Preemptive Therapy for SARS-Coronavirus-2 (COVID-19 PEP Canada)
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|ClinicalTrials.gov Identifier: NCT04421664|
Recruitment Status : Terminated (Request of Health Canada after publication of https://doi.org/10.7326/M20-4207)
First Posted : June 9, 2020
Last Update Posted : September 22, 2020
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|
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:
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Preemptive Therapy for SARS-Coronavirus-2 (COVID-19 PEP Canada)|
|Actual Study Start Date :||March 25, 2020|
|Actual Primary Completion Date :||August 17, 2020|
|Actual Study Completion Date :||August 17, 2020|
Participants in this arm will receive the study 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
- 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.
- Incidence of Hospitalization [ Time Frame: 14 days ]Outcome reported as the number of participants in each arm who require hospitalization for COVID19-related disease.
- 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.
- 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.
- 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.
- 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)
- 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)
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
|United States, Minnesota|
|University of Minnesota|
|Minneapolis, Minnesota, United States, 55455|
|University of Alberta|
|Edmonton, Alberta, Canada|
|Canada, British Columbia|
|University of British Columbia|
|Vancouver, British Columbia, Canada|
|University of Manitoba|
|Winnipeg, Manitoba, Canada|
|Canada, Newfoundland and Labrador|
|Saint John's, Newfoundland and Labrador, Canada|
|Hamilton, Ontario, Canada|
|Lawson Health Research Institute|
|London, Ontario, Canada|
|Research Institute of the McGill University Health Centre|
|Montréal, Quebec, Canada, H4A3J1|
|Principal Investigator:||Todd C Lee, MD MPH FIDSA||Research Institute of the McGill University Health Centre|