Hydroxychloroquine in the Treatment of COVID-19: A Multicenter Randomized Controlled Study
Authors: Ghada N Serangawy
Mohamed Alboraie
Ossama Ashraf Ahmed
Shaimaa Soliman
Ehab Fawzy Abdo
Sherief Abd-Elsalam
Mai Khalaf
Mohamed Samir Abd El Ghafar
Mohammed A Medhat
Eslam Saber Esmail
Journal: American Journal of Tropical Medicine and Hygiene (2020)
Discipline: CLINICAL MEDICINE
Keywords: COVID-19 pandemic; hydroxychloroquine; treatment efficacy; randomized controlled trial; mechanical ventilation
Affiliations: Department of Tropical Medicine and Infectious Diseases, Faculty of Medicine, Tanta University, Tanta, Egypt;, Department of Gastroenterology and Tropical Medicine, Faculty of Medicine, Assiut University, Assiut, Egypt;, Department of Anesthesia, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt;, Department of Internal Medicine, Ain-Shams University, Cairo, Egypt;, Public Health and Community Medicine, Menoufia University, Menoufia, Egypt;, Department of Forensic Medicine and Toxicology, Faculty of Medicine, Tanta University, Tanta, Egypt;, Department of Internal Medicine, Al-Azhar University, Cairo, Egypt

Abstract:  RETRACTED ARTICLE: The COVID-19 pandemic is showing an exponential growth, mandating an urgent need to develop an effective treatment.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. 

Retracted: No

PubPeer comments:
 There was a statistically significant benefit for the  recovery endpoint: 52 97 vs 33 97, p=0.006 . According to the  methods section, it appears to be the principal endpoint of the study. It is curious that the authors concluded that there was no effect and that they presented this data as evidence against the treatment. For the other endpoints (e.g. mortality, need for ICU) there were very few events so the study is underpowered and inconclusive. , 
 Retraction, 2 September 2022: https: www.ajtmh.org view journals tpmd aop article-10.4269-ajtmh.1073ret article-10.4269-ajtmh.1073ret.xml  * Abd-Elsalam S, Esmail ES, Khalaf M, Abdo EF, Medhat MA, Abd El Ghafar MS, Ahmed OA, Soliman S, Serangawy GN, Albor-aie M, 2020. Hydroxychloroquine in the Treatment of COVID-19: A Multicenter Randomized Controlled Study.Am J Trop MedHyg 103(4):1635u20131639. doi: 10.4269 ajtmh.20-0873. PMID: 32828135; PMCID: PMC7543820. * Abd-Elsalam S, Salama M, Soliman S, Naguib AM, Ibrahim IS, Torky M, El Ghafar MSA, Abdul-Baki EAM, Elhendawy M,2021. Remdesivir Efficacy in COVID-19 Treatment: A Randomized Controlled Trial.Am J Trop Med Hyg 106(3):886u2013890.doi: 10.4269 ajtmh.21-0606. PMID: 34649223; PMCID: PMC8922517.  The above articles, published inThe American Journal of Tropical Medicine and Hygiene, have been retracted by the Journal. The decision is the result of an investigation based on concerns raised by a third party. Specific concerns are as follows. First, as acknowledged by the authors, data overlap and or copying has occurred between the two manuscripts. Second, the authors have not provided a reasonable explanation for this major problem. Third, adequate data error-checking or validation has not been provided by the authors to ensure that the remaining results presented in the papers accurately represent the sourced data. Given these facts, the Journal has lost confidence in the totality of data described in the two papers. Because of this, and because of insufficient answers to repeated inquiries, we have made the decision to retract both articles.Published online September 2, 2022.1Am. J. Trop. Med. Hyg., 00(00), 2022, p. 1doi:10.4269 ajtmh.1073ret  ,