Status:
COMPLETED
Post-exposure Prophylaxis / Preemptive Therapy for SARS-Coronavirus-2
Lead Sponsor:
University of Minnesota
Collaborating Sponsors:
McGill University Health Centre/Research Institute of the McGill University Health Centre
University of Manitoba
Conditions:
Corona Virus Infection
Acute Respiratory Distress Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 preem...
Detailed Description
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, isola...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 17 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 20 2020
Estimated Enrollment :
1312 Patients enrolled
Trial Details
Trial ID
NCT04308668
Start Date
March 17 2020
End Date
May 20 2020
Last Update
May 13 2021
Active Locations (5)
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1
Nationwide Enrollment via Internet, please email: covid19@umn.edu
Minneapolis, Minnesota, United States, 55455
2
University of Minnesota
Minneapolis, Minnesota, United States, 55455
3
University of Alberta
Edmonton, Alberta, Canada
4
University of Manitoba
Winnipeg, Manitoba, Canada