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Randomized Controlled Trial Multicenter Study
Early Use of Corticosteroid May Prolong SARS-CoV-2 Shedding in Non-Intensive Care Unit Patients with COVID-19 Pneumonia: A Multicenter, Single-Blind, Randomized Control Trial.
- Xiao Tang, Ying-Mei Feng, Ji-Xiang Ni, Jia-Ying Zhang, Li-Min Liu, Ke Hu, Xiu-Zhi Wu, Ji-Xian Zhang, Jun-Wen Chen, Jian-Chu Zhang, Jian Su, Yu-Lei Li, Yang Zhao, Jiao Xie, Zhou Ding, Xin-Liang He, Wen Wang, Rong-Hua Jin, Huan-Zhong Shi, and Bing Sun.
- Department of Respiratory and Critical Care Medicine, Beijing Chao-Yang Hospital, Capital Medical University, Beijing Institute of Respiratory Medicine, Beijing, China, 121930193@qq.com.
- Respiration. 2021 Jan 1; 100 (2): 116-126.
BackgroundThere is still no clinical evidence available to support or to oppose corticosteroid treatment for coronavirus disease 2019 (COVID-19) pneumonia.ObjectiveTo investigate the efficacy and safety of corticosteroid given to the hospitalized patients with COVID-19 pneumonia.MethodsThis was a prospective, multicenter, single-blind, randomized control trial. Adult patients with COVID-19 pneumonia who were admitted to the general ward were randomly assigned to either receive methylprednisolone or not for 7 days. The primary end point was the incidence of clinical deterioration 14 days after randomization.ResultsWe terminated this trial early because the number of patients with COVID-19 pneumonia in all the centers decreased in late March. Finally, a total of 86 COVID-19 patients underwent randomization. There was no difference of the incidence of clinical deterioration between the methylprednisolone group and control group (4.8 vs. 4.8%, p = 1.000). The duration of throat viral RNA detectability in the methylprednisolone group was 11 days (interquartile range, 6-16 days), which was significantly longer than that in the control group (8 days [2-12 days], p = 0.030). There were no significant differences between the 2 groups in other secondary outcomes. Mass cytometry discovered CD3+ T cells, CD8+ T cells, and NK cells in the methylprednisolone group which were significantly lower than those in the control group after randomization (p < 0.05).ConclusionsFrom this prematurely closed trial, we found that the short-term early use of corticosteroid could suppress the immune cells, which may prolong severe acute respiratory syndrome coronavirus 2 shedding in patients with COVID-19 pneumonia.Trial RegistrationClinicalTrials.gov, NCT04273321.© 2021 S. Karger AG, Basel.
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