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
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
Other Name: Plaquenil
Other: Placebo
4 placebo tablets once, followed in 6 to 8 hours by 3 tablets, then 3 tablets once-a-day for 4 consecutive days
Inclusion Criteria:
- Provision of informed consent
- Exposure to a COVID19 case within 4 days as either a household contact or occupational
exposure, OR
- Symptomatic COVID19 case with confirmed diagnosis within 4 days of symptom onset OR
symptomatic high risk exposure with known COVID19 contact and within 4 days of symptom
onset;
Exclusion Criteria:
- Current hospitalization
- Allergy to hydroxychloroquine
- Retinal eye disease
- Known glucose-6 phosphate dehydrogenase (G-6-PD) deficiency
- Known chronic kidney disease, stage 4 or 5 or receiving dialysis
- Structural or ischemic heart disease
- Personal or Family History of Prolonged QT syndrome
- Weight < 50 kg
- Known Porphyria
- Current use of: hydroxychloroquine or cardiac medicines of: flecainide, Tambocor;
amiodarone, Cordarone, Pacerone; digoxin or Digox, Digitek, Lanoxin; procainamide or
Procan, Procanbid, propafenone, Rythmal, sotalol;
- Current use of medicines which prolong the QT interval including:
- Antimicrobials: levofloxacin, ciprofloxacin, moxifloxacin, azithromycin,
clarithromycin, erythromycin, ketoconazole, itraconazole, or mefloquine
- Antidepressants: amitriptyline, citalopram, desipramine, escitalopram,
imipramine, doxepin, fluoxetine, wellbutrin, or venlafaxine
- Antipsychotic or mood stabilizers: haloperidol, droperidol, lithium, quetiapine,
thioridazine, ziprasidone
- Methadone
- Sumatriptan, zolmitriptan
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
Research Institute of the McGill University Heath Centre
Montréal, Quebec, Canada
David Boulware, MD, MPH, Principal Investigator
University of Minnesota