Open-label Trial to Assess the Efficacy and Safety of Inhalation Use of the Approved Drug Surfactant-BL (Biosurf LLC, Russia) as a Part of Complex Therapy of Acute Respiratory Distress Syndrome (ARDS) in Patients With SARS-CoV-2 Coronavirus Infection (COVID-19)
试验速览
- 阶段
- 不适用
- 发起方
- Biosurf LLC.
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Mean duration of oxygen therapy (days) in the treatment group and in the control group.
研究概览
简要总结
The purpose of this study is to prove the efficacy and safety Surfactant-BL, administered by inhalation in adult hospitalized patients with ARDS due to COVID-19.
详细描述
The efficacy and safety of Surfactant-BL will be evaluated in terms of mean duration of oxygen therapy (days) after hospitalization, in adult patients with ARDS due to SARS-COV-19 infection.
Adult patients with COVID-19 induced respiratory failure will be receive either standard treatment or standard treatment plus Surfactant-BL.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent for participation in the study.
- •Male of female ≥18 and ≤ 75 years of age.
- •Body-mass index (BMI) ≤ 40 kg/m
- •Probable (the presence of a characteristic clinical findings of COVID-19 in combination with characteristic changes in the lungs according to computer tomography (CT) data) or confirmed (according to the results of laboratory tests for the presence of SARS-CoV-2 RNA using nucleic acid amplification methods) diagnosis of COVID-
- •ARDS diagnosed within 24 hours prior to screening and confirmed at screening according to the following criteria (adapted Berlin criteria):
- •bilateral darkening of the pulmonary fields (infiltration, pulmonary edema) on the chest CT, which cannot be fully explained by pleural effusion, lung tissue atelectasis, tumor or other neoplasms;
- •nature of pulmonary infiltrates: respiratory failure not associated with heart failure or fluid overload;
- •oxygenation index (РаО2/FiO2 ratio): 150 mm hg < РаО2/FiO2 ≤ 300 mm hg at the positive end-expiratory pressure (PEEP) or the continuous positive air pressure (CPAP) ≥ 5 cm H2O.
- •Oxygen saturation of the blood according to pulseoximetry (SpO2) ≤ 93 % in ambient air.
- •No indications for immediate tracheal intubation and artificial lung ventilation (ALV).
- •Negative pregnancy test result (applicable to female patients with preserved breeding potential).
排除标准
- •ARDS due to the other viral infections.
- •Non-pulmonary ARDS.
- •Comorbidities continuing at the time of the screening or a history of comorbidities that increase the risk of patient transfer to ALV or may be fatal within 3 months, including but not limited to the following:
- •Any autoimmune diseases.
- •Resistant hypertension.
- •A history of stable ischemic heart disease, chronic heart failure (NYHA class III / IV) or unstable angina.
- •Congenital / acquired QT interval prolongation and / or history of the risk factors for QT interval prolongation.
- •Tuberculosis.
- •Suspected active uncontrolled bacterial, fungal, viral, or other infections (other than COVID-19).
- •Chronic kidney disease stage 4 or the need for hemodialysis / peritoneal dialysis.
- •Multiple organ dysfunction syndrome.
- •Patients with HIV infection, viral hepatitis B and C.
- •History of organ transplantation.
- •History of conditions requiring ALV.
- •Idiosyncrasy of study drug components.
- •Pregnancy, lactation.
- •Participation in any interventional clinical trial of any drug product at the time of the screening.
研究组 & 干预措施
1 cohort
Patients with mild ARDS, who are on spontaneous breathing.
Patients who receive surfactant-BL through a mesh-nebulizer combined with the standard COVID-19 therapy, oxygen therapy according to the following scheme: inhalation of surfactant emulsion at 150 mg every 12 hours on the 1st, 2nd, 3rd, 4th and 5th days of the treatment period, inclusive.
干预措施: Surfactant (Drug)
2 cohort
Patients with moderate ARDS, who are on spontaneous breathing.
Patients who receive surfactant-BL through a mesh-nebulizer combined with the standard COVID-19 therapy, oxygen therapy according to the following scheme: inhalation of surfactant emulsion at 150 mg every 12 hours on the 1st, 2nd, 3rd, 4th and 5th days of the treatment period, inclusive.
干预措施: Surfactant (Drug)
3 cohort
Patients with mild ARDS, receiving NIV and high-flow oxygen therapy.
Patients who receive surfactant-BL through a mesh-nebulizer combined with the standard COVID-19 therapy, oxygen therapy, NIV and high-flow oxygen therapy according to the following scheme: inhalation of surfactant emulsion at 150 mg every 12 hours on the 1st, 2nd, 3rd, 4th and 5th days of the treatment period, inclusive.
干预措施: Surfactant (Drug)
4 cohort
Patients with moderate ARDS, receiving NIV and high-flow oxygen therapy.
Patients who receive surfactant-BL through a mesh-nebulizer combined with the standard COVID-19 therapy, oxygen therapy, NIV and high-flow oxygen therapy according to the following scheme: inhalation of surfactant emulsion at 150 mg every 12 hours on the 1st, 2nd, 3rd, 4th and 5th days of the treatment period, inclusive.
干预措施: Surfactant (Drug)
结局指标
主要结局
Mean duration of oxygen therapy (days) in the treatment group and in the control group.
时间窗: within 5 days after the start of treatment
次要结局
- The proportion of patients who required ALV within 5 days after the start of treatment.(within 5 days after the start of treatment)
- Change from baseline in PaO2/FiO2 ratio dynamics within 5 days after the start of treatment.(within 5 days after the start of treatment)
- Change from baseline in SpO2 dynamics within 5 days after the start of treatment.(within 5 days after the start of treatment)
- Proportion of patients who achieved an oxygenation index (PaO2/FiO2) of > 300 mm hg.(within 5 days after the start of treatment)
- Proportion of patients dead of any reason within 30 days after the start of treatment.(within 30 days after the start of treatment)
- Time to patient transfer to mechanically ventilated.(within 30 days after the start of treatment)
- Change from baseline in leukocytes within 5 days after the start of treatment.(within 5 days after the start of treatment)
- Change from the baseline in the severity assessment of the patient's condition according to the NEWS-II scale within 5 days after the start of treatment.(within 5 days after the start of treatment)
- Change from baseline in CRP within 5 days after the start of treatment.(within 5 days after the start of treatment)
- Change from baseline in lymphocytes within 5 days after the start of treatment.(within 5 days after the start of treatment)
- Change from baseline in ferritin within 5 days after the start of treatment.(within 5 days after the start of treatment)
- Change from baseline in D-dimer within 5 days after the start of treatment.(within 5 days after the start of treatment)