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

McGill University

Status and phase: Terminated; Phase 3

Conditions: Corona Virus Infection; SARS-CoV Infection; Coronavirus

Treatments: Drug: Hydroxychloroquine; Drug: Placebo oral tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT04421664

2020-6549

Details and patient eligibility

About

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.

Full 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.

Hydroxychloroquine may have antiviral effects against SARS-CoV2 which may decrease disease severity when given early. This trial will use a modification of standard malaria dosing of hydroxychloroquine to provide preemptive therapy for those with early symptoms.

This study is a continuation of NCT04308668 which looked at post-exposure prophylaxis (now closed) and early treatment in the USA (now closed, data to be pooled) and Canada (which continues in this study). On April 28, 2020 NCT04308668 changed its primary outcome to symptomatic improvement in the preemptive therapy arm. This study continues enrollment for the primary ordinal outcome of hospitalization; hospitalization with intensive care stay; or death.

People in the participating Canadian provinces can help answer this critically important question. No in-person visits are needed.

The doses of hydroxychloroquine being used have been approved by Health Canada.

This trial is targeting the following groups of people:

If you are symptomatic with a positive COVID-19 test within the first 4 days of symptoms and are not hospitalized; OR If you have had occupational exposure with known exposure to someone with lab-confirmed COVID-19 within the last 14 days AND have compatible symptoms starting within the last 4 days;

You may participate if you live anywhere in the Canadian Provinces of Quebec, Manitoba, Alberta, British Columbia, Newfoundland or Ontario.

For information on how to participate in the research trial, go to:

www.covid-19research.ca

Enrollment: 70 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

70 participants in 2 patient groups, including a placebo group

Treatment

Experimental group

Description:

Participants in this arm will receive the study drug, hydroxychloroquine.

Treatment:

Drug: Hydroxychloroquine

Placebo

Placebo Comparator group

Description:

Participants in this arm will receive a placebo treatment.

Treatment:

Drug: Placebo oral tablet