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

NCT04449588 | Terminated Phase 2 DMC

• 1 other identifier: STS-BDB001-04
• Study Type: interventional
• Target: 369
• Locations: 5 countries
• Sites: 12

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).

Conditions

COVID-19 Pneumonia

Keywords

COVID-19; Severe Pneumonia; ALI/ARDS

Outcome Measures

Primary Outcomes (1)

• Time to recovery of peripheral capillary oxygen saturation (SpO2) from baseline

  Baseline to Day 28

Secondary Outcomes (12)

• 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

Study Arms (2)

Treatment group

EXPERIMENTAL

Drug: BDB-001 Injection

Control group

EXPERIMENTAL

Other: Conventional treatment

Interventions

BDB-001 Injection DRUG

BDB-001 Injection+Conventional treatment

Treatment group

Conventional treatment OTHER

Conventional treatment only. Local guidelines should be integrated to choose the best supportive care.

Control group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Staidson (Beijing) Biopharmaceuticals Co., Ltd: lead
• Beijing Defengrui Biotechnology Co. Ltd: collaborator

Study Sites (12)

Asgar Ali Hospital

Dhaka, Bangladesh

Location

Bangladesh Specialized Hospital

Dhaka, Bangladesh

Location

Southwest Hospital Chongqing

Chongqing, Chongqing Municipality, 400038, China

Location

Noble Hospital Pvt Ltd

Nagpur, India

Location

Government Medical College and Hospital

Pune, India

Location

RSUD Cengkareng(Cengkareng General Hospital)

Jakarta, Jakrata, 11730, Indonesia

Location

RSUD Pasar Minggu(Pasar Minggu General Hospital)

Jakarta, 12550, Indonesia

Location

RSUP Persahabatan(Persahabatan General Hospital)

Jakarta, 13230, Indonesia

Location

Hospital Universitario 12 De Octubre

Madrid, Spain

Location

Hospital Universitario Clínico San Carlos

Madrid, Spain

Location

Hospital Universitario de la Princesa

Madrid, Spain

Location

Hospital Universitario Fundación Díaz

Madrid, Spain

Location

Related 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.

  PMID: 15771587 BACKGROUND

• 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.

  PMID: 30229880 BACKGROUND

• 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.

  PMID: 26060601 BACKGROUND

• 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.

  PMID: 25433014 BACKGROUND

• 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.

  PMID: 23526211 BACKGROUND

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MeSH Terms

Conditions

COVID-19; Pneumonia

Interventions

BDB001

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Qing Mao, Ph.D

  Southwest Hospital of Chongqing

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2020
• First Posted: June 29, 2020
• Study Start: July 23, 2020
• Primary Completion: March 26, 2024
• Study Completion: March 26, 2024
• Last Updated: May 22, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

BA (2); IN (2); ES (4); CN (1); ID (3)