
ITA #312830 Novel diagnostic and imaging strategies for early detection and surveillance of COVID-19 in the lung using artificial intelligence REVEAL 35C Flat Panel Detector KA Imaging Inc. 2020-06-12 N/A
ITA #313883 Inhaled NO for the Treatment of COVID-19 caused by SARS-CoV-2 LungFit Bro Beyond Air, Inc. 2020-05-22 NCT04456088
ITA #314979 Evaluating Auscul-X, a Touch Free Digital Stethoscope, for Physical Distancing to Protect Patients and Health Care Professionals from COVID-19 (The Auscul-X Study) Auscul-X Touchless Stethoscope System AusculSciences Canada Inc. 2020-05-19 NCT04570189
ITA #313362 An Open Label Safety Study of Inhaled Gaseous Nitric Oxide (gNO) for Adults & Adolescents with Non-Tuberculous Mycobacteria, Burkholderia spp, Aspergillus spp and Corona-like Viral (Sub-Study) Infections Inhaled Nitric Oxide Delivery Device (INODD) 12th Man Technologies 2020-04-07 N/A
ITA #287025 Continuous Negative Abdominal Pressure in Acute Respiratory Distress Syndrome (CNAP in ARDS) Continuous Negative Abdominal Pressure (CNAP) System The Hospital for Sick Children 2020-03-26 NCT03425318
ITA #322424
Authorized under Clinical Trials Interim Order
PRevention of COVID-19 with Oral Vitamin D supplemental Therapy in Essential healthCare Teams (PROTECT trial) TASSO-SST Tasso, Inc. 2020-12-02 NCT04483635
ITA #324553
Authorized under Clinical Trials Interim Order
Pilot Study to evaluate the Revoxa system in Hypoxic Patients Revoxa Oxygen Rebreather Ironstone Product Development Inc. 2020-12-07 NCT04699942
ITA #326341 Calibration of the Cloud Dx Pulsewave Health Monitor (PAD-2A) oscillometric wrist cuff home blood pressure monitor, according to the Association for the Advancement of Medical Instrumentation/ European Society of Hypertension / International Organization for Standardization Universal Standard (ISO 81060-2) (CCV-4) Pulsewave Health Monitor Cloud DX Inc. 2020-12-31 NCT048698262
ITA #329618
Authorized under Clinical Trials Interim Order
SpotLight-19 Research and Development (R&D) Study Project SpotLight-19 ISBRG Corporation 2021-04-09 NCT05198869
ITA #329248
Authorized under Clinical Trials Interim Order
Novel Salivary Rapid Testing of SARS-CoV-2 Sona Saliva C-19 Rapid Test Sona Nanotech Inc. 2021-04-12 NCT04877002
ITA #329256
Authorized under Clinical Trials Interim Order
A Single-Center, Point of Care, Comparative Study to Evaluate the Equivalence of the Test Results for Capillary Whole Blood, Venous Whole Blood and Serum or Plasma Samples When Tested With the Nadal COVID-19 IgG/IgM Test Nadal COVID-19 IgG/IgM Test Teracero Pharma Inc. 2021-04-13 N/A
ITA #329662
Authorized under Clinical Trials Interim Order
Multi center, randomized, double-blind, placebo-controlled trial evaluating the feasibility, acceptability, safety and potential effectiveness of adjunctive Photobiomodulation Therapy for COVID-19 pneumonia SunPowerLED Mini - Canopy Kerber Applied Research Inc. 2021-04-30 N/A
ITA #331297
Authorized under Clinical Trials Interim Order
UBC Rapid Testing for Self-Administration among an Asymptomatic Sample SARS-CoV-2 Antigen Self Test Nasal Roche Diagnostics 2021- 05-19 NCT04896710
ITA #330070 IRCM Post-COVID-19 (IPCO) Clinic: a multidisciplinary approach to evaluate short and long-term complications of COVID-19 Freestyle Libre Pro Flash Glucose Monitoring System Abbott Diabetes Care Ltd. 2021-05-21 NCT04736732
ITA #329614 Extubation Advisor: initial implementation and evaluation of a novel extubation clinical decision support tool

