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Post-exposure Prophylaxis / Preemptive Therapy for SARS-Coronavirus-2 (COVID-19 PEP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04308668
Recruitment Status : Completed
First Posted : March 16, 2020
Last Update Posted : July 17, 2020
Sponsor:
Collaborators:
McGill University Health Centre/Research Institute of the McGill University Health Centre
University of Manitoba
University of Alberta
Information provided by (Responsible Party):
University of Minnesota

Tracking Information
First Submitted Date  ICMJE March 11, 2020
First Posted Date  ICMJE March 16, 2020
Last Update Posted Date July 17, 2020
Actual Study Start Date  ICMJE March 17, 2020
Actual Primary Completion Date May 20, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 28, 2020)
  • Incidence of COVID19 Disease among those who are asymptomatic at baseline [ Time Frame: 14 days ]
    Number of participants at 14 days post enrollment with active COVID19 disease.
  • Overall change in disease severity over 14 days among those who are symptomatic at baseline [ Time Frame: 14 days ]
    Repeated Measure mixed regression model of change in: Visual Analog Scale 0-10 score of rating overall symptom severity (0 = no symptoms; 10 = most severe)
Original Primary Outcome Measures  ICMJE
 (submitted: March 11, 2020)
  • Incidence of COVID19 Disease [ Time Frame: 14 days ]
    Number of participants at 14 days post enrollment with active COVID19 disease.
  • Ordinal Scale of COVID19 Disease Severity [ Time Frame: 14 days ]
    Participants will self-report disease severity status as one of the following 3 options; no COVID19 illness (score of 1), COVID19 illness with no hospitalization (score of 2), or COVID19 illness with hospitalization or death (score of 3). Increased scale score indicates greater disease severity. Outcome is reported as the percent of participants who fall into each category per arm.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 28, 2020)
  • Incidence of Hospitalization [ Time Frame: 14 days ]
    Outcome reported as the number of participants in each arm who require hospitalization for COVID19-related disease.
  • Incidence of Death [ Time Frame: 90 days ]
    Outcome reported as the number of participants in each arm who expire due to COVID-19-related disease.
  • Incidence of Confirmed SARS-CoV-2 Detection [ Time Frame: 14 days ]
    Outcome reported as the number of participants in each arm who have confirmed SARS-CoV-2 infection.
  • Incidence of Symptoms Compatible with COVID19 (possible disease) [ Time Frame: 90 days ]
    Outcome reported as the number of participants in each arm who self-report symptoms compatible with COVID19 infection.
  • Incidence of All-Cause Study Medicine Discontinuation or Withdrawal [ Time Frame: 14 days ]
    Outcome reported as the number of participants in each arm who discontinue or withdraw medication use for any reason.
  • Overall symptom severity at 5 and 14 days [ Time Frame: 5 and 14 days ]
    Visual Analog Scale 0-10 score of rating overall symptom severity (0 = no symptoms; 10 = most severe)
  • Ordinal Scale of COVID19 Disease Severity at 14 days among those who are symptomatic at trial entry [ Time Frame: 14 days ]
    Participants will self-report disease severity status as one of the following 3 options; no COVID19 illness (score of 1), COVID19 illness with no hospitalization (score of 2), or COVID19 illness with hospitalization or death (score of 3). Increased scale score indicates greater disease severity. Outcome is reported as the percent of participants who fall into each category per arm.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 11, 2020)
  • Incidence of Hospitalization [ Time Frame: 14 days ]
    Outcome reported as the number of participants in each arm who require hospitalization for COVID19-related disease.
  • Incidence of Death [ Time Frame: 90 days ]
    Outcome reported as the number of participants in each arm who expire due to COVID-19-related disease.
  • Incidence of Confirmed SARS-CoV-2 Detection [ Time Frame: 14 days ]
    Outcome reported as the number of participants in each arm who have confirmed SARS-CoV-2 infection.
  • Incidence of Symptoms Compatible with COVID19 (possible disease) [ Time Frame: 90 days ]
    Outcome reported as the number of participants in each arm who self-report symptoms compatible with COVID19 infection.
  • Incidence of All-Cause Study Medicine Discontinuation or Withdrawal [ Time Frame: 14 days ]
    Outcome reported as the number of participants in each arm who discontinue or withdraw medication use for any reason.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Post-exposure Prophylaxis / Preemptive Therapy for SARS-Coronavirus-2
Official Title  ICMJE Post-exposure Prophylaxis or Preemptive Therapy for SARS-Coronavirus-2: A Pragmatic Randomized Clinical Trial
Brief 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.
Detailed Description

