Status:
TERMINATED
Preemptive Therapy for SARS-Coronavirus-2 (COVID-19 PEP Canada)
Lead Sponsor:
McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborating Sponsors:
University of Manitoba
University of Alberta
Conditions:
Corona Virus Infection
SARS-CoV Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 sev...
Detailed Description
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a rapidly emerging viral infection causing COVID19. Therapy is generally not given to persons who are not hospitalized. Hydroxychloroqu...
Eligibility Criteria
Inclusion
- 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).
Exclusion
- 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
Key Trial Info
Start Date :
March 25 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 17 2020
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT04421664
Start Date
March 25 2020
End Date
August 17 2020
Last Update
October 15 2024
Active Locations (8)
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1
University of Minnesota
Minneapolis, Minnesota, United States, 55455
2
University of Alberta
Edmonton, Alberta, Canada
3
University of British Columbia
Vancouver, British Columbia, Canada
4
University of Manitoba
Winnipeg, Manitoba, Canada