Tahapan Penelitian : Recruit
Mitra Pelaksana:
RSUP Persahabatan, RSUD Pasar Minggu, RSUD Cengkareng, RS Islam Jakarta Cempaka Putih, RS Kramat 128, RS Yarsi, RSPAD Gatot Soebroto, RS Kartika Pulo Mas, dan RS Universitas Indonesia
No Registry
Tanggal Input Registry : 29-03-2022

1. Time to recovery of peripheral capillary oxygen saturation (SpO2) from baseline [SpO2 ≥ 95% for sustained 48 hours with nasal cannula at ≤ 3L/min of oxygen]. 2. The subject will be defined to meet the primary endpoint if he is discharged from hospital according to local guideline of COVID-19
1. Percentage of subjects achieving improvement in SpO2 [SpO2 ≥ 95% for sustained 48 hours with nasal cannula at ≤ 3L/min of oxygen] 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. Mean change from baseline in the clinical improvement ordinal scale recommended by the WHO R&D Blueprint during treatment period 8. Improvement in the ordinal scale at D3, 7, 11 & D14 9. Time to get categories 1 to 4 in the 8-points ordinal scale 10. Time to attain an improvement of 1 point on the ordinal scale 11. 28-day all-cause mortality rate 12. Percentage of patients who progress to critical condition
Penilaian Efikasi dan Keamanan Injeksi BDB-001 untuk Pengobatan COVID-19 Berat dan Progresif: Suatu Uji Klinik Fase II, Multisenter, Berpembanding, Paralel, Acak dan Terbuka
a. Treatment group: conventional treatment + BDB-001 Injection b. Control group: conventional treatment

Inclusion Criteria:

1. 18 years old ≤ age ≤ 80 years old, men or women. 2. Confirmed new coronavirus (SARS-CoV-2) infection, and meet at least one of the following criteria: (1) 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 (room air), 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. (2) 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:

1. Subjects already progressed into COVID-19 critically severe type (Critical severe standards refer to FDA guidelines, as shown in Appendix 4) or sepsis and sepsis shock. 2. Concomitant with the following situation (1) Severe lung disease such as chronic obstructive pulmonary disease(moderate to severe type), lung cancers, tuberculosis; (2) Severe heart disease: unstable angina pectoris, myocardial infarction, cardiac function ≥ grade 3 (NYHA Classification); or had severe cardiovascular and cerebrovascular diseases or had undergone heart surgery within 6 months before randomization; (3) Severe liver diseases (e.g. Child-Pugh score ≥ grade C); (4) Severe kidney diseases, such as renal insufficiency (GFR ≤ 15 mL/min/1.73m2 ); (5) Immune deficiencies or immune-related diseases : including some autoimmune diseases, IgG4-related diseases, allergic alveolitis, vasculitis; (6) Malignancies, except adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumors curatively treated with no evidence of disease for ≥ 5 years. 3. Subjects on current treatment with a complement inhibitor such as eculizumab within 1 month before randomization. 4. Subjects who are allergic to any ingredient contained in the study 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 (See Appendix 3). 7. Any other circumstances that the investigator considers inappropriate for the participation in this study. 8. Subjects who have participated in other interventional clinical trials within 3 months before using BDB-001 injection or in the process of participating in this study.
KET-557/UN.2.F1/ETIK/PPM.00.02/2020 dan 50/KEPK-RSUPP/6/2020
Master V3.0-Indonesia V5.1a, 10 June 2021
Yustina Ari Astuti dan Muh. Nashrurrokhman