Preemptive Therapy for SARS-Coronavirus-2 (COVID-19 PEP Canada)
NCT ID: NCT04421664
Last Updated: 2024-10-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
70 participants
INTERVENTIONAL
2020-03-25
2020-08-17
Brief Summary
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To test if early preemptive hydroxychloroquine therapy can prevent disease progression in persons with known symptomatic COVID-19 disease, decreasing hospitalizations and symptom severity.
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Treatment
Participants in this arm will receive the study drug, hydroxychloroquine.
Hydroxychloroquine
200mg tablet; 800 mg orally once, followed in 6 to 8 hours by 600 mg, then 600mg once a day for 4 consecutive days
Placebo
Participants in this arm will receive a placebo treatment.
Placebo oral tablet
4 placebo tablets once, followed in 6 to 8 hours by 3 tablets, then 3 tablets once-a-day for 4 consecutive days
Interventions
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Hydroxychloroquine
200mg tablet; 800 mg orally once, followed in 6 to 8 hours by 600 mg, then 600mg once a day for 4 consecutive days
Placebo oral tablet
4 placebo tablets once, followed in 6 to 8 hours by 3 tablets, then 3 tablets once-a-day for 4 consecutive days
Eligibility Criteria
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Inclusion Criteria
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
* 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
18 Years
ALL
No
Sponsors
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University of Manitoba
OTHER
University of Alberta
OTHER
University of British Columbia
OTHER
McMaster University
OTHER
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
OTHER
Eastern Health
OTHER
University of Minnesota
OTHER
McGill University Health Centre/Research Institute of the McGill University Health Centre
OTHER
Responsible Party
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Todd C. Lee MD MPH FIDSA
Associate Professor of Medicine
Principal Investigators
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Todd C Lee, MD MPH FIDSA
Role: PRINCIPAL_INVESTIGATOR
Research Institute of the McGill University Health Centre
Locations
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University of Minnesota
Minneapolis, Minnesota, United States
University of Alberta
Edmonton, Alberta, Canada
University of British Columbia
Vancouver, British Columbia, Canada
University of Manitoba
Winnipeg, Manitoba, Canada
Eastern Health
St. John's, Newfoundland and Labrador, Canada
McMaster University
Hamilton, Ontario, Canada
Lawson Health Research Institute
London, Ontario, Canada
Research Institute of the McGill University Health Centre
Montreal, Quebec, Canada
Countries
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References
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Skipper CP, Pastick KA, Engen NW, Bangdiwala AS, Abassi M, Lofgren SM, Williams DA, Okafor EC, Pullen MF, Nicol MR, Nascene AA, Hullsiek KH, Cheng MP, Luke D, Lother SA, MacKenzie LJ, Drobot G, Kelly LE, Schwartz IS, Zarychanski R, McDonald EG, Lee TC, Rajasingham R, Boulware DR. Hydroxychloroquine in Nonhospitalized Adults With Early COVID-19 : A Randomized Trial. Ann Intern Med. 2020 Oct 20;173(8):623-631. doi: 10.7326/M20-4207. Epub 2020 Jul 16.
Boulware DR, Pullen MF, Bangdiwala AS, Pastick KA, Lofgren SM, Okafor EC, Skipper CP, Nascene AA, Nicol MR, Abassi M, Engen NW, Cheng MP, LaBar D, Lother SA, MacKenzie LJ, Drobot G, Marten N, Zarychanski R, Kelly LE, Schwartz IS, McDonald EG, Rajasingham R, Lee TC, Hullsiek KH. A Randomized Trial of Hydroxychloroquine as Postexposure Prophylaxis for Covid-19. N Engl J Med. 2020 Aug 6;383(6):517-525. doi: 10.1056/NEJMoa2016638. Epub 2020 Jun 3.
Lother SA, Abassi M, Agostinis A, Bangdiwala AS, Cheng MP, Drobot G, Engen N, Hullsiek KH, Kelly LE, Lee TC, Lofgren SM, MacKenzie LJ, Marten N, McDonald EG, Okafor EC, Pastick KA, Pullen MF, Rajasingham R, Schwartz I, Skipper CP, Turgeon AF, Zarychanski R, Boulware DR. Post-exposure prophylaxis or pre-emptive therapy for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2): study protocol for a pragmatic randomized-controlled trial. Can J Anaesth. 2020 Sep;67(9):1201-1211. doi: 10.1007/s12630-020-01684-7. Epub 2020 May 7.
Other Identifiers
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2020-6549
Identifier Type: -
Identifier Source: org_study_id
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