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RCT·clinical trial, infectious disease, pulmonology, critical care, internal medicine·PMC10590811

The KINETIC phase 2 randomized controlled trial of oral pamapimod-pioglitazone in non-critically ill COVID-19 inpatients

iScience · 7 authors, 3 centres

AI SUMMARY

FIDELITY 100%

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AGENT 01 · STRUCTURED SUMMARY

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TL;DR

The trial was stopped for futility due to a lower-than-expected incidence of the primary endpoint.

Full summary

333 CHARS

The trial was stopped for futility due to a lower-than-expected incidence of the primary endpoint. The study reported that KIN001 was safe and well-tolerated, with a similar incidence of adverse events between groups. Limitations included the trial being underpowered due to a low event rate and recruitment primarily in one country.

STUDY TYPE

RCT

SPECIALTY

clinical trial

SUMMARISED BY

AI pipeline

FIDELITY CHECK

100% · A

ORIGINAL PAPER

PMC10590811

The KINETIC phase 2 randomized controlled trial of oral pamapimod-pioglitazone in non-critically ill COVID-19 inpatients

iScience

READ THE FULL PAPER

ABSTRACT

Summary The combination of pamapimod and pioglitazone (KIN001) has a synergetic antiviral, anti-inflammatory, and antifibrotic activity, which may prevent evolution toward COVID-19-associated severe respiratory failure. In a randomized, placebo-controlled, double-blind, phase 2, multicenter trial, 128 non-critically ill hospitalized patients with confirmed COVID-19 were treated with KIN001 or a placebo for 28 days. The proportion of patients alive and free of oxygen or respiratory support at the end of the therapy was lower than anticipated but not different in the two groups (KIN001 n = 19, 29%, placebo n = 21, 33%). 85 participants had at least one adverse event, with no difference in the number and distribution of events between the two groups. The clinical trial was stopped for futility, mainly due to a lower-than-expected incidence of the primary endpoint. KIN001 was safe and well-tolerated but had no significant effect on clinical outcome.

CITATION EXPORT

Thierry Fumeaux, Claudia Berger, Alexander Bausch et al.. The KINETIC phase 2 randomized controlled trial of oral pamapimod-pioglitazone in non-critically ill COVID-19 inpatients. iScience. (2023). https://doi.org/10.1016/j.isci.2023.108038

AUTHORS

7 · 3 CENTRES

Thierry Fumeaux, Claudia Berger, Alexander Bausch, Matthew Wright, Urosh Vilimanovich, Ivan Soldatovic, Maria J.G.T. Vehreschild

1Kinarus Therapeutics AG, Technologiepark Basel, Hochbergerstrasse 60C, 4057 Basel, Switzerland
2Wemedoo AG, Sumpfstrasse 24, 6312 Steinhausen, Switzerland
3Department of Internal Medicine II, Infectious Diseases, University Hospital Frankfurt, Goethe University Frankfurt, 60596 Frankfurt Am Main, Germany