NCT04776044

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

RESPIRE - A Randomized, Double-Blind, Placebo-Controlled, Multi-Centre Clinical Trial to Evaluate the Safety and Efficacy of ATR-002 in Adult Hospitalized Patients With COVID-19

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 133 (actual)
• Sponsor: Atriva Therapeutics GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

After being informed about the study and potential risks, all patients giving written informed consent will be undergoing a 1-day screening to determine eligibility for study entry. At day 1, patients who meet the eligibility requirements will be randomized in a double-blind manner (participant and investigator) in a 1:1 ratio to ATR-002 (900mg day 1, 600mg days 2 - 6) or placebo (once daily)

Conditions

• COVID-19

Interventions

Type	Name	Description
DRUG	ATR-002	150mg tablets for oral intake
DRUG	Placebo	matching tablets for oral intake

Timeline

• Start date: 2021-04-12
• Primary completion: 2022-06-06
• Completion: 2022-08-09
• First posted: 2021-03-01
• Last updated: 2022-09-22

Locations

40 sites across 7 countries: Germany, India, Netherlands, Poland, Romania, South Africa, Spain