Preemptive Therapy for SARS-Coronavirus-2 (COVID-19 PEP Canada)
Stopped early · Phase 3 · Has a placebo group
Conditions studied: Corona Virus Infection, SARS-CoV Infection, Coronavirus
In brief
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.
Key facts
- Study ID
- NCT04421664
- Run by
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- People needed
- 70
- Starts
- 2020-03-25
- Expected to finish
- 2020-08-17
- Last updated by the study team
- 2024-10-15
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age 18 years of age or older AND provision of informed consent
- WITH
- Symptomatic COVID-19 disease with confirmed diagnosis with PCR+ SARS-CoV-2 within <= 4 days of symptoms
- OR
- Healthcare worker with compatible symptoms with exposure to known PCR+ case <= 14 days (and no available/pending testing for the individual).
You may not qualify if…
- Current hospitalization
- Allergy to chloroquine or hydroxychloroquine
- Severe diarrhea and/or vomiting
- Significant hepatic impairment defined as known cirrhosis with history of hepatic encephalopathy or ascites.
- Prior retinal eye disease
- Concurrent malignancy requiring chemotherapy
- Known Chronic Kidney disease, Stage 4 or 5 or dialysis.
- Known glucose-6 phosphate dehydrogenase (G6PD) deficiency.
- Known ventricular arrythmia, known prolonged QTc interval, or any known episode of sudden cardiac death
- Known Porphyria
- Weight <40 kg
- Known Pregnancy of Breastfeeding
- Current use of chloroquine or hydroxychloroquine
- Current use of Artemether, Dapsone, Lumefantrine or Mefloquine
- Current use of Cardiac medicines: amiodarone, digoxin, dofetilide, flecainide, procainamide, sotalol, or propafenone
- Current use of the following antimicrobials: levofloxacin, ciprofloxacin, moxifloxacin, azithromycin, clarithromycin, erythromycin, ketoconazole, or itraconazole
- Current use of the following antidepressants: amitriptyline, citalopram, desipramine, escitalopram, imipramine, doxepin, fluoxetine, sertraline, bupropion (Wellbutrin), or venlafaxine
- Current use of the following antipsychotic or mood stabilizers: haloperidol, droperidol, lithium, quetiapine, thioridazine, ziprasidone
- Current use of methadone
- Current use of Sumatriptan, Zolmitriptan other than "as needed"
- Current use of systemic chemotherapy
Where it is running
- 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
- 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
Full record on ClinicalTrials.gov
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