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Preemptive Therapy for SARS-Coronavirus-2 (COVID-19 PEP Canada)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04421664
Recruitment Status : Recruiting
First Posted : June 9, 2020
Last Update Posted : June 9, 2020
Sponsor:
Collaborators:
University of Manitoba
University of Alberta
University of British Columbia
McMaster University
Lawson Health Research Institute
Eastern Health
University of Minnesota
Information provided by (Responsible Party):
Todd Lee, McGill University Health Centre/Research Institute of the McGill University Health Centre

Brief Summary:

Study Objective:

To test if early preemptive hydroxychloroquine therapy can prevent disease progression in persons with known symptomatic COVID-19 disease, decreasing hospitalizations and symptom severity.


Condition or disease Intervention/treatment Phase
Corona Virus Infection SARS-CoV Infection Coronavirus Drug: Hydroxychloroquine Drug: Placebo oral tablet Phase 3

Detailed Description:

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a rapidly emerging viral infection causing COVID19. Therapy is generally not given to persons who are not hospitalized.

Hydroxychloroquine may have antiviral effects against SARS-CoV2 which may decrease disease severity when given early. This trial will use a modification of standard malaria dosing of hydroxychloroquine to provide preemptive therapy for those with early symptoms.

This study is a continuation of NCT04308668 which looked at post-exposure prophylaxis (now closed) and early treatment in the USA (now closed, data to be pooled) and Canada (which continues in this study). On April 28, 2020 NCT04308668 changed its primary outcome to symptomatic improvement in the preemptive therapy arm. This study continues enrollment for the primary ordinal outcome of hospitalization; hospitalization with intensive care stay; or death.

People in the participating Canadian provinces can help answer this critically important question. No in-person visits are needed.

The doses of hydroxychloroquine being used have been approved by Health Canada.

This trial is targeting the following groups of people:

If you are symptomatic with a positive COVID-19 test within the first 4 days of symptoms and are not hospitalized; OR If you have had occupational exposure with known exposure to someone with lab-confirmed COVID-19 within the last 14 days AND have compatible symptoms starting within the last 4 days;

You may participate if you live anywhere in the Canadian Provinces of Quebec, Manitoba, Alberta, British Columbia, Newfoundland or Ontario.

For information on how to participate in the research trial, go to:

www.covid-19research.ca

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Preemptive Therapy for SARS-Coronavirus-2 (COVID-19 PEP Canada)
Actual Study Start Date : March 25, 2020
Estimated Primary Completion Date : July 1, 2020
Estimated Study Completion Date : August 26, 2020


Arm Intervention/treatment
Experimental: Treatment
Participants in this arm will receive the study drug, hydroxychloroquine.
Drug: Hydroxychloroquine
200mg tablet; 800 mg orally once, followed in 6 to 8 hours by 600 mg, then 600mg once a day for 4 consecutive days

Placebo Comparator: Placebo
Participants in this arm will receive a placebo treatment.
Drug: Placebo oral tablet
4 placebo tablets once, followed in 6 to 8 hours by 3 tablets, then 3 tablets once-a-day for 4 consecutive days




Primary Outcome Measures :
  1. Ordinal Scale of COVID19 Disease Severity at 14 days [ Time Frame: 14 days ]
    Participants will self-report disease severity status as one of the following 3 options; no COVID19 illness (score of 1), COVID19 illness with no hospitalization (score of 2), or COVID19 illness with hospitalization or death (score of 3). Increased scale score indicates greater disease severity. Outcome is reported as the percent of participants who fall into each category per arm.


Secondary Outcome Measures :
  1. Incidence of Hospitalization [ Time Frame: 14 days ]
    Outcome reported as the number of participants in each arm who require hospitalization for COVID19-related disease.

  2. Incidence of COVID-19 related Death [ Time Frame: 90 days ]
    Outcome reported as the number of participants in each arm who expire due to COVID-19-related disease.

  3. Incidence of all-cause Death [ Time Frame: 90 days ]
    Outcome reported as the number of participants in each arm who expire due to all causes.

  4. Incidence of All-Cause Study Medicine Discontinuation or Withdrawal [ Time Frame: 14 days ]
    Outcome reported as the number of participants in each arm who discontinue or withdraw medication use for any reason.

  5. Overall symptom severity at 5 and 14 days [ Time Frame: 5 and 14 days ]
    Visual Analog Scale 0-10 score of rating overall symptom severity (0 = no symptoms; 10 = most severe)

  6. Overall change in disease severity over 14 days among those who are symptomatic at baseline [ Time Frame: 14 days ]
    Repeated Measure mixed regression model of change in: Visual Analog Scale 0-10 score of rating overall symptom severity (0 = no symptoms; 10 = most severe)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Age 18 years of age or older AND provision of informed consent

WITH

Symptomatic COVID-19 disease with confirmed diagnosis with PCR+ SARS-CoV-2 within <= 4 days of symptoms

OR

Healthcare worker with compatible symptoms with exposure to known PCR+ case <= 14 days (and no available/pending testing for the individual).

