Small retrospective study with 63 patients (32 treated with HCQ), showing no effectiveness, however the baseline state of each arm significantly differs.
This preprint was submitted to NEJM but has not been published several months later.
Standard of Care (SOC) for COVID-19 in the study country,
the USA, is
very poor with
very low average efficacy for approved treatments
1.
Only expensive, high-profit treatments were approved. Low-cost treatments were excluded, reducing the probability of treatment—especially early—due to access and cost barriers, and eliminating complementary and synergistic benefits seen with many low-cost treatments.
This study is excluded in the after exclusion results of meta
analysis:
excessive unadjusted differences between groups.
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risk of death, 147.0% higher, RR 2.47, p = 0.58, treatment 2 of 17 (11.8%), control 1 of 21 (4.8%).
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Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
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Barbosa et al., 12 Apr 2020, retrospective, USA, preprint, 5 authors.
Clinical Outcomes of Hydroxychloroquine in Hospitalized Patients with COVID-19: A Quasi-Randomized Comparative Study
New England, MD Joshua Barbosa, MD Daniel Kaitis, MD Ryan Freedman, MD Kim Le, MD Xihui Lin
Background: Off-label use of hydroxychloroquine in the SARS-CoV-2 positive population has become widespread with only empirical evidence on its efficacy. This study addresses the efficacy of hydroxychloroquine on serological and supportive care measures in a hospitalized population. Methods: Consecutive adult subjects admitted for viral pneumonia secondary to SARS-CoV-2 (by polymerase chain reaction) during the last two weeks of March, 2020 were included. Those that were started on hydroxychloroquine and supportive care were compared to supportive care alone. The primary end points were effect of hydroxychloroquine usage on the need to escalate respiratory support, change in lymphocyte count, and change in neutrophil-to-lymphocyte ratio. Results: A total of 63 patients were included with 32 in the hydroxychloroquine arm. Hydroxychloroquine administration was associated with a need for escalation of respiratory support level compared to those that did not receive hydroxychloroquine at 5 days (p=0.013). The same findings were observed in a baseline-matched subgroup analysis. Absolute lymphocyte change in the hydroxychloroquine group was no different than supportive care alone (p=0.413). Hydroxychloroquine use trended towards worsening neutrophil-to-lymphocyte ratio compared to supportive care alone (+9.59 vs +1.58, p=0.51) as well as a higher risk for intubation (p=0.051). Conclusion: Hydroxychloroquine administration to the hospitalized SARS-CoV-2 positive population was associated with an increased need for escalation of respiratory support. There were no benefits of hydroxychloroquine on mortality, lymphopenia, or neutrophil-tolymphocyte ratio improvement.
Confidential: Destroy when review is complete. Submitted to the New England Journal of Medicine
References
Chen, Hu, Zhang, Efficacy of hydroxychloroquine in patients with COVID-19: results of a randomized clinical trial, MedRxiv
Chen, Wu, Chen, Clinical characteristics of 113 deceased patients with coronavirus disease 2019: retrospective study, BMJ
Cucinotta, Vanelli, WHO declares COVID-19 a pandemic, Acta Biomed
Gautret, Lagier, Parola, Hydroxychloroquine and azithromycin as a treatment of COVID-19: Results of an open-label non-randomized clinical trial, Int J Antimicrob Agents
Liu, Liu, Xiang, Neutrophil-to-lymphocyte ratio predicts severe illness patients with 2019 novel coronavirus in the early stage, MedRxiv
