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

NCT04449588 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 369

Last updated 2024-05-22

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Beijing Defengrui Biotechnology Co. Ltd

    collaborator UNKNOWN

  • Staidson (Beijing) Biopharmaceuticals Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Qing Mao, Ph.D · Southwest Hospital of Chongqing

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-23
Primary Completion
2024-03-26
Completion
2024-03-26

Countries

  • Bangladesh
  • China
  • India
  • Indonesia
  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04449588 on ClinicalTrials.gov