NCT04421664

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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

Conditions

• Corona Virus Infection
• SARS-CoV Infection
• Coronavirus

Interventions

Type	Name	Description
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
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

Timeline

• Start date: 2020-03-25
• Primary completion: 2020-08-17
• Completion: 2020-08-17
• First posted: 2020-06-09
• Last updated: 2024-10-15

Locations

8 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study