CClinicalTrials.gg
Sign In
Status unknownNCT04568018Updated Jul 21, 2021

Surfactant-BL in Adult Acute Respiratory Distress Syndrome Due to COVID-19

An observational study in ARDS Due to COVID-19, sponsored by Biosurf LLC.. Status unknown at 1 site in Russian Federation. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-07-21.

Sponsored by Biosurf LLC. · Observational

The sponsor has not verified this record recently (last verified Jul 2021), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
120
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • ARDS Due to COVID-19

Keywords

  • Surfactant
  • ARDS
  • COVID-19
03

In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's enrollment of 120 is below the median of 261 across 3,136 observational studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

This is the only study on the registry with Biosurf LLC. as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Sampling method
Probability sample

Study population

Adult patients with ARDS due to SARS-COV-19 infection

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
120 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • 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

  • 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

  • 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

Interventions

  • DrugSurfactant

    Inhalation of surfactant emulsion at 150 mg

    Also known as: Surfactant-BL

06

What researchers measure

Primary outcomes

  1. 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

  1. 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

  2. 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

  3. Change from baseline in SpO2 dynamics within 5 days after the start of treatment.

    Time frame: within 5 days after the start of treatment

  4. Proportion of patients who achieved an oxygenation index (PaO2/FiO2) of > 300 mm hg.

    Time frame: within 5 days after the start of treatment

  5. 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

  6. Time to patient transfer to mechanically ventilated.

    Time frame: within 30 days after the start of treatment

  7. 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

  8. Change from baseline in leukocytes within 5 days after the start of treatment.

    Time frame: within 5 days after the start of treatment

  9. Change from baseline in lymphocytes within 5 days after the start of treatment.

    Time frame: within 5 days after the start of treatment

  10. Change from baseline in CRP within 5 days after the start of treatment.

    Time frame: within 5 days after the start of treatment

  11. Change from baseline in ferritin within 5 days after the start of treatment.

    Time frame: within 5 days after the start of treatment

  12. Change from baseline in D-dimer within 5 days after the start of treatment.

    Time frame: within 5 days after the start of treatment

Other outcomes

  1. Rate of early terminations due to AE/SAE.

    Time frame: within 30 days after the start of treatment

  2. 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

  3. 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

  4. Proportion of deaths in each group.

    Time frame: within 30 days after the start of treatment

07

Study locations

1 site
  • FSAEI of Higher Education I.M. Sechenov First Moscow State Medical University
    Moscow, 119991, Russian Federation
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 21, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04568018
Lead sponsor
Biosurf LLC.
Responsible party
Sponsor
First posted
Sep 29, 2020
Start date
Jul 3, 2020
Primary completion
Oct 31, 2021 (estimated)
Completion
Dec 2021 (estimated)
Last update
Jul 21, 2021

Study contacts

Sergey Avdeev, D.M.S.
principal investigator · FSAEI of Higher Education I.M. Sechenov First Moscow State Medical University (Sechenov University)

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

COVID-19→

Start the discussion