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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
Results First Posted : May 13, 2021
Last Update Posted : May 13, 2021
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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Corona Virus Infection Acute Respiratory Distress Syndrome SARS-CoV Infection Coronavirus Coronavirus Infections Drug: Hydroxychloroquine Other: Placebo Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1312 participants
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
Official Title: Post-exposure Prophylaxis or Preemptive Therapy for SARS-Coronavirus-2: A Pragmatic Randomized Clinical Trial
Actual Study Start Date : March 17, 2020
Actual Primary Completion Date : May 20, 2020
Actual Study Completion Date : May 20, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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 Name: Plaquenil
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


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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)


Secondary Outcome Measures :
  1. Rate of Hospitalization [ Time Frame: 14 days ]
    Outcome reported as the number of participants in each arm who require hospitalization for COVID19-related disease.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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)

  7. 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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04308668


Locations
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United States, Minnesota
Nationwide Enrollment via Internet, please email: covid19@umn.edu
Minneapolis, Minnesota, United States, 55455
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Canada, Alberta
University of Alberta
Edmonton, Alberta, Canada
Canada, Manitoba
University of Manitoba
Winnipeg, Manitoba, Canada
Canada, Quebec
Research Institute of the McGill University Heath Centre
Montréal, Quebec, Canada
Sponsors and Collaborators
University of Minnesota
McGill University Health Centre/Research Institute of the McGill University Health Centre
University of Manitoba
University of Alberta
Investigators
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Principal Investigator: David Boulware, MD, MPH University of Minnesota
  Study Documents (Full-Text)

Documents provided by University of Minnesota:
Study Protocol and Statistical Analysis Plan  [PDF] May 24, 2020
Informed Consent Form  [PDF] April 24, 2020

More Information
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Study Data/Documents: Individual Participant Data Set  This link exits the ClinicalTrials.gov site

Publications of Results:

Other Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT04308668    
Other Study ID Numbers: MED-2020-28673
First Posted: March 16, 2020    Key Record Dates
Results First Posted: May 13, 2021
Last Update Posted: May 13, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified dataset will be available within 1 month of publication.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: at time of publication
Access Criteria: To be publicly provided. Please register at the website to receive the dataset.
URL: https://covidpep.umn.edu/data

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Minnesota:
COVID-19
Corona Virus
SARS-COV-2
Coronavirus
Additional relevant MeSH terms:
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Infections
Communicable Diseases
Coronavirus Infections
COVID-19
Respiratory Distress Syndrome
Respiratory Distress Syndrome, Newborn
Acute Lung Injury
Disease Attributes
Pathologic Processes
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Lung Diseases
Respiratory Tract Diseases
 Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury
Respiratory Tract Infections
Pneumonia, Viral
Pneumonia
Hydroxychloroquine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents