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

April 5, 2022 updated by: Todd C. Lee MD MPH FIDSA, McGill University Health Centre/Research Institute of the McGill University Health Centre

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada
        • University of Alberta
    • British Columbia
      • Vancouver, British Columbia, Canada
        • University of British Columbia
    • Manitoba
      • Winnipeg, Manitoba, Canada
        • University of Manitoba
    • Newfoundland and Labrador
      • Saint John's, Newfoundland and Labrador, Canada
        • Eastern Health
    • Ontario
      • Hamilton, Ontario, Canada
        • McMaster University
      • London, Ontario, Canada
        • Lawson Health Research Institute
    • Quebec
      • Montréal, Quebec, Canada, H4A3J1
        • Research Institute of the McGill University Health Centre
  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Hospitalization
Time Frame: 14 days
Outcome reported as the number of participants in each arm who require hospitalization for COVID19-related disease.
14 days
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.
90 days
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.
90 days
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.
14 days
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)
5 and 14 days
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)
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Collaborators

University of Manitoba
University of British Columbia
University of Alberta
McMaster University
University of Minnesota
Lawson Health Research Institute
Eastern Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 25, 2020

Primary Completion (ACTUAL)

August 17, 2020

Study Completion (ACTUAL)

August 17, 2020

Study Registration Dates

First Submitted

June 5, 2020

First Submitted That Met QC Criteria

June 5, 2020

First Posted (ACTUAL)

June 9, 2020

Study Record Updates

Last Update Posted (ACTUAL)

April 13, 2022

Last Update Submitted That Met QC Criteria

April 5, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-6549

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified dataset will be included with publication.

IPD Sharing Time Frame

At time of publication

IPD Sharing Access Criteria

To be publicly provided

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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