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- Title
A randomized controlled trial of teprenone in terms of preventing worsening of COVID-19 infection.
- Authors
Ichihara, Eiki; Hasegawa, Kou; Kudo, Kenichiro; Tanimoto, Yasushi; Nouso, Kazuhiro; Oda, Naohiro; Mitsumune, Sho; Yamada, Haruto; Takata, Ichiro; Hagiya, Hideharu; Mitsuhashi, Toshiharu; Taniguchi, Akihiko; Toyooka, Shinichi; Tsukahara, Kohei; Aokage, Toshiyuki; Tsukahara, Hirokazu; Kiura, Katsuyuki; Maeda, Yoshinobu
- Abstract
Background: Some COVID-19 patients develop life-threatening disease accompanied by severe pneumonitis. Teprenone induces expression of heat-shock proteins (HSPs) that protect against interstitial pneumonia in preclinical models. We explored whether teprenone prevented worsening of COVID-19 infections. Methods: This open-label, randomized, pilot phase 2 clinical trial was conducted at five institutions in Japan. We randomized patients hospitalized for COVID-19 with fever to teprenone or no-teprenone groups in a 1:1 ratio. We stratified patients by sex, age < and ≥ 70 years and the existence (or not) of complications (hypertension, diabetes, ischemic heart disease, chronic pulmonary disease and active cancer). No limitation was imposed on other COVID-19 treatments. The primary endpoint was the intubation rate. Results: One hundred patients were included, 51 in the teprenone and 49 in the no- teprenone groups. The intubation rate did not differ significantly between the two groups: 9.8% (5/51) vs. 2.0% (1/49) (sub-hazard ratio [SHR] 4.99, 95% confidence interval [CI]: 0.59–42.1; p = 0.140). The rates of intra-hospital mortality and intensive care unit (ICU) admission did not differ significantly between the two groups: intra-hospital mortality 3.9% (2/51) vs. 4.1% (2/49) (hazard ratio [HR] 0.78, 95%CI: 0.11–5.62; p = 0.809); ICU admission 11.8% (6/51) vs. 6.1% (3/49) (SHR 1.99, 95%CI: 0.51–7.80; p = 0.325). Conclusion: Teprenone afforded no clinical benefit. Trial registration: Japan Registry of Clinical Trials jRCTs061200002 (registered on 20/May/2020).
- Subjects
JAPAN; COVID-19; RANDOMIZED controlled trials; MYOCARDIAL ischemia; PULMONARY fibrosis; COVID-19 treatment
- Publication
PLoS ONE, 2023, Vol 18, Issue 10, p1
- ISSN
1932-6203
- Publication type
Article
- DOI
10.1371/journal.pone.0287501