Exclusion Criteria:

  • Current hospitalization
  • Allergy to chloroquine or hydroxychloroquine
  • Severe diarrhea and/or vomiting
  • Significant hepatic impairment defined as known cirrhosis with history of hepatic encephalopathy or ascites.
  • Prior retinal eye disease
  • Concurrent malignancy requiring chemotherapy
  • Known Chronic Kidney disease, Stage 4 or 5 or dialysis.
  • Known glucose-6 phosphate dehydrogenase (G6PD) deficiency.
  • Known ventricular arrythmia, known prolonged QTc interval, or any known episode of sudden cardiac death
  • Known Porphyria
  • Weight <40 kg
  • Known Pregnancy of Breastfeeding
  • Current use of chloroquine or hydroxychloroquine
  • Current use of Artemether, Dapsone, Lumefantrine or Mefloquine
  • Current use of Cardiac medicines: amiodarone, digoxin, dofetilide, flecainide, procainamide, sotalol, or propafenone
  • Current use of the following antimicrobials: levofloxacin, ciprofloxacin, moxifloxacin, azithromycin, clarithromycin, erythromycin, ketoconazole, or itraconazole
  • Current use of the following antidepressants: amitriptyline, citalopram, desipramine, escitalopram, imipramine, doxepin, fluoxetine, sertraline, bupropion (Wellbutrin), or venlafaxine
  • Current use of the following antipsychotic or mood stabilizers: haloperidol, droperidol, lithium, quetiapine, thioridazine, ziprasidone
  • Current use of methadone
  • Current use of Sumatriptan, Zolmitriptan other than "as needed"
  • Current use of systemic chemotherapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04421664


Contacts
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Contact: Todd C Lee, MD MPH FIDSA 5149341934 ext 23730 quebec@idtrials.com

Locations
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United States, Minnesota
University of Minnesota Completed
Minneapolis, Minnesota, United States, 55455
Canada, Alberta
University of Alberta Recruiting
Edmonton, Alberta, Canada
Contact: Ilan Schwartz, MD       alberta@idtrials.com   
Canada, British Columbia
University of British Columbia Recruiting
Vancouver, British Columbia, Canada
Contact: Sara Belga, MD       bc@idtrials.com   
Canada, Manitoba
University of Manitoba Recruiting
Winnipeg, Manitoba, Canada
Contact: Ryan Zarychanski, MD       manitoba@idtrials.com   
Contact: Lauren E Kelly, PhD         
Sub-Investigator: Glen Drobot, MD         
Sub-Investigator: Lauren MacKenzie, MD         
Sub-Investigator: Sylvain Lother, MD         
Canada, Newfoundland and Labrador
Eastern Health Recruiting
Saint John's, Newfoundland and Labrador, Canada
Contact: Peter Daley, MD MSc       nfld@idtrials.com   
Canada, Ontario
McMaster University Recruiting
Hamilton, Ontario, Canada
Contact: Zain Chagla, MD       ontario@idtrials.com   
Lawson Health Research Institute Recruiting
London, Ontario, Canada
Contact: Michael Silverman, MD       ontario@idtrials.com   
Canada, Quebec
Research Institute of the McGill University Health Centre Recruiting
Montréal, Quebec, Canada, H4A3J1
Contact: Todd C Lee, MD MPH FIDSA    514-934-1934 ext 23730    quebec@idtrials.com   
Sub-Investigator: Emily G McDonald, MD MSc         
Sub-Investigator: Matthew P Cheng, MD         
Sponsors and Collaborators
McGill University Health Centre/Research Institute of the McGill University Health Centre
University of Manitoba
University of Alberta
University of British Columbia
McMaster University
Lawson Health Research Institute
Eastern Health
University of Minnesota
Investigators
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Principal Investigator: Todd C Lee, MD MPH FIDSA Research Institute of the McGill University Health Centre
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Responsible Party: Todd Lee, Associate Professor of Medicine, McGill University Health Centre/Research Institute of the McGill University Health Centre
ClinicalTrials.gov Identifier: NCT04421664    
Other Study ID Numbers: 2020-6549
First Posted: June 9, 2020    Key Record Dates
Last Update Posted: June 9, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified dataset will be included with publication.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: At time of publication
Access Criteria: To be publicly provided
URL: http://www.covid-19research.ca

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Todd Lee, McGill University Health Centre/Research Institute of the McGill University Health Centre:
COVID-19
SARS-COV-2
Coronavirus
Corona virus
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Coronavirus Infections
Severe Acute Respiratory Syndrome
Virus Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Respiratory Tract Infections
Respiratory Tract Diseases
Hydroxychloroquine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents