Clinical trial
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
Name
STS-BDB001-04
Description
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).
Trial arms
Trial start
2020-07-23
Estimated PCD
2024-05-01
Trial end
2024-05-01
Status
Active (not recruiting)
Phase
Early phase I
Treatment
BDB-001 Injection
BDB-001 Injection+Conventional treatment
Arms:
Treatment group
Conventional treatment
Conventional treatment only. Local guidelines should be integrated to choose the best supportive care.
Arms:
Control group
Size
368
Primary endpoint
Time to recovery of peripheral capillary oxygen saturation (SpO2) from baseline
Baseline to Day 28
Eligibility criteria
Inclusion Criteria:
1. 18 years old ≤ age ≤ 80 years old, both men or women.
2. 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:
1. Respiratory distress, RR ≥ 30 times/min
2. Finger oxygen saturation (SpO2) ≤93% in resting state(room air)
3. Arterial partial pressure of oxygen to fraction of inspired oxygen (PaO2/FiO2) ≤ 300 mmHg (1 mmHg = 0.133kpa) in supine position
4. Pulmonary imaging shows lesion progression \> 50% within 24-48 hours.
Symptoms,signs or chest imaging indicates ALI/ARDS;
3. Requiring a mask oxygen therapy,high-flow nasal cannula oxygen therapy(HFNC).
4. The informed consent form signed.
Exclusion Criteria:
Subject who meets any of the following criteria will be excluded from the trial:
1. 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.
2. 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.
3. Subjects on current treatment with a complement inhibitor such as eculizumab within 1 month before randomization.
4. Subjects with hypersensitivity history to any ingredient contained in the drug.
5. 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)
6. Pregnant or lactating woman.
7. Subjects who have participated in other interventional clinical trials in the last 3 months or during this trial.
8. Any other circumstances that the investigator considers inappropriate for the participation in this study.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 368, 'type': 'ESTIMATED'}}
Updated at
2023-12-29
1 organization
1 product
1 indication
Organization
Staidson BiopharmaceuticalsProduct
BDB-001Indication
COVID-19 Pneumonia