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

COVID-19 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04328961
• Other study ID #: STUDY00009750
• Secondary ID: INV-016204
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: March 31, 2020
• Est. completion date: October 8, 2020

Study information

• Verified date: December 2021
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 943
• Est. completion date: October 8, 2020
• Est. primary completion date: September 24, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Corona Virus Infection
• Coronavirus Infections
• COVID-19
• Infections
• SARS (Severe Acute Respiratory Syndrome)
• SARS-CoV-2
• Severe Acute Respiratory Syndrome
• Syndrome

Intervention

Drug:
• Hydroxychloroquine Sulfate
Eligible participants in a household randomized to this study arm will receive hydrochloroquine therapy
• Ascorbic Acid
Eligible participants in a household randomized to this study arm will receive ascorbic acid therapy.

Locations

Country	Name	City	State
United States	University of Maryland, Baltimore	Baltimore	Maryland
United States	Boston University	Boston	Massachusetts
United States	University of California Los Angeles	Los Angeles	California
United States	Tulane	New Orleans	Louisiana
United States	NYU Langone Health	New York	New York
United States	University of Washington, Coordinating Center	Seattle	Washington
United States	UW Virology Research Clinic	Seattle	Washington
United States	SUNY Upstate Medical University	Syracuse	New York

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	Bill and Melinda Gates Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Rate of Participant-reported Adverse Events	Safety and tolerability of Hydroxychloroquine as SARS-CoV-2 PEP in adults	28 days from start of Hydroxychloroquine therapy
Secondary	Number of Participants Who Had COVID-19 Disease	Participants who had a PCR-confirmed SARS-CoV-2 infection and met the Center for Disease Control (CDC) defined criteria for symptomatic COVID-19 disease.	28 days from enrolment