Extubation Advisor

OBS Medical Limited 2021-05-21 NCT04708509
ITA #328878 LIVE COVID FREE: Lung Structure-Function In SurVivors of Mild and SEvere COVID-19 Infection: 129Xe MRI and CT For Rapid Evaluations and NExt-wave Healthcare Planning 129 Xe Lung Coil RAPID Biomedical GmbH 2021-05-24 NCT04584671
ITA #330308 Lung Structure-Function In SurVivors of Mild and SEvere COVID19 Infection: 129Xe MRI and CT For Rapid Evaluations and NExt-wave Healthcare Planning (Short title: LIVE COVID FREE) Lung Coil for Hyperpolarized Gas RAPID Biomedical GmbH 2021-06-07 NCT05014516
ITA #330208 Lung Structure-Function In SurVivors of Mild and SEvere COVID19 Infection: 129Xe MRI and CT For Rapid Evaluations and NExt-wave Healthcare Planning (Short title: LIVE COVID FREE) CMRS Flexible Lung Coil Clinical MR Solutions LLC 2021-06-07 NCT05014516
ITA #330833
Authorized under Clinical Trials Interim Order
A Single-Center, Point of Care, Comparative Study to Evaluate the Equivalence of the Test Results for Capillary Whole Blood, Venous Whole Blood and EDTA Plasma Samples When Tested with the Lumivi Diagnostics™ SARS CoV-2 IgG Rapid Test Lumivi Diagnostics SARS CoV-2 IgG Rapid Test International Point of Care Inc. 2021-06-11 N/A
ITA #332004
Authorized under Clinical Trials Interim Order
A Multi Center, Point of Care Study to Evaluate the Usability of the Lumivi Diagnostic SARS CoV-2 IgG Rapid Test in the Intended Use Environment Lumivi Diagnostics SARS CoV-2 IgG Rapid Test International Point of Care Inc. 2021-07-13 N/A

ITA #334693
Authorized under Clinical Trials Interim Order

A Multi-Center Evaluation of Buccal Swabs with the Abbott ID NOW COVID-19 for Point-of-Care Detection SARS-CoV-2 in Pediatric Emergency Departments ID NOW COVID-19 The Governors of the University of Calgary 2021-09-03 NCT05040763

ITA #329700
Authorized under Clinical Trials Interim Order

POC Study to Evaluate the Performance of the Therma COVID-19 Rapid Antigen Test for Detection of SARS-CoV-2 Virus in Human Saliva COVID-19 Rapid Antigen Test Therma Bright Inc. 2021-09-16 NCT04878068
ITA #337438
Authorized under Clinical Trials Interim Order
Low-cost sensor system for COVID-19 patient monitoring: Validation of BRAEBON Vital Signs Monitor (VTS) BRAEBON Vital Signs Monitor BRAEBON Medical Corporation 2021-12-14 NCT05029011
ITA #336048 Impact of COVID-19 on cerebral health measured with quantitative MRI RA-MR System Thornhill Research Inc. 2021-12-22 N/A
ITA #338392
Authorized under Clinical Trials Interim Order
POC study to evaluate the performance of the RAMP COVID-19 Antigen Test for detection of SARS-CoV-2 Virus in symptomatic nasal swab specimens (POCCAT Study) RAMP COVID-19 ANTIGEN TEST RESPONSE BIOMEDICAL CORPORATION 2021-12-31 N/A

ITA #338359
Authorized under Clinical Trials Interim Order

A decentralized trial to determine the degree of concordance between COVISTIX™ results and an authorized RT-PCR test's results for in vitro qualitative detection of the SARS-CoV-2 Antigen for both Point of Care and Self-Testing (At Home Use) COVISTIX COVID-19 VIRUS Rapid Antigen Detection Test DICENTRA INCORPORATED 2022-01-25 N/A
ITA #343212
Authorized under the Clinical Trials COVID-19 Regulations
Clinical Performance Evaluation of COVID-19 Antigen Home Test COVID-19 Antigen Home Test DICENTRA INCORPORATED 2022-03-16 N/A

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