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a rapidly emerging viral infection causing COVID19. The current strategy uses a public health model of identifying infected cases, isolation, and quarantine to stop transmission. Once exposed, observation is standard-of-care. Therapy is generally not given to persons who are not hospitalized. The doses of hydroxychloroquine being used are within the normal standard FDA-approved doses.

Hydroxychloroquine may have antiviral effects against SARS-COV2 which may prevent COVID-19 disease or early preemptive therapy may decrease disease severity. This trial will use a modification of standard malaria dosing of hydroxychloroquine to provide post-exposure prophylaxis to prevent disease or preemptive therapy for those with early symptoms. People around the the United States and Canada can participate to help answer this critically important question. No in-person visits are needed.

This trial is targeting 5 groups of people NATIONWIDE to participate:

  1. If you are symptomatic with a positive COVID-19 test within the first 4 days of symptoms and are not hospitalized; OR
  2. If you live with someone who has been diagnosed with COVID-19, with your last exposure within the last 4 days, and do not have any symptoms; OR
  3. If you live with someone who has been diagnosed with COVID-19, and your symptoms started within the last 4 days; OR
  4. If you have had occupational exposure with known exposure to someone with lab-confirmed COVID-19 within the last 4 days and do not have symptoms; OR
  5. If you have had occupational exposure with known exposure to someone with lab-confirmed COVID-19 within the last 4 days AND have compatible symptoms starting within the last 4 days;

You may participate if you live anywhere in the United States (including territories) or in the Canadian Provinces of Quebec, Manitoba, Alberta, or Ontario.

For information on how to participate in the research trial, go to covidpep.umn.edu or email covid19@umn.edu for instructions. Please check your spam folder if you email.

In Canada, for trial information, please go to: www.covid-19research.ca

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Asymptomatic participants are randomized and analyzed separate from symptomatic participants.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Corona Virus Infection
  • Acute Respiratory Distress Syndrome
  • SARS-CoV Infection
  • Coronavirus
  • Coronavirus Infections
Intervention  ICMJE
  • Drug: 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
    Other Name: Plaquenil
  • Other: Placebo
    4 placebo tablets once, followed in 6 to 8 hours by 3 tablets, then 3 tablets once-a-day for 4 consecutive days
Study Arms  ICMJE
  • Experimental: Treatment
    Participants in this arm will receive the study drug.
    Intervention: Drug: Hydroxychloroquine
  • Placebo Comparator: Placebo
    Participants in this arm will receive a placebo treatment.
    Intervention: Other: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 24, 2020)
1309
Original Estimated Enrollment  ICMJE
 (submitted: March 11, 2020)
1500
Actual Study Completion Date  ICMJE May 20, 2020
Actual Primary Completion Date May 20, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04308668
Other Study ID Numbers  ICMJE MED-2020-28673
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: De-identified dataset will be available within 1 month of publication.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Time Frame: at time of publication
Access Criteria: To be publicly provided
URL: http://covidpep.umn.edu
Responsible Party University of Minnesota
Study Sponsor  ICMJE University of Minnesota
Collaborators  ICMJE
  • McGill University Health Centre/Research Institute of the McGill University Health Centre
  • University of Manitoba
  • University of Alberta
Investigators  ICMJE
Principal Investigator: David Boulware, MD, MPH University of Minnesota
PRS Account University of Minnesota
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP