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

July 20, 2021 updated by: Biosurf LLC.

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)

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.

Study Overview

Status

Active, not recruiting

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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.

Inhalation of surfactant emulsion at 150 mg
Other Names:
  • 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.

Inhalation of surfactant emulsion at 150 mg
Other Names:
  • 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.

Inhalation of surfactant emulsion at 150 mg
Other Names:
  • 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.

Inhalation of surfactant emulsion at 150 mg
Other Names:
  • Surfactant-BL

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
within 5 days after the start of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
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
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
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
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
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
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
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
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
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
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
within 5 days after the start of treatment

Other Outcome Measures

Outcome Measure
Time Frame
Rate of early terminations due to AE/SAE.
Time Frame: within 30 days after the start of treatment
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
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
within 30 days after the start of treatment
Proportion of deaths in each group.
Time Frame: within 30 days after the start of treatment
within 30 days after the start of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Sergey Avdeev, D.M.S., FSAEI of Higher Education I.M. Sechenov First Moscow State Medical University (Sechenov University)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 3, 2020

Primary Completion (Anticipated)

October 31, 2021

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

September 18, 2020

First Submitted That Met QC Criteria

September 25, 2020

First Posted (Actual)

September 29, 2020

Study Record Updates

Last Update Posted (Actual)

July 21, 2021

Last Update Submitted That Met QC Criteria

July 20, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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