DOI: 10.3886/icpsr38819.v1
title: Healthcare Worker Exposure Response and Outcomes of Hydroxychloroquine Trial (HERO-HCQ Trial), United States, 2020-2021
title: Version 1

description: Severe acute respiratory syndrome coronavirus 2 associated disease (COVID-19) is caused by a novel betacoronavirus, SARS-CoV-2, that was first isolated in January 2020 and has since caused a global pandemic unseen in decades in cases and mortality. At the time of initial protocol submission in April 2020, human vaccine clinical trials had just begun and experts predicted that a vaccine would not be available until April 2021 at the earliest. Therefore, new measures remained needed to prevent the spread of disease. In vitro studies suggested a potential moderate antiviral effect of hydroxychloroquine (HCQ). This study aimed to evaluate the efficacy of HCQ to prevent COVID-19 clinical infection and to prevent viral shedding of SARS-CoV-2 among healthcare workers (HCWs), as well as to evaluate the safety and tolerability of HCQ. Participants prescreened through the Healthcare Exposure Response and Outcomes (HERO) Registry across 34 U.S. clinical centers were randomly assigned to take a placebo (n=676) or HCQ (n=683) for 30 days, with in-person clinic visits at baseline and 30 days, and an end-of-study virtual visit at 60 days. This collection contains analysis (DS1 through DS6) and tabulation (DS7 through DS44) data and accompanying documentation.
description: The primary objective of the study was to evaluate the efficacy of hydroxychloroquine (HCQ) in preventing COVID-19 infection in healthcare workers when taken daily. Secondary objectives were to assess the efficacy of HCQ in preventing asymptomatic viral shedding of the COVID-19 virus (SARS-CoV-2) and to assess the safety and tolerability of HCQ among healthcare workers.
description: The Healthcare Worker Exposure Response and Outcomes of Hydroxychloroquine (HERO-HCQ) Trial was a multi-site (34 U.S. clinical sites), double-blind, randomized, parallel-group study. Study recruitment and enrollment occurred between April and November 2020. Once participants were determined to be eligible during pre-screening, they were randomly assigned (1:1), stratified by site, to the treatment group (HCQ) or placebo group. HCQ dosage was a 600 mg loading dose for day 1, followed by 400 mg daily via oral self-administration for 29 days. Baseline assessments were conducted during in-person visits; participants had blood drawn and received a nasal swab to test for COVID-19 infection. Each week, participants completed follow-ups through an online portal, answering items about COVID-19 symptoms, clinical events, adverse events, and quality of life assessments. In cases of missed follow-ups or clinic visits, study sites and call centers attempted to contact the participant. At the 30 day mark, participants completed a second on-site visit to assess study drug adherence and to provide a nasal swab and blood draw to check for COVID-19 infection. At the 60 day mark, a virtual end-of-study visit was conducted via the online portal or call center.
description: Primary outcome: confirmed or suspected clinical infection with COVID-19 before 30 days, determined by COVID-19 consistent symptoms (fever, cough, etc.) or positive test result Clinical measures: height, weight, temperature, medical history (e.g., prior diagnosis of any conditions and current or prior medications taken), presence of COVID-19 infection/antibodies via swab or serology, report of any COVID-19 symptoms Quality of life items: level of burnout, emotional distress, depression symptoms Participant demographic items: sex, age, race, ethnicity, height, weight, BMI, and role in healthcare setting Events that occurred during the study: Adverse events, healthcare encounters, other clinical events
description: Response Rates: Of the 683 participants in the HCQ treatment group, 665 (97.4%) completed the day 30 visit, and 607 (88.9%) completed the day 60 visit. 610 individuals completed the study, 63 were lost to follow-up, and 10 withdrew consent. Of the 677 participants in the placebo group, 651 (96.2%) completed the day 30 visit, and 604 (89.7%) completed the day 60 visit. 607 individuals completed the study, 57 were lost to follow-up, 12 withdrew consent, and 1 was withdrawn from the study due to physician decision.
description: Presence of Common Scales: Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress-Anxiety Short Form Patient Health Questionnaire-2 (PHQ-2) Single Item Burnout Measure
description: The research team used the Healthcare Worker Exposure Response and Outcomes (HERO) Registry to facilitate study recruitment. Eligibility criteria for participation in this trial were adults 18 years and older who were working in a healthcare setting with potential exposure to patients with COVID-19 infections. Individuals who had a prior diagnosis of COVID-19, known allergies to HCQ or chloroquine, who were currently using or planned to use HCQ for any indication, or were participating in another COVID-19 trial. 1,360 individuals were screened and randomized into placebo (n=677) and treatment (n=683) conditions. The average age of participants was 43.6 years. 65.3% of participants were female, 90.8% were White, and 5.8% reported Hispanic/Latino ethnicity.
description: Datasets: DS0: Study-Level Files DS1: Subject-Level Analysis Dataset DS2: Analysis Dataset Adverse Events DS3: Analysis Dataset Labs DS4: Analysis Dataset COVID-19 Questionnaire DS5: Analysis Dataset Quality of Life (QOL) Questionnaire DS6: Analysis Dataset Clinical Event DS7: Trial Arms DS8: Trial Elements DS9: Trial Inclusion/Exclusion Criteria DS10: Trial Summary DS11: Trial Visits DS12: Demographics DS13: Subject Elements DS14: Subject Visits DS15: Concomitant/Prior Medications DS16: Exposure as Collected DS17: Exposure DS18: Procedures DS19: Adverse Events DS20: Clinical Events DS21: Disposition DS22: Protocol Deviations DS23: Healthcare Encounters DS24: Medical History DS25: Drug Accountability DS26: Findings About Events or Interventions (COVID-19 Questions) DS27: Inclusion/Exclusion Criteria Not Met DS28: Laboratory Test Results DS29: Burnout Questionnaire DS30: Call Center Questionnaire DS31: Employment Characteristics DS32: Patient Health Questionnaire (PHQ-2) DS33: PROMIS Emotional Distress-Anxiety Short Form DS34: Vital Signs DS35: Supplemental Qualifiers for Adverse Events (AE) DS36: Supplemental Qualifiers for Clinical Events (CE) DS37: Supplemental Qualifiers for Demographics (DM) DS38: Supplemental Qualifiers for Disposition (DS) DS39: Supplemental Qualifiers for Protocol Deviations (DV) DS40: Supplemental Qualifiers for Exposure as Collected (EC) DS41: Supplemental Qualifiers for Healthcare Encounters (HO) DS42: Supplemental Qualifiers for Laboratory Test Results (LB) DS43: Supplemental Qualifiers for Employment Characteristics (QSEC) DS44: Related Records
description: Healthcare workers aged 18 and older who, at the time of study, were working in any environment in which there was a risk of exposure to patients with COVID-19 infections.
description: coded on-site observation; web-based surveyThe participant ID variable <strong>DEIDNUM</strong> can be used to link datasets, with the exception of trial-level data (DS7 through DS11).For more information on the HERO-HCQ trial, please visit the study website.