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

Phase 2

Terminated

• Conditions: COVID-19 Pneumonia
• Interventions: Drug: BDB-001 Injection; Other: Conventional treatment

• Registration Number: NCT04449588
• Lead Sponsor: Staidson (Beijing) Biopharmaceuticals Co., Ltd

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-06-26
• Study First Submitted QC: 2020-06-26
• Study First Posted: 2020-06-29
• Study Start: 2020-07-23
• Primary Completion: 2024-03-26
• Study Completion: 2024-03-26
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-20
• Last Update Posted: 2024-05-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 369

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment group	BDB-001 Injection	-
Control group	Conventional treatment	-

Primary Outcome Measures

Name	Time	Method
Time to recovery of peripheral capillary oxygen saturation (SpO2) from baseline	Baseline to Day 28

Secondary Outcome Measures

Name	Time	Method
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
Change in inflammation indicators (CRP or IL-6 etc.) from baseline	Baseline to Day 28
Improvement in body temperature	Baseline to Day 28
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
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 attain an improvement of 1 point on the ordinal scale	Baseline to Day 28
Time to get categories 1 to 4 in the 8-points ordinal scale	Baseline to Day 28

Trial Locations

Locations (12)

Government Medical College and Hospital; 🇮🇳 Pune, India

Asgar Ali Hospital; 🇧🇩 Dhaka, Bangladesh

Hospital Universitario de la Princesa; 🇪🇸 Madrid, Spain

Bangladesh Specialized Hospital; 🇧🇩 Dhaka, Bangladesh

Hospital Universitario Fundación Díaz; 🇪🇸 Madrid, Spain

RSUD Cengkareng(Cengkareng General Hospital); 🇮🇩 Jakarta, Jakrata, Indonesia

RSUD Pasar Minggu(Pasar Minggu General Hospital); 🇮🇩 Jakarta, Indonesia

RSUP Persahabatan(Persahabatan General Hospital); 🇮🇩 Jakarta, Indonesia

Noble Hospital Pvt Ltd; 🇮🇳 Nagpur, India

Southwest Hospital Chongqing; 🇨🇳 Chongqing, Chongqing, China

Hospital Universitario 12 De Octubre; 🇪🇸 Madrid, Spain

Hospital Universitario Clínico San Carlos; 🇪🇸 Madrid, Spain