Post-exposure Prophylaxis / Preemptive Therapy for SARS-Coronavirus-2
Completed · Phase 3 · Has a placebo group
Conditions studied: Corona Virus Infection, Acute Respiratory Distress Syndrome, SARS-CoV Infection, Coronavirus, Coronavirus Infections
In brief
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.
Key facts
- Study ID
- NCT04308668
- Run by
- University of Minnesota
- People needed
- 1312
- Starts
- 2020-03-17
- Expected to finish
- 2020-05-20
- Last updated by the study team
- 2021-05-13
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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;
You may not qualify if…
- 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
Where it is running
- 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 — Montreal, Quebec, Canada
Full record on ClinicalTrials.gov
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