Study Objective: 1. To test if post-exposure prophylaxis with hydroxychloroquine can prevent symptomatic COVID-19 disease after known exposure to the SARS-CoV-2 coronavirus. 2. 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. The current strategy uses a public health model of identifying infected cases, isolation, and quarantine to stop transmission. Once exposed, observation is standard-of-care. Therapy is generally not given to persons who are not hospitalized. The doses of hydroxychloroquine being used are within the normal standard FDA-approved doses. Hydroxychloroquine may have antiviral effects against SARS-COV2 which may prevent COVID-19 disease or early preemptive therapy may decrease disease severity. This trial will use a modification of standard malaria dosing of hydroxychloroquine to provide post-exposure prophylaxis to prevent disease or preemptive therapy for those with early symptoms. People around the the United States and Canada can participate to help answer this critically important question. No in-person visits are needed. This trial is targeting 5 groups of people NATIONWIDE to participate: 1. If you are symptomatic with a positive COVID-19 test within the first 4 days of symptoms and are not hospitalized; OR 2. If you live with someone who has been diagnosed with COVID-19, with your last exposure within the last 4 days, and do not have any symptoms; OR 3. If you live with someone who has been diagnosed with COVID-19, and your symptoms started within the last 4 days; OR 4. If you have had occupational exposure with known exposure to someone with lab-confirmed COVID-19 within the last 4 days and do not have symptoms; OR 5. If you have had occupational exposure with known exposure to someone with lab-confirmed COVID-19 within the last 4 days AND have compatible symptoms starting within the last 4 days; You may participate if you live anywhere in the United States (including territories) or in the Canadian Provinces of Quebec, Manitoba, Alberta, or Ontario. For information on how to participate in the research trial, go to covidpep.umn.edu or email covid19@umn.edu for instructions. Please check your spam folder if you email. In Canada, for trial information, please go to: www.covid-19research.ca
Study Type
INTERVENTIONAL
Allocation
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
Nationwide Enrollment via Internet, please email: covid19@umn.edu
Minneapolis, Minnesota, United States
University of Minnesota
Minneapolis, Minnesota, United States
University of Alberta
Edmonton, Alberta, Canada
University of Manitoba
Winnipeg, Manitoba, Canada
Number of Participants With Active COVID-19 Disease at Day 14 Among Those Who Were Asymptomatic at Baseline
Number of participants at 14 days post enrollment with active COVID19 disease among those who were asymptomatic at baseline.
Time frame: 14 days
Change in Disease Severity Over 14 Days Among Those Who Are Symptomatic at Baseline
Visual Analog Scale 0-10 score of rating overall symptom severity (0 = no symptoms; 10 = most severe)
Time frame: baseline and 14 days
Rate of Hospitalization
Outcome reported as the number of participants in each arm who require hospitalization for COVID19-related disease.
Time frame: 14 days
Rate of Death
Outcome reported as the number of participants in each arm who expire due to COVID-19-related disease through study completion of 14 days. For those hospitalized within the 14-day study period, the protocol specified follow up would occur for up to 90 days to capture the final outcome of participants' hospitalization. Approximately 30-days was the maximal follow up for hospitalization outcome needed in the trial.
Time frame: Approximately 30 days
Rate of Confirmed SARS-CoV-2 Detection
Outcome reported as the number of participants in each arm who have confirmed SARS-CoV-2 infection.
Time frame: 14 days
Occurrence of Symptoms Compatible With COVID-19 (Possible Disease)
Outcome reported as the number of participants in each arm who self-report symptoms compatible with COVID-19 infection.
Time frame: 14 days
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RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
1,312
Research Institute of the McGill University Heath Centre
Montreal, Quebec, Canada
Rate 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
Number of Participants With Severe COVID-19 Disease at 14 Days Among Those Who Are Symptomatic at Trial Entry
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 number of participants who report a score of 3.
Time frame: 14 days