Preemptive Therapy for SARS-Coronavirus-2 (COVID-19 PEP Canada)

• Status: Terminated
• Trial end date: 2020-08-17
• Target enrollment: 0
• Participant gender: All

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 severity.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
• Collaborators: Eastern Health; Lawson Health Research Institute; McMaster University; University of Alberta; University of British Columbia; University of Manitoba; University of Minnesota
• Treatments: Hydroxychloroquine

Criteria

Inclusion Criteria:

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 Criteria:

• 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