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

May 11, 2021 updated by: University of Minnesota

Post-exposure Prophylaxis or Preemptive Therapy for SARS-Coronavirus-2: A Pragmatic Randomized Clinical Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

1312

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada
        • University of Alberta
    • Manitoba
      • Winnipeg, Manitoba, Canada
        • University of Manitoba
    • Quebec
      • Montréal, Quebec, Canada
        • Research Institute of the McGill University Heath Centre
  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Nationwide Enrollment via Internet, please email: covid19@umn.edu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Participants in this arm will receive a placebo treatment.
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
EXPERIMENTAL: Treatment
Participants in this arm will receive the study drug.
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 Names:
  • Plaquenil

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Active COVID-19 Disease at Day 14 Among Those Who Were Asymptomatic at Baseline
Time Frame: 14 days
Number of participants at 14 days post enrollment with active COVID19 disease among those who were asymptomatic at baseline.
14 days
Change in Disease Severity Over 14 Days Among Those Who Are Symptomatic at Baseline
Time Frame: baseline and 14 days
Visual Analog Scale 0-10 score of rating overall symptom severity (0 = no symptoms; 10 = most severe)
baseline and 14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Hospitalization
Time Frame: 14 days
Outcome reported as the number of participants in each arm who require hospitalization for COVID19-related disease.
14 days
Rate of Death
Time Frame: Approximately 30 days
Outcome reported as the number of participants in each arm who expire due to COVID-19-related disease through study completion of 14 days. For those hospitalized within the 14-day study period, the protocol specified follow up would occur for up to 90 days to capture the final outcome of participants' hospitalization. Approximately 30-days was the maximal follow up for hospitalization outcome needed in the trial.
Approximately 30 days
Rate 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.
14 days
Occurrence of Symptoms Compatible With COVID-19 (Possible Disease)
Time Frame: 14 days
Outcome reported as the number of participants in each arm who self-report symptoms compatible with COVID-19 infection.
14 days
Rate 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.
14 days
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)
5 and 14 days
Number of Participants With Severe COVID-19 Disease 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 number of participants who report a score of 3.
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Minnesota

Collaborators

University of Manitoba
University of Alberta
McGill University Health Centre/Research Institute of the McGill University Health Centre

Investigators

  • Principal Investigator: David Boulware, MD, MPH, University of Minnesota

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 17, 2020

Primary Completion (ACTUAL)

May 20, 2020

Study Completion (ACTUAL)

May 20, 2020

Study Registration Dates

First Submitted

March 11, 2020

First Submitted That Met QC Criteria

March 11, 2020

First Posted (ACTUAL)

March 16, 2020

Study Record Updates

Last Update Posted (ACTUAL)

May 13, 2021

Last Update Submitted That Met QC Criteria

May 11, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MED-2020-28673

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified dataset will be available within 1 month of publication.

IPD Sharing Time Frame

at time of publication

IPD Sharing Access Criteria

To be publicly provided. Please register at the website to receive the dataset.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Study Data/Documents

  1. Individual Participant Data Set

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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