NCT04463602

Desidustat in the Management of COVID-19 Patients

A Phase 2b, Multicenter, Open-label, Randomized, Comparator-Controlled, Study to Evaluate the Efficacy and Safety of Desidustat Tablet for the Management of COVID-19 Patients

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Zydus Lifesciences Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a Phase 2b, Multicenter, Open-label, Randomized, Comparator- Controlled Study to Evaluate the Efficacy and Safety of Desidustat Tablet for the Management of mild, moderate and severe COVID-19 patients. 100 mg of Desidustat will be administered for a period of 14 days along with recommended standard care during the trial.

Detailed description

This is a phase 2b, multicenter, open-label, randomized, comparator-controlled clinical trial to evaluate the efficacy and safety of Desidustat for the management of COVID-19 patients. First 12 mild to moderate subjects (Test arm: Desidustat + Standard of care arm, 06 subjects and Reference arm: Standard of care, 06 subjects) will be enrolled in the study and after evaluation of safety of these 12 subjects by Data Monitoring Committee other 12 severe subjects (Test arm: Desidustat + Standard of care arm, 06 subjects and Reference arm: Standard of care arm, 06 subjects) will be enrolled in the study.

Conditions

• COVID-19

Interventions

Type	Name	Description
DRUG	Desidustat	100 mg once daily
OTHER	Standard of Care	Standard of care as per local authority

Timeline

• Start date: 2020-07-25
• Primary completion: 2021-01-25
• Completion: 2021-03-31
• First posted: 2020-07-09
• Last updated: 2021-04-23

Locations

1 site across 1 country: Mexico