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PLoS One . 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)

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  • PLoS One . 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)


    PLoS One


    . 2020 Dec 2;15(12):e0242763.
    doi: 10.1371/journal.pone.0242763. eCollection 2020.
    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)


    Cheng-Pin Chen 1 2 , Yi-Chun Lin 1 3 , Tsung-Chia Chen 4 , Ting-Yu Tseng 4 , Hon-Lai Wong 5 , Cheng-Yu Kuo 6 , Wu-Pu Lin 7 , Sz-Rung Huang 8 , Wei-Yao Wang 9 , Jia-**** Liao 10 , Chung-Shin Liao 11 , Yuan-Pin **** 12 , Tse-**** Lin 13 , Tz-Yan Chang 13 , Chin-Fu Hsiao 14 , Yi-Wen Huang 13 15 , Wei-Sheng Chung 4 16 17 , Chien-Yu Cheng 1 18 , Shu-Hsing Cheng 1 19 , Taiwan HCQ Study Group



    Affiliations

    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.


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