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Efficacy and Safety Study of BDB-001 in Severe COVID-19 With ALI/ARDS | Clinical Trials | Clareo Health

TERMINATEDPHASE2/PHASE3

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

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

NCT04449588•Staidson (Beijing) Biopharmaceuticals Co., Ltd

View on ClinicalTrials.gov

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).

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

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)
+3 more criteria

Locations (12)

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

Key Dates

Start Date

July 23, 2020

Primary Completion Date

March 26, 2024

Completion Date

March 26, 2024

Last Updated

May 22, 2024

Enrollment

369

ACTUAL participants

Conditions

COVID-19 Pneumonia

Interventions

BDB-001 Injection

DRUG

Conventional treatment

OTHER

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 22, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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