Efficacy and Safety Study of BDB-001 in Severe COVID-19 With ALI/ARDS
NCT ID: NCT04449588
Last Updated: 2024-05-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2/PHASE3
369 participants
INTERVENTIONAL
2020-07-23
2024-03-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Treatment group
BDB-001 Injection
BDB-001 Injection+Conventional treatment
Control group
Conventional treatment
Conventional treatment only. Local guidelines should be integrated to choose the best supportive care.
Interventions
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BDB-001 Injection
BDB-001 Injection+Conventional treatment
Conventional treatment
Conventional treatment only. Local guidelines should be integrated to choose the best supportive care.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
80 Years
ALL
No
Sponsors
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Beijing Defengrui Biotechnology Co. Ltd
UNKNOWN
Staidson (Beijing) Biopharmaceuticals Co., Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Qing Mao, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Southwest Hospital of Chongqing
Locations
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Asgar Ali Hospital
Dhaka, , Bangladesh
Bangladesh Specialized Hospital
Dhaka, , Bangladesh
Southwest Hospital Chongqing
Chongqing, Chongqing Municipality, China
Noble Hospital Pvt Ltd
Nagpur, , India
Government Medical College and Hospital
Pune, , India
RSUD Cengkareng(Cengkareng General Hospital)
Jakarta, Jakrata, Indonesia
RSUD Pasar Minggu(Pasar Minggu General Hospital)
Jakarta, , Indonesia
RSUP Persahabatan(Persahabatan General Hospital)
Jakarta, , Indonesia
Hospital Universitario 12 De Octubre
Madrid, , Spain
Hospital Universitario Clínico San Carlos
Madrid, , Spain
Hospital Universitario de la Princesa
Madrid, , Spain
Hospital Universitario Fundación Díaz
Madrid, , Spain
Countries
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References
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Guo RF, Ward PA. Role of C5a in inflammatory responses. Annu Rev Immunol. 2005;23:821-52. doi: 10.1146/annurev.immunol.23.021704.115835.
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.
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.
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.
Related Links
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Other Identifiers
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STS-BDB001-04
Identifier Type: -
Identifier Source: org_study_id
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