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Open-label randomized control trial of hydroxychloroquine in patients with moderate to severe coronavirus disease 2019 infection.

Authors
  • Gupta, Salil1
  • Dixit, Prashant Kumar2
  • Ghana, Parthasarathi3
  • Abhisheka, Kumar4
  • Khurana, Harshit5
  • Jha, Vijoy Kumar6
  • Mahapatra, Debasish7
  • Goel, Jitesh8
  • Ahmed, Safia9
  • Varadaraj, G10
  • 1 Consultant & Head (Medicine & Neurology), Command Hospital (Air Force), Bengaluru, India. , (India)
  • 2 Graded Specialist (Medicine), Command Hospital (Air Force), Bengaluru, India. , (India)
  • 3 Commanding Officer, Air Force Hospital, Gorakhpur, India. , (India)
  • 4 Senior Advisor (Medicine & Endocrinology), Command Hospital (Air Force), Bengaluru, India. , (India)
  • 5 Senior Advisor (Medicine & Haematology), Command Hospital (Southern Command), Pune, India. , (India)
  • 6 Classified Specialist (Medicine & Nephrology), Command Hospital (Air Force), Bengaluru, India. , (India)
  • 7 Senior Advisor (Medicine & Nephrology), 7 Air Force Hospital, Kanpur, India. , (India)
  • 8 Senior Advisor (Medicine & Neurology), Command Hospital (Air Force), Bengaluru, India. , (India)
  • 9 Classified Specialist (Pulmonology), Command Hospital (Air Force), Bengaluru, India. , (India)
  • 10 Classified Specialist (Medicine), Command Hospital (Air Force), Bengaluru, India. , (India)
Type
Published Article
Journal
Medical Journal Armed Forces India
Publisher
Elsevier
Publication Date
Jul 01, 2021
Volume
77
Identifiers
DOI: 10.1016/j.mjafi.2021.02.007
PMID: 34334898
Source
Medline
Keywords
Language
English
License
Unknown

Abstract

At onset of coronavirus disease 2019 (COVID-19) pandemic, hydroxychloroquine (HCQ) was repurposed for treatment of patients based on reports that it had in vitro activity. The aim of this study was to find out if HCQ reduces number of days of hospitalization when given to patients with moderate to severe COVID-19 infections who require hospitalized care. This was an open-label randomized control trial of HCQ administered 400 mg twice on day 1, then 400 mg once daily from day 2 to day 5 in patients with moderate to severe COVID-19 infection. Assessment was not blinded. Standard of care was given to both arms.Primary outcome was number of days of hospitalization till discharge or death. One hundred ten patients (55 in each arm) were included. Mean age was 58 years. Baseline characteristics were well matched. There was no difference in the primary outcome (13.67 vs 13.89; p = 0.98). Number of deaths were more in HCQ arm (RR: 1.81; 95% CI: 1.13-2.93; p = 0.03). There was no difference in number of days on oxygen or normalization of oxygen saturation, number who needed ventilator, days to ventilator requirement and days on ventilator. Twenty-nine patients in control arm received remdesivir. When adjusted analysis was done after removal of these patients, there was no difference in primary or secondary outcomes. Number of deaths in adjusted analysis were not significant (RR: 1.28; 95% CI: 0.87-1.88; p = 0.37). HCQ does not change the number of days of hospitalization when compared with control. © 2021 Director General, Armed Forces Medical Services. Published by Elsevier, a division of RELX India Pvt. Ltd.

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