NCT04449588

Efficacy and Safety Study of BDB-001 in Severe COVID-19 With ALI/ARDS

A Multi-center, Open-label, Randomized Parallel Controlled Evaluation on the Efficacy and Safety of BDB-001 Injection in the Treatment of Progressive Severe COVID-19 in Phase II/III

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 369 (actual)
• Sponsor: Staidson (Beijing) Biopharmaceuticals Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This multi-center, open, randomized study will evaluate the efficacy and safety of BDB-001 injection in severe COVID-19 with severe pneumonia, or acute lung injury/acute respiratory distress syndrome. Patients will be randomized to two treatment arms (Arm A: Conventional treatment + BDB-001; Arm B: Conventional treatment alone).

Conditions

• COVID-19 Pneumonia

Interventions

Type	Name	Description
DRUG	BDB-001 Injection	BDB-001 Injection+Conventional treatment
OTHER	Conventional treatment	Conventional treatment only. Local guidelines should be integrated to choose the best supportive care.

Timeline

• Start date: 2020-07-23
• Primary completion: 2024-03-26
• Completion: 2024-03-26
• First posted: 2020-06-29
• Last updated: 2024-05-22

Locations

12 sites across 5 countries: Bangladesh, China, India, Indonesia, Spain