Hydroxychloroquine for COVID-19 Post-exposure Prophylaxis (PEP)

NCT04328961 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: STUDY00009750INV-016204
• Study Type: interventional
• Target: 943
• Locations: 1 country
• Sites: 8

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).

Conditions

COVID-19; Corona Virus Infection; SARS (Severe Acute Respiratory Syndrome); SARS-CoV-2

Keywords

novel coronavirus; post-exposure prophylaxis

Outcome Measures

Primary Outcomes (2)

• Number of Participants Who Had Polymerase Chain Reaction (PCR) Confirmed SARS-CoV-2 Infection

  Polymerase chain reaction (PCR) confirmed severe acute respiratory syndrome coronavirus 2 of the genus Betacoronavirus (SARS-CoV-2) infection from self-collected samples collected daily for 14 days

  Day 1 through Day 14 after enrolment

• The Number of Participants Who Had Polymerase Chain Reaction (PCR) Confirmed SARS-CoV-2 Infection

  Polymerase chain reaction (PCR) confirmed SARS-CoV-2 infection from self-collected samples collected at study exit

  Day 28 after enrolment

Secondary Outcomes (2)

• Rate of Participant-reported Adverse Events

  28 days from start of Hydroxychloroquine therapy

• Number of Participants Who Had COVID-19 Disease

  28 days from enrolment

Study Arms (2)

Ascorbic Acid

PLACEBO COMPARATOR

Ascorbic acid 500 mg orally daily for 3 days, then 250 mg orally daily for 11 days

Drug: Ascorbic Acid

Hydroxychloroquine

EXPERIMENTAL

Hydrochloroquine 400 mg orally daily for 3 days, then 200 mg orally daily for an additional 11 days

Drug: Hydroxychloroquine Sulfate

Interventions

Hydroxychloroquine Sulfate DRUG

Eligible participants in a household randomized to this study arm will receive hydrochloroquine therapy

Also known as: HCQ arm

Hydroxychloroquine

Ascorbic Acid DRUG

Eligible participants in a household randomized to this study arm will receive ascorbic acid therapy.

Also known as: Placebo arm

Ascorbic Acid

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Household contact (i.e., residing with the index case in the 14 days prior to index diagnosis)
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead
• Bill and Melinda Gates Foundation: collaborator

Study Sites (8)

University of California Los Angeles

Los Angeles, California, 90095, United States

Location

Tulane

New Orleans, Louisiana, 70118, United States

Location

University of Maryland, Baltimore

Baltimore, Maryland, 21201, United States

Location

Boston University

Boston, Massachusetts, 02215, United States

Location

NYU Langone Health

New York, New York, 10016, United States

Location

SUNY Upstate Medical University

Syracuse, New York, 13210, United States

Location

University of Washington, Coordinating Center

Seattle, Washington, 98104, United States

Location

UW Virology Research Clinic

Seattle, Washington, 98104, United States

Location

Related Publications (2)

• Barnabas RV, Brown ER, Bershteyn A, Stankiewicz Karita HC, Johnston C, Thorpe LE, Kottkamp A, Neuzil KM, Laufer MK, Deming M, Paasche-Orlow MK, Kissinger PJ, Luk A, Paolino K, Landovitz RJ, Hoffman R, Schaafsma TT, Krows ML, Thomas KK, Morrison S, Haugen HS, Kidoguchi L, Wener M, Greninger AL, Huang ML, Jerome KR, Wald A, Celum C, Chu HY, Baeten JM; Hydroxychloroquine COVID-19 PEP Study Team. Hydroxychloroquine as Postexposure Prophylaxis to Prevent Severe Acute Respiratory Syndrome Coronavirus 2 Infection : A Randomized Trial. Ann Intern Med. 2021 Mar;174(3):344-352. doi: 10.7326/M20-6519. Epub 2020 Dec 8.

  PMID: 33284679 DERIVED

• 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.

  PMID: 32493478 DERIVED

MeSH Terms

Conditions

COVID-19; Coronavirus Infections; Severe Acute Respiratory Syndrome

Interventions

Hydroxychloroquine; Ascorbic Acid

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chloroquine; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Results Point of Contact

• Title: Ruanne Barnabas
• Organization: University of Washington

rbarnaba@uw.edu

206 520 3800

Study Officials

• Ruanne V. Barnabas, MBChB, DPhil

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, School of Medicine: Global Health

Study Record Dates

• First Submitted: March 23, 2020
• First Posted: April 1, 2020
• Study Start: March 31, 2020
• Primary Completion: September 24, 2020
• Study Completion: October 8, 2020
• Last Updated: December 16, 2021
• Results First Posted: December 16, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, 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.

Locations

US (8)