COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04449588

Du Zhouqi

duzhouqi@staidson.com

2020-06-29

Unknown

RCT

Randomized

Parallel

Open label

multi-center

Treatment

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.

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) pregnant or lactating woman. subjects who have participated in other interventional clinical trials in the last 3 months or during this trial. any other circumstances that the investigator considers inappropriate for the participation in this study.

2

Staidson (Beijing) Biopharmaceuticals Co., Ltd

18

80

Bangladesh;China;India;Indonesia;Spain

Severe disease at enrollment

6: Severe disease at enrollment

368

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

None

Phase 2/Phase 3

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