ABSTRACT
ObjectiveTo determine whether hydroxychloroquine (HCQ) is safe and effective at preventing COVID-19 infections among health care workers (HCW). DesignMulticenter, 1:1 randomized, placebo-controlled, double-blind, parallel-group, superiority trial. Setting34 clinical centers in the United States. Participants1360 HCW at risk for COVID-19 infection enrolled between April and November 2020. InterventionsA loading dose of HCQ 600 mg twice on Day 1 followed by 400 mg daily for 29 days or matching placebo taken orally. Main Outcome MeasureComposite of confirmed or suspected COVID-19 clinical infection by Day 30 defined as new onset fever, cough, or dyspnea and either a positive SARS-CoV-2 PCR test (confirmed) or a lack of confirmatory testing due to local restrictions (suspected). ResultsEnrollment for the study was closed before full accrual due to difficulties recruiting additional participants. The primary composite endpoint occurred in 41 (6.0%) participants receiving HCQ and 53 (7.8%) participants receiving placebo. No statistically significant difference in the proportion of participants experiencing clinical infection (estimated difference of -1.8%, 95% confidence interval -4.6% to 0.9%, p=0.20). We identified no significant safety issues. ConclusionOral HCQ taken as prescribed appeared to be safe in a group of HCW. No significant clinical benefits were observed. The study was underpowered to rule out a small but potentially important reduction in COVID-19 infections. Trial RegistrationNCT04334148
ABSTRACT
IntroductionEarly COVID-19 vaccine acceptance rates suggest that up to one-third of HCWs may be vaccine-hesitant. However, it is unclear whether hesitancy among HCWs has improved with time and if there are temporal changes whether these differ by healthcare worker role. MethodsIn October 2020, a brief survey was sent to all participants in the Healthcare Worker Exposure Response and Outcomes (HERO) Registry with a yes/no question regarding vaccination under emergency use authorization (EUA): "If an FDA emergency use-approved vaccine to prevent coronavirus/COVID-19 was available right now at no cost, would you agree to be vaccinated?" The poll was repeated in December 2020, with the same question sent to all registry participants. Willingness was defined as a "Yes" response, and hesitancy was defined as a "No" response. Participants were stratified into clinical care roles. Baseline demographics of survey respondents at each timepoint were compared using appropriate univariate statistics (chi-squared and t-tests). Analyses were descriptive, with frequencies and percentages reported for each category. ResultsOf 4882 HERO active registry participants during September 1 - October 31, 2020, 2070 (42.4%) completed the October survey, and n=1541 (31.6%) completed the December survey. 70.2% and 67.7% who were in clinical care roles, respectively. In October, 54.2% of HCWs in clinical roles said they would take an EUA-approved vaccine, which increased to 76.2% in December. The largest gain in vaccine willingness was observed among physicians, 64.0% of whom said they would take a vaccine in October, compared with 90.5% in December. Nurses were the least likely to report that they would take a vaccine in both October (46.6%) and December (66.9%). We saw no statistically significant differences in age, race/ethnicity, gender, or medical role between time points. When restricting to the 998 participants who participated at both time points, 69% were vaccine-willing at both time points; 15% were hesitant at both time points, 13% who were hesitant in October were willing in December; and 2.9% who were willing in October were hesitant in December. ConclusionsIn a set of cross-sectional surveys of vaccine acceptance among healthcare workers, willingness improved substantially over 2 calendar months during which the US had a presidential election and two vaccine manufacturers released top-line Phase 3 trial results. While improved willingness was observed in all role categories, nurses reported the most vaccine hesitancy at both time points.
