COVID-19 MedDRA version: 23.0 Level: PT Classification code 10051905 Term: Coronavirus infection System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Product Name: BDB-001
Product Code: BDB-001
Pharmaceutical Form: Solution for infusion in administration system
INN or Proposed INN: not available
Current Sponsor code: BDB-001
Other descriptive name:
Sponsors
Staidson (Beijing) Biopharmaceutical Co., Ltd. and Beijing Defengrui Biological Technology Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age: 18-80 years old; Gender: male and/or female. 2. Subject with confirmed severe COVID-19 in less than 5 days who meets any of the following criteria: a. Respiratory distress, RR =30 times/min b. In resting state, finger oxygen saturation =93% c. Oxygenation Index (PaO2/FiO2)=300 mmHg (1 mmHg = 0.133kpa) in supine position d. Pulmonary imaging shows lesion progression >50% within 24 – 48 hours. 3. The informed consent signed. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 35 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 25
Exclusion criteria
Exclusion criteria: 1. Subjects already progressed into COVID-19 critically severe type (including respiratory failure requiring mechanical ventilation, or shock, or combined with other organ failure) or sepsis and sepsis shock. 2. History of severe lung disease such as chronic obstructive pulmonary disease (moderate to severe type), lung cancers, tuberculosis; history of severe heart disease: unstable angina pectoris, myocardial infarction, postcardiac surgery, cardiac function =grade 3 (NYHA Classification); history of severe liver diseases (e.g. Child-Pugh score =grade C); history of severe kidney diseases, such as renal insufficiency (GFR =15 mL/min/1.73m2); immune deficiencies or immune- related diseases : including some autoimmune diseases, IgG4-related diseases, allergic alveolitis, vasculitis; malignancies. 3. Clear diagnosis of combined bacterial, fungal infections which would disturb the study results according to the opinion of the investigator 4. Subjects on current treatment with a complement inhibitor such as eculizumab. 5. Subjects with a history of hypersensitivity to any ingredient contained in the study drug 6. A subject has used the following drugs within 2 weeks prior to screening procedures: • Calcineurin inhibitors (e.g., ciclosporin, tacrolimus, etc.) • Immunosuppressant (e.g., everolimus, sirolimus, etc.) • Anti-metabolic drugs (e.g., mycophenolate mofetil, mycophenolate, purine sulphate, etc.) 7. Positive serum pregnancy test at screening in women of child-bearing potential. A woman is considered of childbearing potential, i.e. fertile, following menarche (first menstrual cycle) and until becoming post-menopausal unless permanently sterile: permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. Women of child-bearing potential must abstain from sexual intercourse or use effective birth control methods for 1 month after their participation in the study ends. Men with a female partner capable of having children must abstain from sexual intercourse or use effective birth control methods for 3 months after their participation in the study ends. Such methods include: • Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal) • Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable) • Intrauterine device • Intrauterine hormone-releasing system • Bilateral tubal occlusion • Vasectomized partner 8. Any other circumstances that the investigator considers inappropriate for the participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Percentage of patient number (%) achieve recovery [Oxygenation index =300mmHg from baseline (day 1 prior to investigational drug administration), in supine position OR discharge from hospital].;Timepoint(s) of evaluation of this end point: days 3, 7, 11, 14.;Main Objective: Efficacy and safety assessments of BDB-001 for infusion in treating patients with progressive severe COVID-19.;Secondary Objective: Not applicable | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Time for oxygenation index recovery to normal (=300mmHg) or discharge from hospital based on the record on day 3,7,11,14. 2. Mean change in the oxygenation index 3. Mechanical ventilation time 4. Oxygen therapy 5. Change in inflammation indicators (CRP or IL-6) from baseline. 6. Improvement in body temperature 7. 28-day all-cause mortality rate 8. Mean change from baseline in the clinical improvement ordinal scale recommended by the WHO R&D Blueprint during treatment period. 9. Improvement in the ordinal scale at D3, D7, D11 & D14;Timepoint(s) of evaluation of this end point: days 3, 7, 11, 14 and at the end of the study | — |
Countries
Spain
Contacts
Public ContactLixin Jiang
Staidson Biopharma Inc.
Outcome results
None listed