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

Staidson (Beijing) Biopharmaceuticals Co., Ltd12 sites in 5 countries369 target enrollmentJuly 23, 2020

ConditionsCOVID-19 Pneumonia

InterventionsBDB-001 Injection Conventional treatment

DrugsBDB-001 Injection

Overview

Phase: Phase 2
Intervention: BDB-001 Injection
Conditions: COVID-19 Pneumonia
Sponsor: Staidson (Beijing) Biopharmaceuticals Co., Ltd
Enrollment: 369
Locations: 12
Primary Endpoint: Time to recovery of peripheral capillary oxygen saturation (SpO2) from baseline
Status: Terminated
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

July 23, 2020

End Date

March 26, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Staidson (Beijing) Biopharmaceuticals Co., Ltd

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•18 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.

Exclusion Criteria

•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)

Arms & Interventions

Treatment group

Intervention: BDB-001 Injection

Control group

Intervention: Conventional treatment

Outcomes

Primary Outcomes

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

Time Frame: Baseline to Day 28

Secondary Outcomes

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)
Change in inflammation indicators (CRP or IL-6 etc.) from baseline(Baseline to Day 28)
Improvement in body temperature(Baseline to Day 28)
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)
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)