Hydroxychloroquine in the Treatment of COVID-19: A Multicenter Randomized Controlled Study
Abd-Elsalam et al.,
Hydroxychloroquine in the Treatment of COVID-19: A Multicenter Randomized Controlled Study,
American Journal of Tropical Medicine and Hygiene, doi:10.4269/ajtmh.20-0873
Small RCT in Egypt with 97/97 HCQ/control patients, showing 58% more recovery @28days for HCQ (53.6% HCQ, 34% control),
p=0.009 (0.06 in the paper refers to the 5 combined recovery/death/ICU values).
No significant difference in ventilation and mortality (<=6 examples in each case). Authors note the "sample size was not adequately powered for [the] survival endpoint".
Other studies have also shown treated patient cases resolved faster. Continuing analysis past 28 days would be useful. Group characteristics are given, with for example 36% vs. 26% smokers, but they do not identify which group is which. Group 1 and 2 have 97 patients but the total given is 175.
risk of death, 20.0% higher, RR 1.20, p = 1.00, treatment 6 of 97 (6.2%), control 5 of 97 (5.2%).
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risk of no recovery at day 28, 30.0% lower, RR 0.70, p = 0.009, treatment 45 of 97 (46.4%), control 64 of 97 (66.0%), NNT 5.1.
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Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
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Abd-Elsalam et al., 14 Aug 2020, Randomized Controlled Trial, Egypt, peer-reviewed, 10 authors.
Abstract: Am. J. Trop. Med. Hyg., 103(4), 2020, pp. 1635–1639
doi:10.4269/ajtmh.20-0873
Copyright © 2020 by The American Society of Tropical Medicine and Hygiene
Hydroxychloroquine in the Treatment of COVID-19: A Multicenter Randomized
Controlled Study
Sherief Abd-Elsalam,1* Eslam Saber Esmail,1 Mai Khalaf,1 Ehab Fawzy Abdo,2 Mohammed A. Medhat,2
Mohamed Samir Abd El Ghafar,3 Ossama Ashraf Ahmed,4 Shaimaa Soliman,5 Ghada N. Serangawy,6 and Mohamed Alboraie7
1
Department of Tropical Medicine and Infectious Diseases, Faculty of Medicine, Tanta University, Tanta, Egypt; 2Department of Gastroenterology
and Tropical Medicine, Faculty of Medicine, Assiut University, Assiut, Egypt; 3Department of Anesthesia, Surgical Intensive Care and Pain
Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt; 4Department of Internal Medicine, Ain-Shams University, Cairo, Egypt; 5Public
Health and Community Medicine, Menoufia University, Menoufia, Egypt; 6Department of Forensic Medicine and Toxicology, Faculty of Medicine,
Tanta University, Tanta, Egypt; 7Department of Internal Medicine, Al-Azhar University, Cairo, Egypt
Abstract. The COVID-19 pandemic is showing an exponential growth, mandating an urgent need to develop an effective
treatment. Indeed, to date, a well-established therapy is still lacking. We aimed to evaluate the safety and efficacy of
hydroxychloroquine (HCQ) added to standard care in patients with COVID-19. This was a multicenter, randomized controlled
trial conducted at three major university hospitals in Egypt. One hundred ninety-four patients with confirmed diagnosis of
COVID-19 were included in the study after signing informed consent. They were equally randomized into two arms: 97 patients
administrated HCQ plus standard care (HCQ group) and 97 patients administered only standard care as a control arm (control
group). The primary endpoints were recovery within 28 days, need for mechanical ventilation, or death. The two groups were
matched for age and gender. There was no significant difference between them regarding any of the baseline characteristics or
laboratory parameters. Four patients (4.1%) in the HCQ group and 5 (5.2%) patients in the control group needed mechanical
ventilation (P = 0.75). The overall mortality did not differ between the two groups, as six patients (6.2%) died in the HCQ group
and 5 (5.2%) died in the control group (P = 0.77). Univariate logistic regression analysis showed that HCQ treatment was not
significantly associated with decreased mortality in COVID-19 patients. So, adding HCQ to standard care did not add significant benefit, did not decrease the need for ventilation, and did not reduce mortality rates in COVID-19 patients.
Late treatment
is less effective
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