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.
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.
Study Type
OBSERVATIONAL
Enrollment
120
Inhalation of surfactant emulsion at 150 mg
FSAEI of Higher Education I.M. Sechenov First Moscow State Medical University
Moscow, Russia
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
The proportion of patients who required ALV within 5 days after the start of treatment.
Time frame: within 5 days after the start of treatment
Change from baseline in PaO2/FiO2 ratio dynamics within 5 days after the start of treatment.
Time frame: within 5 days after the start of treatment
Change from baseline in SpO2 dynamics within 5 days after the start of treatment.
Time frame: within 5 days after the start of treatment
Proportion of patients who achieved an oxygenation index (PaO2/FiO2) of > 300 mm hg.
Time frame: within 5 days after the start of treatment
Proportion of patients dead of any reason within 30 days after the start of treatment.
Time frame: within 30 days after the start of treatment
Time to patient transfer to mechanically ventilated.
Time frame: within 30 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.
Time frame: within 5 days after the start of treatment
Change from baseline in leukocytes within 5 days after the start of treatment.
Time frame: within 5 days after the start of treatment
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Change from baseline in lymphocytes within 5 days after the start of treatment.
Time frame: within 5 days after the start of treatment
Change from baseline in CRP within 5 days after the start of treatment.
Time frame: within 5 days after the start of treatment
Change from baseline in ferritin within 5 days after the start of treatment.
Time frame: within 5 days after the start of treatment
Change from baseline in D-dimer within 5 days after the start of treatment.
Time frame: within 5 days after the start of treatment