Adverse events were more common in those receiving the drug.
The anti-inflammatory drug hydroxychloroquine does not significantly reduce admission to intensive care or death in patients hospitalized with pneumonia due to COVID-19, finds a study from France published by The BMJ on May 14, 2020.
A randomized clinical trial from China also published on May 14, 2020, shows that hospitalized patients with mild to moderate persistent COVID-19 who received hydroxychloroquine did not clear the virus more quickly than those receiving standard care. Adverse events were higher in those who received hydroxychloroquine.
Taken together, the results do not support routine use of hydroxychloroquine for patients with COVID-19.
Hydroxychloroquine can reduce inflammation, pain, and swelling, and is widely used to treat rheumatic diseases. It is also used as an anti-malarial drug. Lab tests showed promising results, but accumulating trial and observational evidence has called into question whether there are any meaningful clinical benefits for patients with COVID-19.
Despite this, hydroxychloroquine has already been included in Chinese guidelines on how best to manage the disease, and the US Food and Drug Administration (FDA) issued an emergency use authorization to allow the drug to be provided to certain hospitalized patients. The FDA has since warned against use outside clinical trials or hospital settings due to the risk of heart rhythm problems.
In the first study, researchers in France assessed the effectiveness and safety of hydroxychloroquine compared with standard care in adults admitted to hospital with pneumonia due to COVID-19 who needed oxygen.
Of 181 patients, 84 received hydroxychloroquine within 48 hours of admission and 97 did not (control group).
They found no meaningful differences between the groups for transfer to intensive care, death within 7 days, or developing acute respiratory distress syndrome within 10 days.
The researchers say that caution is needed in the interpretation of their results, but that their findings do not support the use of hydroxychloroquine in patients hospitalized with COVID-19 pneumonia.
In the second study, researchers in China assessed the effectiveness and safety of hydroxychloroquine compared with standard care in 150 adults hospitalized with mainly mild or moderate COVID-19.
Patients were randomly split into two groups. Half received hydroxychloroquine in addition to standard care and the others received standard care only (control group).
By day 28, tests revealed similar rates of COVID-19 in the two groups but adverse events were more common in those who received hydroxychloroquine. Symptom alleviation and time to relief of symptoms also did not differ meaningfully between the two groups.
While further work is needed to confirm these results, the authors say that their findings do not support the use of hydroxychloroquine to treat patients with persistent mild to moderate COVID-19.
“Clinical efficacy of hydroxychloroquine in patients with covid-19 pneumonia who require oxygen: observational comparative study using routine care data” by Matthieu Mahévas, Viet-Thi Tran, Mathilde Roumier, Amélie Chabrol, Romain Paule, Constance Guillaud, Elena Fois, Raphael Lepeule, Tali-Anne Szwebel, François-Xavier Lescure, Frédéric Schlemmer, Marie Matignon, Mehdi Khellaf, Etienne Crickx, Benjamin Terrier, Caroline Morbieu, Paul Legendre, Julien Dang, Yoland Schoindre, Jean-Michel Pawlotsky, Marc Michel, Elodie Perrodeau, Nicolas Carlier, Nicolas Roche, Victoire de Lastours, Clément Ourghanlian, Solen Kerneis, Philippe Ménager, Luc Mouthon, Etienne Audureau, Philippe Ravaud, Bertrand Godeau, Sébastien Gallien and Nathalie Costedoat-Chalumeau, 14 May 2020, BMJ.
“Hydroxychloroquine in patients with mainly mild to moderate coronavirus disease 2019: open label, randomised controlled trial” by Wei Tang, Zhujun Cao, Mingfeng Han, Zhengyan Wang, Junwen Chen, Wenjin Sun, Yaojie Wu, Wei Xiao, Shengyong Liu, Erzhen Chen, Wei Chen, Xiongbiao Wang, Jiuyong Yang, Jun Lin, Qingxia Zhao, Youqin Yan, Zhibin Xie, Dan Li, Yaofeng Yang, Leshan Liu, Jieming Qu, Guang Ning, Guochao Shi and Qing Xie, 14 May 2020, BMJ.