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Hydroxychloroquine for COVID-19 Post-exposure Prophylaxis (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: NCT04328961
Recruitment Status : Completed
First Posted : April 1, 2020
Last Update Posted : October 29, 2020
Sponsor:
Collaborator:
Bill and Melinda Gates Foundation
Information provided by (Responsible Party):
Ruanne Barnabas, University of Washington

Tracking Information
First Submitted Date  ICMJE March 23, 2020
First Posted Date  ICMJE April 1, 2020
Last Update Posted Date October 29, 2020
Actual Study Start Date  ICMJE March 31, 2020
Actual Primary Completion Date September 24, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 29, 2020)
  • Polymerase chain reaction (PCR) confirmed SARS-CoV-2 infection [ Time Frame: Day 1 through Day 14 after enrolment ]
    Polymerase chain reaction (PCR) confirmed SARS-CoV-2 infection from self-collected samples collected daily for 14 days
  • Polymerase chain reaction (PCR) confirmed SARS-CoV-2 infection [ Time Frame: Day 28 after enrolment ]
    Polymerase chain reaction (PCR) confirmed SARS-CoV-2 infection from self-collected samples collected at study exit
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 29, 2020)
  • Rate of participant-reported adverse events [ Time Frame: 28 days from start of Hydroxychloroquine therapy ]
    Safety and tolerability of Hydroxychloroquine as SARS-CoV-2 PEP in adults
  • Incidence rates of COVID-19 through study completion [ Time Frame: 28 days from enrolment ]
    PCR-confirmed COVID-19 diagnosis
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Hydroxychloroquine for COVID-19 Post-exposure Prophylaxis (PEP)
Official Title  ICMJE Efficacy of Hydroxychloroquine for Post-exposure Prophylaxis (PEP) to Prevent Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection Among Adults Exposed to Coronavirus Disease (COVID-19): a Blinded, Randomized Study
Brief Summary This is a clinical study for the prevention of SARS-CoV-2 infection in adults exposed to the virus. This study will enroll up to 2000 asymptomatic men and women 18 to 80 years of age (inclusive) who are close contacts of persons with laboratory confirmed SARS-CoV-2 or clinically suspected COVID-19. Eligible participants will be enrolled and randomized to receive the intervention or placebo at the level of the household (all eligible participants in one household will receive the same intervention).
Detailed Description This is a randomized, multi-center, placebo-equivalent (ascorbic acid) controlled, blinded study of Hydroxychloroquine (HCQ) post-exposure prophylaxis (PEP) for the prevention of SARS-CoV-2 infection in adults exposed to the virus.The overarching goal of this study is to assess the effectiveness of HCQ PEP on the incidence of SARS-CoV-2 detection by polymerase chain reaction (PCR) to inform public health control strategies.This study will enroll up to 2000 asymptomatic men and women 18 to 80 years of age (inclusive) at baseline who are close contacts of persons with PCR-confirmed SARS-CoV-2 or clinically suspected COVID-19 and a pending SARS-CoV-2 PCR test. Eligible participants will be enrolled and randomized 1:1 to HCQ or ascorbic acid at the level of the household (all eligible participants in one household will receive the same intervention). Participants will be counseled about the preliminary in vitro data on HCQ activity against SARS CoV-2 and equipoise regarding efficacy in humans.The duration of study participation will be approximately 28 days.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE
  • COVID-19
  • Corona Virus Infection
  • SARS (Severe Acute Respiratory Syndrome)
  • SARS-CoV-2
Intervention  ICMJE
  • Drug: Hydroxychloroquine Sulfate
    Eligible participants in a household randomized to this study arm will receive hydrochloroquine therapy
    Other Name: HCQ arm
  • Drug: Ascorbic Acid
    Eligible participants in a household randomized to this study arm will receive ascorbic acid therapy.
    Other Name: Placebo arm
Study Arms  ICMJE
  • Placebo Comparator: Ascorbic Acid
    Ascorbic acid 500 mg orally daily for 3 days, then 250 mg orally daily for 11 days
    Intervention: Drug: Ascorbic Acid
  • Experimental: Hydroxychloroquine
    Hydrochloroquine 400 mg orally daily for 3 days, then 200 mg orally daily for an additional 11 days
    Intervention: Drug: Hydroxychloroquine Sulfate
Publications * Barnabas RV, Brown E, Bershteyn A, Miller RS, Wener M, Celum C, Wald A, Chu H, Wesche D, Baeten JM; Hydroxychloroquine COVID-19 PEP Study Team. Efficacy of hydroxychloroquine for post-exposure prophylaxis to prevent severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection among adults exposed to coronavirus disease (COVID-19): a structured summary of a study protocol for a randomised controlled trial. Trials. 2020 Jun 3;21(1):475. doi: 10.1186/s13063-020-04446-4.

*   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: September 3, 2020)
829
Original Estimated Enrollment  ICMJE
 (submitted: March 29, 2020)
2000
Actual Study Completion Date  ICMJE October 8, 2020
Actual Primary Completion Date September 24, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Men or women 18 to 80 years of age inclusive, at the time of signing the informed consent
  • Willing and able to provide informed consent
  • Had a close contact of a person (index) with known PCR-confirmed SARS-CoV-2 infection or who is currently being assessed for COVID-19. Close contact defined as:

    1. Household contact (i.e., residing with the index case in the 14 days prior to index diagnosis)
    2. Medical staff, first responders, or other care persons who cared for the index case without personal protection (mask and gloves)
  • Less than 4 days since last exposure (close contact with a person with SARS-CoV-2 infection) to the index case
  • Body weight < 100 kg (self-reported)
  • Access to device and internet for Telehealth visits

Exclusion Criteria:

  • Known hypersensitivity to HCQ or other 4-aminoquinoline compounds
  • Currently hospitalized
  • Symptomatic with subjective fever, cough, or sore throat
  • Current medications exclude concomitant use of HCQ
  • Concomitant use of other anti-malarial treatment or chemoprophylaxis
  • History of retinopathy of any etiology
  • Psoriasis
  • Porphyria
  • Known bone marrow disorders with significant neutropenia (polymorphonuclear leukocytes < 1500) or thrombocytopenia (< 100 K)
  • Concomitant use of digoxin, cyclosporin, cimetidine, or tamoxifen
  • Known liver disease
  • Known long QT syndrome
  • Use of any investigational or non-registered drug or vaccine within 30 days preceding the first dose of the study drugs, or planned use during the study period
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04328961
Other Study ID Numbers  ICMJE STUDY00009750
INV-016204 ( Other Grant/Funding Number: Bill and Melinda Gates Foundation )
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
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: De-identified data from the study will be made available in accordance with the funder's open access policy.
Supporting Materials: Study Protocol
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Analytic Code
Time Frame: Within 3 months of publication of primary results.
Access Criteria: De-identified data from the study will be made available in accordance with the funder's open access policy.
URL: https://www.gatesfoundation.org/how-we-work/general-information/open-access-policy
Responsible Party Ruanne Barnabas, University of Washington
Study Sponsor  ICMJE University of Washington
Collaborators  ICMJE Bill and Melinda Gates Foundation
Investigators  ICMJE
Principal Investigator: Ruanne V. Barnabas, MBChB, DPhil University of Washington
PRS Account University of Washington
Verification Date October 2020

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