A Randomized Controlled Trial of Teprenone in Terms of Preventing Worsening of COVID-19 Infection

Overview

Journal PLoS One

Specialties General Medicine
Science

Date 2023 Oct 26

PMID 37883347

Authors

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

Affiliations

Soon will be listed here.

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).

Citing Articles

Increased Oxidative Stress and Decreased Citrulline in Blood Associated with Severe Novel Coronavirus Pneumonia in Adult Patients.

Tsuge M, Ichihara E, Hasegawa K, Kudo K, Tanimoto Y, Nouso K Int J Mol Sci. 2024; 25(15).

PMID: 39125944 PMC: 11313210. DOI: 10.3390/ijms25158370.

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