Surfactant-BL in Adult Acute Respiratory Distress Syndrome Due to COVID-19
Study Details
Study Description
Brief 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.
Condition or Disease | Intervention/Treatment | Phase |
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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 Design
Arms and Interventions
Arm | Intervention/Treatment |
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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:
|
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:
|
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:
|
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:
|
Outcome Measures
Primary Outcome Measures
- Mean duration of oxygen therapy (days) in the treatment group and in the control group. [within 5 days after the start of treatment]
Secondary Outcome Measures
- The proportion of patients who required ALV 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. [within 5 days after the start of treatment]
- Change from baseline in SpO2 dynamics 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. [within 5 days after the start of treatment]
- Proportion of patients dead of any reason within 30 days after the start of treatment. [within 30 days after the start of treatment]
- Time to patient transfer to mechanically ventilated. [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. [within 5 days after the start of treatment]
- Change from baseline in leukocytes 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. [within 5 days after the start of treatment]
- Change from baseline in CRP 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. [within 5 days after the start of treatment]
- Change from baseline in D-dimer within 5 days after the start of treatment. [within 5 days after the start of treatment]
Other Outcome Measures
- Rate of early terminations due to AE/SAE. [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. [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. [within 30 days after the start of treatment]
- Proportion of deaths in each group. [within 30 days after the start of treatment]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Informed consent for participation in the study.
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Male of female ≥18 and ≤ 75 years of age.
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Body-mass index (BMI) ≤ 40 kg/m2.
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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.
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ARDS diagnosed within 24 hours prior to screening and confirmed at screening according to the following criteria (adapted Berlin criteria):
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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;
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nature of pulmonary infiltrates: respiratory failure not associated with heart failure or fluid overload;
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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.
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Oxygen saturation of the blood according to pulseoximetry (SpO2) ≤ 93 % in ambient air.
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No indications for immediate tracheal intubation and artificial lung ventilation (ALV).
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Negative pregnancy test result (applicable to female patients with preserved breeding potential).
Exclusion Criteria:
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ARDS due to the other viral infections.
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Non-pulmonary ARDS.
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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:
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Any autoimmune diseases.
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Resistant hypertension.
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A history of stable ischemic heart disease, chronic heart failure (NYHA class III / IV) or unstable angina.
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Congenital / acquired QT interval prolongation and / or history of the risk factors for QT interval prolongation.
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Tuberculosis.
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Suspected active uncontrolled bacterial, fungal, viral, or other infections (other than COVID-19).
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Chronic kidney disease stage 4 or the need for hemodialysis / peritoneal dialysis.
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Multiple organ dysfunction syndrome.
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Cancer.
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Patients with HIV infection, viral hepatitis B and C.
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History of organ transplantation.
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History of conditions requiring ALV.
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Idiosyncrasy of study drug components.
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Pregnancy, lactation.
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Participation in any interventional clinical trial of any drug product at the time of the screening.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | FSAEI of Higher Education I.M. Sechenov First Moscow State Medical University | Moscow | Russian Federation | 119991 |
Sponsors and Collaborators
- Biosurf LLC.
Investigators
- Principal Investigator: Sergey Avdeev, D.M.S., FSAEI of Higher Education I.M. Sechenov First Moscow State Medical University (Sechenov University)
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Sur/ARDS-2020