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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
70
200mg tablet; 800 mg orally once, followed in 6 to 8 hours by 600 mg, then 600mg once a day for 4 consecutive days
4 placebo tablets once, followed in 6 to 8 hours by 3 tablets, then 3 tablets once-a-day for 4 consecutive days
University of Minnesota
Minneapolis, Minnesota, United States
University of Alberta
Edmonton, Alberta, Canada
University of British Columbia
Vancouver, British Columbia, Canada
University of Manitoba
Winnipeg, Manitoba, Canada
Ordinal Scale of COVID19 Disease Severity at 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.
Time frame: 14 days
Incidence of Hospitalization
Outcome reported as the number of participants in each arm who require hospitalization for COVID19-related disease.
Time frame: 14 days
Incidence of COVID-19 related Death
Outcome reported as the number of participants in each arm who expire due to COVID-19-related disease.
Time frame: 90 days
Incidence of all-cause Death
Outcome reported as the number of participants in each arm who expire due to all causes.
Time frame: 90 days
Incidence of All-Cause Study Medicine Discontinuation or Withdrawal
Outcome reported as the number of participants in each arm who discontinue or withdraw medication use for any reason.
Time frame: 14 days
Overall symptom severity at 5 and 14 days
Visual Analog Scale 0-10 score of rating overall symptom severity (0 = no symptoms; 10 = most severe)
Time frame: 5 and 14 days
Overall change in disease severity over 14 days among those who are symptomatic at baseline
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Eastern Health
St. John's, Newfoundland and Labrador, Canada
McMaster University
Hamilton, Ontario, Canada
Lawson Health Research Institute
London, Ontario, Canada
Research Institute of the McGill University Health Centre
Montreal, Quebec, Canada
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)
Time frame: 14 days