Status:
TERMINATED
Efficacy and Safety Study of BDB-001 in Severe COVID-19 With ALI/ARDS
Lead Sponsor:
Staidson (Beijing) Biopharmaceuticals Co., Ltd
Collaborating Sponsors:
Beijing Defengrui Biotechnology Co. Ltd
Conditions:
COVID-19 Pneumonia
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
PHASE3
Brief 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....
Eligibility Criteria
Inclusion
- 18 years old ≤ age ≤ 80 years old, both men or women.
- Confirmed SARS-CoV-2 infection, and meet at least one of the following criteria:
- Confirmed severe COVID-19 in no more than 5 days who meets any of the following criteria:
- Respiratory distress, RR ≥ 30 times/min
- Finger oxygen saturation (SpO2) ≤93% in resting state(room air)
- Arterial partial pressure of oxygen to fraction of inspired oxygen (PaO2/FiO2) ≤ 300 mmHg (1 mmHg = 0.133kpa) in supine position
- Pulmonary imaging shows lesion progression \> 50% within 24-48 hours.
- Symptoms,signs or chest imaging indicates ALI/ARDS;
- Requiring a mask oxygen therapy,high-flow nasal cannula oxygen therapy(HFNC).
- The informed consent form signed.
Exclusion
- Subject who meets any of the following criteria will be excluded from the trial:
- Subjects already progressed into critically severe COVID-19 Critical severe standards refer to FDA guidelines,as shown in Appendix 4 or sepsis and sepsis shock.
- Concomitant with the following situation:severe lung disease such as chronic obstructive pulmonary disease (moderate to severe type), lung cancers, active tuberculosis; severe cardiovascular and cerebrovascular disease: unstable angina pectoris, myocardial infarction, postcardiac surgery, cardiac function ≥ grade 3 (NYHA Classification), or had undergone heart surgery within 6 months before randomization; severe liver diseases (e.g. Child-Pugh score ≥ grade C); severe kidney diseases, such as renal insufficiency (GFR ≤ 15 mL/min/1.73m\^2); immune deficiencies or immune-related diseases : including organ or bone marrow transplantation, some autoimmune diseases, IgG4-related diseases, allergic alveolitis, vasculitis; malignancies.
- Subjects on current treatment with a complement inhibitor such as eculizumab within 1 month before randomization.
- Subjects with hypersensitivity history to any ingredient contained in the drug.
- A subject has used the following drugs within 2 weeks prior to screening procedures:
- Calcineurin inhibitors (e.g., ciclosporin, tacrolimus, etc.)
- Proliferation inhibitors (e.g., everolimus, sirolimus, etc.)
- Anti-metabolic drugs (e.g., mycophenolate mofetil, mycophenolate, purine sulphate, etc.)
- Recombinant human granulocyte macrophage colony stimulating factor (rhGM-CSF)/recombinant human granulocyte colony stimulating factor (rhG-CSF)
- Pregnant or lactating woman.
- Subjects who have participated in other interventional clinical trials in the last 3 months or during this trial.
- Any other circumstances that the investigator considers inappropriate for the participation in this study.
Key Trial Info
Start Date :
July 23 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 26 2024
Estimated Enrollment :
369 Patients enrolled
Trial Details
Trial ID
NCT04449588
Start Date
July 23 2020
End Date
March 26 2024
Last Update
May 22 2024
Active Locations (12)
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1
Asgar Ali Hospital
Dhaka, Bangladesh
2
Bangladesh Specialized Hospital
Dhaka, Bangladesh
3
Southwest Hospital Chongqing
Chongqing, Chongqing Municipality, China, 400038
4
Noble Hospital Pvt Ltd
Nagpur, India