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History of Changes for Study: NCT04328961
Hydroxychloroquine for COVID-19 PEP
Latest version (submitted December 14, 2021) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 March 29, 2020 None (earliest Version on record)
2 April 16, 2020 Recruitment Status, Contacts/Locations, Study Status, Study Design, Conditions and Sponsor/Collaborators
3 May 12, 2020 Contacts/Locations, Study Status and Study Identification
4 August 10, 2020 Contacts/Locations and Study Status
5 September 3, 2020 Recruitment Status, Study Status, Contacts/Locations and Study Design
6 October 27, 2020 Recruitment Status and Study Status
7 October 8, 2021
Quality Control Review has not concluded Returned: October 12, 2021
Study Status, Outcome Measures, Document Section and Study Design
8 December 14, 2021 Study Status, Outcome Measures, Adverse Events, Participant Flow and Study Design
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Study NCT04328961
Submitted Date:  March 29, 2020 (v1)

Open or close this module Study Identification
Unique Protocol ID: STUDY00009750
Brief Title: Hydroxychloroquine for COVID-19 PEP
Official Title: 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
Secondary IDs:
Open or close this module Study Status
Record Verification: March 2020
Overall Status: Not yet recruiting
Study Start: March 2020
Primary Completion: September 30, 2020 [Anticipated]
Study Completion: October 31, 2020 [Anticipated]
First Submitted: March 23, 2020
First Submitted that
Met QC Criteria:
March 29, 2020
First Posted: April 1, 2020 [Actual]
Last Update Submitted that
Met QC Criteria:
March 29, 2020
Last Update Posted: April 1, 2020 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: University of Washington
Responsible Party: Principal Investigator
Investigator: Ruanne Barnabas
Official Title: Associate Professor, School of Medicine: Global Health
Affiliation: University of Washington
Collaborators: New York University
Bill and Melinda Gates Foundation
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
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.
Open or close this module Conditions
Conditions: COVID-19
Corona Virus Infection
SARS (Severe Acute Respiratory Syndrome)
Keywords: novel coronavirus
post-exposure prophylaxis
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Prevention
Study Phase: Phase 1
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Single (Participant)
Allocation: Randomized
Enrollment: 2000 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Placebo Comparator: Ascorbic Acid
Ascorbic acid 500 mg orally daily for 3 days, then 250 mg orally daily for 11 days
Drug: Ascorbic Acid
Eligible participants in a household randomized to this study arm will receive ascorbic acid therapy.
Other Names:
  • Placebo arm
Experimental: Hydroxychloroquine
Hydrochloroquine 400 mg orally daily for 3 days, then 200 mg orally daily for an additional 11 days
Drug: Hydroxychloroquine Sulfate
Eligible participants in a household randomized to this study arm will receive hydrochloroquine therapy
Other Names:
  • HCQ arm
Open or close this module Outcome Measures
Primary Outcome Measures:
1. 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
2. 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
Secondary Outcome Measures:
1. 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
2. Incidence rates of COVID-19 through study completion
[ Time Frame: 28 days from enrolment ]

PCR-confirmed COVID-19 diagnosis
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 80 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: Yes
Criteria:

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
Open or close this module Contacts/Locations
Central Contact Person: Meighan Krows
Telephone: 206-520-3833
Email: meigs@uw.edu
Central Contact Backup: Justice Quame-Amaglo
Telephone: 206-520-3866
Email: quamaglo@uw.edu
Study Officials: Ruanne V. Barnabas, MBChB, DPhil
Principal Investigator
University of Washington
Anna Bershteyn, PhD
Principal Investigator
NYU Langone Health
Locations: United States, New York
NYU Langone Health
New York, New York, United States, 10016
Contact:Contact: Anna Bershteyn, PhD anna.bershteyn@nyulangone.org
Contact:Principal Investigator: Anna Bershteyn, PhD
United States, Washington
University of Washington, Coordinating Center
Seattle, Washington, United States, 98104
UW Virology Research Clinic
Seattle, Washington, United States, 98104
Contact:Contact: Helen Stankiewicz Karita, MD 206-520-4340 helensk@uw.edu
Contact:Contact: Kirsten Hauge 206-520-4341 kahauge@uw.edu
Contact:Principal Investigator: Christine Johnston, MD
Open or close this module IPDSharing
Plan to Share IPD: Yes
De-identified data from the study will be made available in accordance with the funder's open access policy.
Supporting Information:
Study Protocol
Informed Consent Form (ICF)
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
Open or close this module References
Links:
Available IPD/Information:

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