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)
Overview
- Phase
- Not Applicable
- Intervention
- Surfactant
- Conditions
- ARDS Due to COVID-19
- Sponsor
- Biosurf LLC.
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Mean duration of oxygen therapy (days) in the treatment group and in the control group.
- Last Updated
- 4 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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).
Exclusion Criteria
- •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.
Arms & Interventions
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.
Intervention: Surfactant
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.
Intervention: Surfactant
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.
Intervention: Surfactant
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.
Intervention: Surfactant
Outcomes
Primary Outcomes
Mean duration of oxygen therapy (days) in the treatment group and in the control group.
Time Frame: within 5 days after the start of treatment
Secondary Outcomes
- 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)