Efficacy and Safety Study of BDB-001 in Severe COVID-19 With ALI/ARDS
Study Details
Study Description
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. Patients will be randomized to two treatment arms (Arm A: Conventional treatment + BDB-001; Arm B: Conventional treatment alone).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2/Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Treatment group
|
Drug: BDB-001 Injection
BDB-001 Injection+Conventional treatment
|
| Experimental: Control group
|
Other: Conventional treatment
Conventional treatment only. Local guidelines should be integrated to choose the best supportive care.
|
Outcome Measures
Primary Outcome Measures
- Time to recovery of peripheral capillary oxygen saturation (SpO2) from baseline [Baseline to Day 28]
Secondary Outcome Measures
- 28-day all-cause mortality rate [Baseline to Day 28]
- Percentage of patients who progress to critical severe [Baseline to Day 28]
- Percentage of subjects achieving recovery in SpO2 [Baseline to Day 28]
- Mean change of PaO2/FiO2 [Baseline to Day 28]
- Mechanical ventilation time [Baseline to Day 28]
- Time of oxygen therapy [Baseline to Day 28]
- Change in inflammation indicators (CRP or IL-6 etc.) from baseline [Baseline to Day 28]
- Improvement in body temperature [Baseline to Day 28]
- Mean change from baseline in the clinical improvement based on ordinal scale recommended by the WHO R&D Blueprint during treatment period [Baseline to Day 28]
- Improvement at D3, 7, 11 & D14 based on ordinal scale recommended by the WHO R&D Blueprint during treatment period [Baseline，Day 3，Day 7，Day 11，Day 14]
- Time to get categories 1 to 4 in the 8-points ordinal scale [Baseline to Day 28]
- Time to attain an improvement of 1 point on the ordinal scale [Baseline to Day 28]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
18 years old ≤ age ≤ 80 years old, both men or women.
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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:
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Respiratory distress, RR ≥ 30 times/min
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Finger oxygen saturation (SpO2) ≤93% in resting state(room air)
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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 Criteria:
Subject who meets any of the following criteria will be excluded from the trial:
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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.
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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.
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Subjects on current treatment with a complement inhibitor such as eculizumab within 1 month before randomization.
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Subjects with hypersensitivity history to any ingredient contained in the drug.
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A subject has used the following drugs within 2 weeks prior to screening procedures:
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Calcineurin inhibitors (e.g., ciclosporin, tacrolimus, etc.)
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Proliferation inhibitors (e.g., everolimus, sirolimus, etc.)
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Anti-metabolic drugs (e.g., mycophenolate mofetil, mycophenolate, purine sulphate, etc.)
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Recombinant human granulocyte macrophage colony stimulating factor (rhGM-CSF)/recombinant human granulocyte colony stimulating factor (rhG-CSF)
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Pregnant or lactating woman.
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Subjects who have participated in other interventional clinical trials in the last 3 months or during this trial.
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Any other circumstances that the investigator considers inappropriate for the participation in this study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Asgar Ali Hospital | Dhaka | Bangladesh | ||
| 2 | Bangladesh Specialized Hospital | Dhaka | Bangladesh | ||
| 3 | Southwest Hospital Chongqing | Chongqing | Chongqing | China | 400038 |
| 4 | Noble Hospital Pvt Ltd | Nagpur | India | ||
| 5 | Government Medical College and Hospital | Pune | India | ||
| 6 | RSUD Cengkareng(Cengkareng General Hospital) | Jakarta | Jakrata | Indonesia | 11730 |
| 7 | RSUD Pasar Minggu(Pasar Minggu General Hospital) | Jakarta | Indonesia | 12550 | |
| 8 | RSUP Persahabatan(Persahabatan General Hospital) | Jakarta | Indonesia | 13230 | |
| 9 | Hospital Universitario 12 De Octubre | Madrid | Spain | ||
| 10 | Hospital Universitario Clínico San Carlos | Madrid | Spain | ||
| 11 | Hospital Universitario de la Princesa | Madrid | Spain | ||
| 12 | Hospital Universitario Fundación Díaz | Madrid | Spain |
Sponsors and Collaborators
- Staidson (Beijing) Biopharmaceuticals Co., Ltd
- Beijing Defengrui Biotechnology Co. Ltd
Investigators
- Principal Investigator: Qing Mao, Ph.D, Southwest Hospital of Chongqing
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- Guo RF, Ward PA. Role of C5a in inflammatory responses. Annu Rev Immunol. 2005;23:821-52. Review.
- Sun S, Zhao G, Liu C, Fan W, Zhou X, Zeng L, Guo Y, Kou Z, Yu H, Li J, Wang R, Li Y, Schneider C, Habel M, Riedemann NC, Du L, Jiang S, Guo R, Zhou Y. Treatment with anti-C5a antibody improves the outcome of H7N9 virus infection in African green monkeys. Clin Infect Dis. 2015 Feb 15;60(4):586-95. doi: 10.1093/cid/ciu887. Epub 2014 Nov 27.
- Sun S, Zhao G, Liu C, Wu X, Guo Y, Yu H, Song H, Du L, Jiang S, Guo R, Tomlinson S, Zhou Y. Inhibition of complement activation alleviates acute lung injury induced by highly pathogenic avian influenza H5N1 virus infection. Am J Respir Cell Mol Biol. 2013 Aug;49(2):221-30. doi: 10.1165/rcmb.2012-0428OC.
- Wang R, Xiao H, Guo R, Li Y, Shen B. The role of C5a in acute lung injury induced by highly pathogenic viral infections. Emerg Microbes Infect. 2015 May;4(5):e28. doi: 10.1038/emi.2015.28. Epub 2015 May 6. Review.
- Wood AJT, Vassallo A, Summers C, Chilvers ER, Conway-Morris A. C5a anaphylatoxin and its role in critical illness-induced organ dysfunction. Eur J Clin Invest. 2018 Dec;48(12):e13028. doi: 10.1111/eci.13028. Epub 2018 Oct 15. Review.
- STS-BDB001-04