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drugset / Trial / NCT04776044

Clinical Trial to Evaluate the Safety and Efficacy of ATR-002 in Adult Hospitalized Patients With COVID-19

NCT04776044 ↗

Phase 2 Terminated 133 enrolled Atriva Therapeutics GmbH

RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of the study is to assess the safety and efficacy of ATR-002 (in addition to standard-of-care) for the treatment of COVID-19

Timeline

Start: 2021-04-12
Primary completion: 2022-06-06
Completion: 2022-08-09

Outcome

Missed primary endpoint

Stopped: “general circumstances around COVID-19 and current availability of hospitalized patients”

paper The primary outcome was not significantly different between the two groups PMID 38106555 ↗

Publications

Rohde G, Stenglein S, Prozesky H, Manudhane G, Sandulescu O, Bauer M, Overend T, Koch W, Neuschwander D, Planz O, Torres A, Witzenrath M. Efficacy and safety of zapnometinib in hospitalised adult patients with COVID-19 (RESPIRE): a randomised, double-blind, placebo-controlled, multicentre, proof-of-concept, phase 2 trial. EClinicalMedicine. 2023 Oct 4;65:102237. doi: 10.1016/j.eclinm.2023.102237. eCollection 2023 Nov.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	ZAPNOMETINIB	Small molecule	600 mg	Oral

Indications