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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • Russian Federation
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 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.
Drug: Surfactant
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.
Drug: Surfactant
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.
Drug: Surfactant
Inhalation of surfactant emulsion at 150 mg
Other Names:
  • Surfactant-BL

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Biosurf LLC.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 3, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 31, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 18, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 25, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 29, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 21, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 20, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Sur/ARDS-2020

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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