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

This study will enroll up to 2000 asymptomatic adults 18 to 80 years of age (inclusive) at baseline who are close contacts of persons with polymerase chain reaction (PCR)-confirmed SARS-CoV-2 or clinically suspected COVID-19 and a pending SARS-CoV-2 PCR test. This multisite trial will be conducted at seven sites in Seattle (UW), Los Angeles (UCLA), New Orleans (Tulane), Baltimore (UMB), New York City (NYU), Syracuse (SUNY-Upstate), and Boston (BMC).Inclusion criteriaParticipants are eligible to be included in the study only if all of the following criteria apply:Men or women 18 to 80 years of age inclusive, at the time of signing the informed consentWilling and able to provide informed consentHad a close contact of a person (index) with known PCR-confirmed SARS-CoV-2 infection or index who is currently being assessed for COVID-19Close contact is defined as:Household contact (i.e., residing with the index case in the 14 days prior to index diagnosis or prolonged exposure within a residence/vehicle/enclosed space without maintaining social distance)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 caseAccess to device and internet for Telehealth visitsNot planning to take HCQ in addition to the study medicationExclusion criteriaParticipants are excluded from the study if any of the following crit...
Source: Trials - Category: Research Source Type: clinical trials