COVID-19 Pneumonia
Conditions
Keywords
COVID-19, Severe Pneumonia, ALI/ARDS
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).
Interventions
BDB-001 Injection+Conventional treatment
OTHERConventional treatment
Conventional treatment only. Local guidelines should be integrated to choose the best supportive care.
Sponsors
Beijing Defengrui Biotechnology Co. Ltd
Staidson (Beijing) Biopharmaceuticals Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to recovery of peripheral capillary oxygen saturation (SpO2) from baseline | Baseline to Day 28 |
Secondary
| Measure | Time frame |
|---|---|
| Mean change of PaO2/FiO2 | Baseline to Day 28 |
| Mechanical ventilation time | Baseline to Day 28 |
| Time of oxygen therapy | 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 |
| 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 get categories 1 to 4 in the 8-points ordinal scale | Baseline to Day 28 |
| Time to attain an improvement of 1 point on the ordinal scale | Baseline to Day 28 |
| Change in inflammation indicators (CRP or IL-6 etc.) from baseline | Baseline to Day 28 |
Countries
Bangladesh, China, India, Indonesia, Spain
Outcome results
None listed