Hydroxychloroquine in patients with mainly mild to moderate coronavirus disease 2019: open label, randomised controlled trial
Tang et al.
, Hydroxychloroquine in patients with mainly mild to moderate coronavirus disease 2019: open label, randomised..
, BMJ 2020, 369, doi:10.1136/bmj.m1849
150 patients very late stage RCT showing no significant difference. Treatment very late, average 16.6 days after symptom onset.
Data favorable to HCQ was deleted in the second version, see analysis [mediterranee-infection.com]
. "[HCQ] accelerate[s] the alleviation of clinical symptoms"; "More rapid alleviation of clinical symptoms with SOC plus HCQ than with SOC alone was observed during the second week since randomization"; "The efficacy of HCQ on the alleviation of symptoms, HR 8.83 [1.09-71.3], was more evident when the confounding effects of other anti-viral agents were removed"
Although the viral clearance result is not statistically significant, it is consistent with the significant 20% improved viral clearance [10‑29%]
from meta analysis of the 42 viral clearance results to date
risk of no virological cure at day 21, 21.4% lower, RR 0.79, p = 0.51, treatment 11 of 75 (14.7%), control 14 of 75 (18.7%), NNT 25.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Tang et al., 14 Apr 2020, Randomized Controlled Trial, China, peer-reviewed, 24 authors, average treatment delay 16.6 days.
Wei Tang,1,2 Zhujun Cao,3 Mingfeng Han,4 Zhengyan Wang,5 Junwen Chen,6 Wenjin Sun,7
Yaojie Wu,8 Wei Xiao,9 Shengyong Liu,10 Erzhen Chen,11 Wei Chen,1,2 Xiongbiao Wang,12
Jiuyong Yang,13 Jun Lin,14 Qingxia Zhao,15 Youqin Yan,16 Zhibin Xie,17 Dan Li,18 Yaofeng Yang,19
Leshan Liu,20 Jieming Qu,1,2 Guang Ning,21 Guochao Shi,1,2 Qing Xie3
For numbered affiliations see
end of the article
Correspondence to: Q Xie
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Cite this as: BMJ 2020;369:m1849
Accepted: 6 May 2020
To assess the efficacy and safety of
hydroxychloroquine plus standard of care compared
with standard of care alone in adults with coronavirus
disease 2019 (covid-19).
Multicentre, open label, randomised controlled trial.
16 government designated covid-19 treatment centres
in China, 11 to 29 February 2020.
150 patients admitted to hospital with laboratory
confirmed covid-19 were included in the intention
to treat analysis (75 patients assigned to
hydroxychloroquine plus standard of care, 75 to
standard of care alone).
Hydroxychloroquine administrated at a loading
dose of 1200 mg daily for three days followed by a
maintenance dose of 800 mg daily (total treatment
duration: two or three weeks for patients with mild to
moderate or severe disease, respectively).
MAIN OUTCOME MEASURE
Negative conversion of severe acute respiratory
syndrome coronavirus 2 by 28 days, analysed
according to the intention to treat principle. Adverse
events were analysed in the safety population
in which hydroxychloroquine recipients were
WHAT IS ALREADY KNOWN ON THIS TOPIC
The pandemic of coronavirus disease 2019 (covid-19) imposes a substantial
burden on individuals, communities, healthcare facilities, markets, and
No specific treatment has been approved for covid-19, and no vaccine exists to
prevent infection with SARS-CoV-2
During the urgent pandemic, media headlines encourage the use of drugs
without solid evidence but ignore the side effects of these drugs
WHAT THIS STUDY ADDS
In this randomised clinical trial of patients with mainly persistent mild to
moderate covid-19, exposure to hydroxychloroquine led to a similar probability
of virus elimination to the current standard of care
Adverse events, mostly gastrointestinal, were significantly higher in patients who
Overall, the results do not support the use of hydroxychloroquine in patients
with persistent mild to moderate covid-19
the bmj | BMJ 2020;369:m1849 | doi: 10.1136/bmj.m1849
participants who received at least one dose of
hydroxychloroquine and hydroxychloroquine nonrecipients were those managed with standard of care
Of 150 patients, 148 had mild to moderate disease
and two had severe disease. The mean duration
from symptom onset to randomisation was 16.6
(SD 10.5; range 3-41) days. A total of 109 (73%)
patients (56 standard of care; 53 standard of care
plus hydroxychloroquine) had negative conversion
well before 28 days, and the remaining 41 (27%)
patients (19 standard of care; 22 standard of care
plus hydroxychloroquine) were censored as they did
not reach negative conversion of virus. The probability
of negative conversion by 28 days in the standard
of care plus hydroxychloroquine group was 85.4%
(95% confidence interval 73.8% to 93.8%),..
is less effective
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