Surfactant-BL in Adult Acute Respiratory Distress Syndrome Due to COVID-19
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04568018 |
Recruitment Status :
Active, not recruiting
First Posted : September 29, 2020
Last Update Posted : July 21, 2021
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment |
---|---|
ARDS Due to COVID-19 | Drug: Surfactant |
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 |
Actual Enrollment : | 120 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | 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) |
Actual Study Start Date : | July 3, 2020 |
Estimated Primary Completion Date : | October 31, 2021 |
Estimated Study Completion Date : | December 2021 |

Group/Cohort | Intervention/treatment |
---|---|
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. |
Drug: Surfactant
Inhalation of surfactant emulsion at 150 mg
Other Name: Surfactant-BL |
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. |
Drug: Surfactant
Inhalation of surfactant emulsion at 150 mg
Other Name: Surfactant-BL |
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. |
Drug: Surfactant
Inhalation of surfactant emulsion at 150 mg
Other Name: Surfactant-BL |
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. |
Drug: Surfactant
Inhalation of surfactant emulsion at 150 mg
Other Name: Surfactant-BL |
- 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 ]
- 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 ]
- Rate of early terminations due to AE/SAE. [ Time Frame: within 30 days after the start of treatment ]
- Proportion of patients with AEs / SAEs with highly-reliable causal relationship (certain, probable or possible) with the current WHO therapy according to the researcher's opinion. [ Time Frame: within 30 days after the start of treatment ]
- Proportion of patients in each group with grade 3-4 AEs (CTCAE c 4.0 and higher) with highly-reliable causal relationship (certain, probable or possible) with the current WHO therapy according to the researcher's opinion. [ Time Frame: within 30 days after the start of treatment ]
- Proportion of deaths in each group. [ Time Frame: within 30 days after the start of treatment ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Sampling Method: | Probability Sample |
Inclusion Criteria:
- Informed consent for participation in the study.
- Male of female ≥18 and ≤ 75 years of age.
- Body-mass index (BMI) ≤ 40 kg/m2.
- 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.
-
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).
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.
- Multiple organ dysfunction syndrome.
- Cancer.
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04568018
Russian Federation | |
FSAEI of Higher Education I.M. Sechenov First Moscow State Medical University | |
Moscow, Russian Federation, 119991 |
Principal Investigator: | Sergey Avdeev, D.M.S. | FSAEI of Higher Education I.M. Sechenov First Moscow State Medical University (Sechenov University) |
Responsible Party: | Biosurf LLC. |
ClinicalTrials.gov Identifier: | NCT04568018 |
Other Study ID Numbers: |
Sur/ARDS-2020 |
First Posted: | September 29, 2020 Key Record Dates |
Last Update Posted: | July 21, 2021 |
Last Verified: | July 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Surfactant ARDS COVID-19 |
COVID-19 Respiratory Distress Syndrome Respiratory Distress Syndrome, Newborn Acute Lung Injury Respiratory Tract Infections Infections Pneumonia, Viral Pneumonia Virus Diseases Coronavirus Infections Coronaviridae Infections |
Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases Respiration Disorders Infant, Premature, Diseases Infant, Newborn, Diseases Lung Injury Pulmonary Surfactants Respiratory System Agents |