COVID-19 Evidence Accelerator: A parallel analysis to describe the use of Hydroxychloroquine with or without Azithromycin among hospitalized COVID-19 patients.

BACKGROUND

The COVID-19 pandemic remains a significant global threat. However, despite urgent need, there remains uncertainty surrounding best practices for pharmaceutical interventions to treat COVID-19. In particular, conflicting evidence has emerged surrounding the use of hydroxychloroquine and azithromycin, alone or in combination, for COVID-19. The COVID-19 Evidence Accelerator convened by the Reagan-Udall Foundation for the FDA, in collaboration with Friends of Cancer Research, assembled experts from the health systems research, regulatory science, data science, and epidemiology to participate in a large parallel analysis of different data sets to further explore the effectiveness of these treatments.

METHODS

Electronic health record (EHR) and claims data were extracted from seven separate databases. Parallel analyses were undertaken on data extracted from each source. Each analysis examined time to mortality in hospitalized patients treated with hydroxychloroquine, azithromycin, and the two in combination as compared to patients not treated with either drug. Cox proportional hazards models were used, and propensity score methods were undertaken to adjust for confounding. Frequencies of adverse events in each treatment group were also examined.

RESULTS

Neither hydroxychloroquine nor azithromycin, alone or in combination, were significantly associated with time to mortality among hospitalized COVID-19 patients. No treatment groups appeared to have an elevated risk of adverse events.

CONCLUSION

Administration of hydroxychloroquine, azithromycin, and their combination appeared to have no effect on time to mortality in hospitalized COVID-19 patients. Continued research is needed to clarify best practices surrounding treatment of COVID-19.

Déclaration de conflit d'intérêts

The authors have read the journal’s policy and the authors of this manuscript have the following competing interests: AA is a paid employee and stockholder at Health Catalyst. JA is a paid employee and stockholder at Gilead Sciences. AB is a paid employee of COTA, Inc with ownership interest (equity). TB is a paid employee of Sypase. NG is a paid employee and shareholder of Aetion, Inc. SG has equity ownership with COTA, Inc. EH is a paid employee by COTA, Inc. with ownership interest (equity). JH is Founder and President of Syapse with pharmaceutical company funders including Roche, Amgen, Merck & Co. (Syapse employees engaged in design, collection, analysis, interpretation, writing, and the decision to submit for publication). JH also reported being an advisor for Freenome. MI is a paid employee of Syapse. SK is a paid employee of TriNetX, LLC. RM is a paid employee and shareholder of Gilead Sciences. JR is a paid employee of and shareholder in Aetion, Inc., a company that makes software for the analysis of real-world data. AW is an employee and shareholder of Aetion, Inc., a company that makes software for the analysis of real-world data. This does not alter our adherence to PLOS One policies on sharing data and material. There are no patents, products in development, or marketed products associated with this research to declare.