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.
Drug: Surfactant
Inhalation of surfactant emulsion at 150 mg
Other Name: Surfactant-BL
Inclusion Criteria:
1. Informed consent for participation in the study.
2. Male of female ≥18 and ≤ 75 years of age.
3. Body-mass index (BMI) ≤ 40 kg/m2.
4. 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-19.
5. 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.
6. Oxygen saturation of the blood according to pulseoximetry (SpO2) ≤ 93 % in ambient
air.
7. No indications for immediate tracheal intubation and artificial lung ventilation
(ALV).
8. Negative pregnancy test result (applicable to female patients with preserved breeding
potential).
Exclusion Criteria:
1. ARDS due to the other viral infections.
2. Non-pulmonary ARDS.
3. 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.
- Cancer.
4. Patients with HIV infection, viral hepatitis B and C.
5. History of organ transplantation.
6. History of conditions requiring ALV.
7. Idiosyncrasy of study drug components.
8. Pregnancy, lactation.
9. Participation in any interventional clinical trial of any drug product at the time of
the screening.
FSAEI of Higher Education I.M. Sechenov First Moscow State Medical University
Moscow, Russian Federation
Sergey Avdeev, D.M.S., Principal Investigator
FSAEI of Higher Education I.M. Sechenov First Moscow State Medical University (Sechenov University)