NCT04328961

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

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 943 (actual)
• Sponsor: University of Washington · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

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.

Conditions

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

Interventions

Type	Name	Description
DRUG	Hydroxychloroquine Sulfate	Eligible participants in a household randomized to this study arm will receive hydrochloroquine therapy
DRUG	Ascorbic Acid	Eligible participants in a household randomized to this study arm will receive ascorbic acid therapy.

Timeline

• Start date: 2020-03-31
• Primary completion: 2020-09-24
• Completion: 2020-10-08
• First posted: 2020-04-01
• Last updated: 2021-12-16
• Results posted: 2021-12-16

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated drug study