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

Journal Article · · PLoS ONE
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  1. Friends of Cancer Research, Washington, DC (United States); OSTI
  2. Reagan-Udall Foundation for the FDA, Washington, DC (United States)
  3. Health Catalyst, Salt Lake City, UT (United States)
  4. Gilead Science, Inc. Foster City, CA (United States)
  5. COTA, Inc., Boston, MA (United States)
  6. Syapse, San Francisco, CA (United States)
  7. VA Boston Healthcare System, Boston, MA (United States). Massachusetts Veterans Epidemiology Research and Information Center (MAVERIC); Harvard Medical School, Boston, MA (United States). Brigham and Women's Hospital. Dept. of Medicine
  8. Dascena, Oakland, CA (United States)
  9. Aetion, New York, NY (United States)
  10. VA Boston Healthcare System, Boston, MA (United States). Massachusetts Veterans Epidemiology Research and Information Center (MAVERIC)
  11. John Theurer Cancer Center at Hackensack Univ. Medical Center, Hackensack, NJ (United States). Division of Outcomes and Value Research
  12. Syapse, San Francisco, CA (United States)
  13. VA Connecticut Healthcare System, West Haven, CT (United States); Yale Univ., New Haven, CT (United States). School of Medicine and Public Health
  14. HealthVerity, Philadelphia, PA (United States)
  15. TriNetX, Cambridge, MA (United States)
  16. Gilead Science, Inc., Foster City, CA (United States)
  17. Massachusetts Veteran Epidemiology Research and Information Center (MAVERIC), Boston, MA (United States)
  18. Oak Ridge National Lab. (ORNL), Oak Ridge, TN (United States)
  19. U.S. Food and Drug Administration (FDA), Washington D.C. (United States)
  20. U.S. Food and Drug Administration (FDA), Washington D.C. (United States); Friends of Cancer Research, Washington D.C. (United States)
  21. Friends of Cancer Research, Washington D.C. (United States)
  22. National Inst. for Infectious Diseases Lazzaro Spallanzani, Rome (Italy)
+ Show Author Affiliations
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.
Sponsoring Organization:
USDOE Office of Science (SC)
Grant/Contract Number:
AC05-00OR22725
OSTI ID:
1815877
Journal Information:
PLoS ONE, Journal Name: PLoS ONE Journal Issue: 3 Vol. 16; ISSN 1932-6203
Publisher:
Public Library of ScienceCopyright Statement
Country of Publication:
United States
Language:
English

References (7)

Association of Treatment With Hydroxychloroquine or Azithromycin With In-Hospital Mortality in Patients With COVID-19 in New York State journal June 2020
“Hydroxychloroquine in patients with COVID-19: A Systematic Review and meta-analysis.” journal July 2020
Hydroxychloroquine and azithromycin as a treatment of COVID-19: results of an open-label non-randomized clinical trial journal July 2020
A systematic review on the efficacy and safety of chloroquine for the treatment of COVID-19 journal June 2020
In Vitro Antiviral Activity and Projection of Optimized Dosing Design of Hydroxychloroquine for the Treatment of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) journal March 2020
Projecting the transmission dynamics of SARS-CoV-2 through the postpandemic period journal April 2020
Hydroxychloroquine and tocilizumab therapy in COVID-19 patients—An observational study journal August 2020

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Related Subjects

60 APPLIED LIFE SCIENCES
ACE inhibitor therapy
COVID 19
adverse events
arrhythmia
cancer detection and diagnosis
drug therapy
electrocatalysts
electronic medical records