Post-exposure Prophylaxis / Preemptive Therapy for SARS-Coronavirus-2

• Status: Completed
• Trial end date: 2020-05-20
• Target enrollment: 0
• Participant gender: All

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 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: University of Minnesota
• Collaborators: McGill University Health Centre/Research Institute of the McGill University Health Centre; University of Alberta; University of Manitoba
• Treatments: Hydroxychloroquine

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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