Effect of Cyproheptadine on Ventilatory Support-free Days in Critically Ill Patients with COVID-19: An Open-label, Randomized Clinical Trial
Miriane Melo Silveira Moretti, Márcio Manozzo Boniatti, Wagner Luis Nedel, Marcos Frata Rihl, Patricia Schwarz, Edino Parolo, Thiago Costa Lisboa
Indian Journal of Critical Care Medicine, doi:10.5005/jp-journals-10071-24482
Background: Serotonin is a mediator of pulmonary hypoxic vasoconstriction. Experimental studies have shown that serotonin-mediated pulmonary vasoconstriction can be inhibited by cyproheptadine. The aim of this study is to assess whether treatment with cyproheptadine compared to usual care increases ventilatory support-free days during the first 28 days in patients with coronavirus disease 2019 (COVID-19) requiring ventilatory support. Materials and methods: This randomized, single-center, open-label clinical trial included patients who were admitted to the intensive care unit (ICU) requiring ventilatory support due to COVID-19. Patients allocated to the intervention group received cyproheptadine for 10 days. The primary outcome was ventilator-free days during the first 28 days. Results: Nineteen patients were randomized to receive cyproheptadine and 21 to the control group. The number of ventilatory support-free days during the first 28 days was not different between the two groups (15.0; 95% CI, 0.0-24.0 days in the control group vs 7.0; 95% CI, 0.0-19.0 days in the intervention group; p = 0.284).
Conclusion: In patients with COVID-19 and in need of ventilatory support, the use of cyproheptadine plus usual care, compared with usual care alone, did not increase the number of ventilatory support-free days in 28 days.
AutHors' contributions Márcio MB, Wagner LN, Marcos FR, Patricia S, Edino P, Miriane MSM and Thiago CL have made substantial contributions to the conception and design of the study and to acquisition of data; Márcio MB and Thiago CL performed the analysis and the interpretation of data; all authors read and approved the final manuscript.
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