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

University of Washington

Status and phase: Completed; Phase 3; Phase 2

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

Treatments: Drug: Hydroxychloroquine Sulfate; Drug: Ascorbic Acid

Study type: Interventional

Funder types: Other

Identifiers

NCT04328961

INV-016204 (Other Grant/Funding Number)

STUDY00009750

Details and patient eligibility

About

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).

Full 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.

Enrollment: 943 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

943 participants in 2 patient groups, including a placebo group

Ascorbic Acid

Placebo Comparator group

Description:

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

Treatment:

Drug: Ascorbic Acid

Hydroxychloroquine

Experimental group

Description:

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

Treatment:

Drug: Hydroxychloroquine Sulfate