- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04568018
Surfactant-BL in Adult Acute Respiratory Distress Syndrome Due to COVID-19
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)
Study Overview
Status
Conditions
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
Enrollment (Actual)
Contacts and Locations
Study Locations
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Moscow, Russian Federation, 119991
- FSAEI of Higher Education I.M. Sechenov First Moscow State Medical University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
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:
|
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:
|
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:
|
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:
|
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
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within 5 days after the start of treatment
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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
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within 5 days after the start of treatment
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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
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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
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within 30 days after the start of treatment
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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
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within 30 days after the start of treatment
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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
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
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Respiration Disorders
- Pneumonia, Viral
- Pneumonia
- Lung Diseases
- Infant, Newborn, Diseases
- Lung Injury
- Infant, Premature, Diseases
- COVID-19
- Respiratory Distress Syndrome
- Respiratory Distress Syndrome, Newborn
- Acute Lung Injury
- Respiratory System Agents
- Pulmonary Surfactants
Other Study ID Numbers
- Sur/ARDS-2020
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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