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A multicenter, randomized, open-label, controlled trial to evaluate the efficacy and tolerability of hydroxychloroquine and a retrospective study in adult patients with mild to moderate coronavirus disease 2019 (COVID-19).


ABSTRACT: Objective: In this study, we evaluated the efficacy of hydroxychloroquine (HCQ) against coronavirus disease 2019 (COVID-19) via a randomized controlled trial (RCT) and a retrospective study.

Methods: Subjects admitted to 11 designated public hospitals in Taiwan between April 1 and May 31, 2020, with COVID-19 diagnosis confirmed by pharyngeal real-time RT-PCR for SARS-CoV-2, were randomized at a 2:1 ratio and stratified by mild or moderate illness. HCQ (400 mg twice for 1 d or HCQ 200 mg twice daily for 6 days) was administered. Both the study and control group received standard of care (SOC). Pharyngeal swabs and sputum were collected every other day. The proportion and time to negative viral PCR were assessed on day 14. In the retrospective study, medical records were reviewed for patients admitted before March 31, 2020.

Results: There were 33 and 37 cases in the RCT and retrospective study, respectively. In the RCT, the median times to negative rRT-PCR from randomization to hospital day 14 were 5 days (95% CI; 1, 9 days) and 10 days (95% CI; 2, 12 days) for the HCQ and SOC groups, respectively (p = 0.40). On day 14, 81.0% (17/21) and 75.0% (9/12) of the subjects in the HCQ and SOC groups, respectively, had undetected virus (p = 0.36). In the retrospective study, 12 (42.9%) in the HCQ group and 5 (55.6%) in the control group had negative rRT-PCR results on hospital day 14 (p = 0.70).

Conclusions: Neither study demonstrated that HCQ shortened viral shedding in mild to moderate COVID-19 subjects.

SUBMITTER: Chen CP 

PROVIDER: S-EPMC7710068 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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A multicenter, randomized, open-label, controlled trial to evaluate the efficacy and tolerability of hydroxychloroquine and a retrospective study in adult patients with mild to moderate coronavirus disease 2019 (COVID-19).

Chen Cheng-Pin CP   Lin Yi-Chun YC   Chen Tsung-Chia TC   Tseng Ting-Yu TY   Wong Hon-Lai HL   Kuo Cheng-Yu CY   Lin Wu-Pu WP   Huang Sz-Rung SR   Wang Wei-Yao WY   Liao Jia-Hung JH   Liao Chung-Shin CS   Hung Yuan-Pin YP   Lin Tse-Hung TH   Chang Tz-Yan TY   Hsiao Chin-Fu CF   Huang Yi-Wen YW   Chung Wei-Sheng WS   Cheng Chien-Yu CY   Cheng Shu-Hsing SH  

PloS one 20201202 12


<h4>Objective</h4>In this study, we evaluated the efficacy of hydroxychloroquine (HCQ) against coronavirus disease 2019 (COVID-19) via a randomized controlled trial (RCT) and a retrospective study.<h4>Methods</h4>Subjects admitted to 11 designated public hospitals in Taiwan between April 1 and May 31, 2020, with COVID-19 diagnosis confirmed by pharyngeal real-time RT-PCR for SARS-CoV-2, were randomized at a 2:1 ratio and stratified by mild or moderate illness. HCQ (400 mg twice for 1 d or HCQ 20  ...[more]

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