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 et al., PLoS ONE, doi:10.1371/journal.pone.0242763, NCT04384380

Jul 2020

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2 very small studies with hospitalized patients in Taiwan.

RCT with 21 treatment and 12 SOC patients. No mortality, or serious adverse effects. Median time to negative RNA 5 days versus 10 days SOC, p=0.4. Risk of PCR+ at day 14, RR 0.76, p = 0.71.

This paper also reports on a small retrospective study with 12 of 28 HCQ patients and 5 of 9 in the control group being PCR- at day 14, RR 1.29, p = 0.7.

Although the viral clearance result is not statistically significant, it is consistent with the significant 20% improved viral clearance [10‑28%] from meta analysis of the 44 viral clearance results to date.

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risk of no viral clearance, 24.0% lower, RR 0.76, p = 0.71, treatment 4 of 21 (19.0%), control 3 of 12 (25.0%), NNT 17, day 14.

median time to PCR-, 50.0% lower, relative time 0.50, p = 0.40, treatment 21, control 12.

Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates

Chen et al., 10 Jul 2020, Randomized Controlled Trial, Taiwan, peer-reviewed, 19 authors, study period 1 April, 2020 - 31 May, 2020, trial NCT04384380 (history).

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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)

Cheng-Pin Chen, Yi-Chun Lin, Tsung-Chia Chen, Ting-Yu Tseng, Hon-Lai Wong, Cheng-Yu Kuo, Wu-Pu Lin, Sz-Rung Huang, Wei-Yao Wang, Jia-Hung Liao, Chung-Shin Liao, Yuan-Pin Hung, Tse-Hung Lin, Tz-Yan Chang, Chin-Fu Hsiao, Yi-Wen Huang, Wei-Sheng Chung, Chien-Yu Cheng, Shu-Hsing Cheng

PLOS ONE, doi:10.1371/journal.pone.0242763

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

Author Contributions Conceptualization: Cheng-Pin Chen, Yi-Chun Lin, Chien-Yu Cheng, Shu-Hsing Cheng. Data curation: Yi-Chun Lin, Chin-Fu Hsiao, Shu-Hsing Cheng. Formal analysis: Cheng-Pin Chen, Yi-Chun Lin, Chin-Fu Hsiao, Chien-Yu Cheng, Shu-Hsing Cheng. Funding acquisition: Shu-Hsing Cheng. Investigation: Cheng-Pin Chen, Tsung-Chia Chen, Ting-Yu Tseng, Hon-Lai Wong, Cheng-Yu Kuo, Wu-Pu Lin, Sz-Rung Huang, Wei-Yao Wang, Jia-Hung Liao, Chung-Shin Liao, Yuan-Pin Hung, Tse-Hung Lin, Tz-Yan Chang, Yi-Wen Huang, Wei-Sheng Chung, Chien-Yu Cheng. Methodology: Chin-Fu Hsiao, Chien-Yu Cheng. Supervision: Yi-Wen Huang, Wei-Sheng Chung. Writing -original draft: Cheng-Pin Chen, Yi-Chun Lin. Writing -review & editing: Chien-Yu Cheng, Shu-Hsing Cheng.

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Late treatment
is less effective

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