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

COVID-19 Pneumonia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04449588
• Other study ID #: STS-BDB001-04
• Status: Terminated
• Phase: Phase 2/Phase 3
• Start date: July 23, 2020
• Est. completion date: March 26, 2024

Study information

• Verified date: May 2024
• Source: Staidson (Beijing) Biopharmaceuticals Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 369
• Est. completion date: March 26, 2024
• Est. primary completion date: March 26, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• COVID-19 Pneumonia
• Pneumonia

Intervention

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.

Locations

Country	Name	City	State
Bangladesh	Asgar Ali Hospital	Dhaka
Bangladesh	Bangladesh Specialized Hospital	Dhaka
China	Southwest Hospital Chongqing	Chongqing	Chongqing
India	Noble Hospital Pvt Ltd	Nagpur
India	Government Medical College and Hospital	Pune
Indonesia	RSUD Cengkareng(Cengkareng General Hospital)	Jakarta	Jakrata
Indonesia	RSUD Pasar Minggu(Pasar Minggu General Hospital)	Jakarta
Indonesia	RSUP Persahabatan(Persahabatan General Hospital)	Jakarta
Spain	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

Sponsors (2)

Lead Sponsor	Collaborator
Staidson (Beijing) Biopharmaceuticals Co., Ltd	Beijing Defengrui Biotechnology Co. Ltd

Countries where clinical trial is conducted

Bangladesh,  China,  India,  Indonesia,  Spain, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to recovery of peripheral capillary oxygen saturation (SpO2) from baseline		Baseline to Day 28
Secondary	28-day all-cause mortality rate		Baseline to Day 28
Secondary	Percentage of patients who progress to critical severe		Baseline to Day 28
Secondary	Percentage of subjects achieving recovery in SpO2		Baseline to Day 28
Secondary	Mean change of PaO2/FiO2		Baseline to Day 28
Secondary	Mechanical ventilation time		Baseline to Day 28
Secondary	Time of oxygen therapy		Baseline to Day 28
Secondary	Change in inflammation indicators (CRP or IL-6 etc.) from baseline		Baseline to Day 28
Secondary	Improvement in body temperature		Baseline to Day 28
Secondary	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
Secondary	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
Secondary	Time to get categories 1 to 4 in the 8-points ordinal scale		Baseline to Day 28
Secondary	Time to attain an improvement of 1 point on the ordinal scale		Baseline to Day 28

External Links

•   Related Info
•   Related Info
•   Related Info
•   Related Info
•   Related Info