PLoS ONE (Jan 2023)

A randomized controlled trial of teprenone in terms of preventing worsening of COVID-19 infection.

  • Eiki Ichihara,
  • Kou Hasegawa,
  • Kenichiro Kudo,
  • Yasushi Tanimoto,
  • Kazuhiro Nouso,
  • Naohiro Oda,
  • Sho Mitsumune,
  • Haruto Yamada,
  • Ichiro Takata,
  • Hideharu Hagiya,
  • Toshiharu Mitsuhashi,
  • Akihiko Taniguchi,
  • Shinichi Toyooka,
  • Kohei Tsukahara,
  • Toshiyuki Aokage,
  • Hirokazu Tsukahara,
  • Katsuyuki Kiura,
  • Yoshinobu Maeda

DOI
https://doi.org/10.1371/journal.pone.0287501
Journal volume & issue
Vol. 18, no. 10
p. e0287501

Abstract

Read online

BackgroundSome 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.MethodsThis 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 ResultsOne 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).ConclusionTeprenone afforded no clinical benefit.Trial registrationJapan Registry of Clinical Trials jRCTs061200002 (registered on 20/May/2020).