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

NCT04568018 | Unknown

• 1 other identifier: Sur/ARDS-2020
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

ARDS Due to COVID-19

Keywords

Surfactant; ARDS; COVID-19

Outcome Measures

Primary Outcomes (1)

• Mean duration of oxygen therapy (days) in the treatment group and in the control group.

  within 5 days after the start of treatment

Secondary Outcomes (12)

• 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

Other Outcomes (4)

• 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

Study Arms (4)

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

Surfactant DRUG

Inhalation of surfactant emulsion at 150 mg

Also known as: Surfactant-BL

1 cohort; 2 cohort; 3 cohort; 4 cohort

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biosurf LLC.: lead

Study Sites (1)

FSAEI of Higher Education I.M. Sechenov First Moscow State Medical University

Moscow, 119991, Russia

Location

MeSH Terms

Conditions

COVID-19

Interventions

Surface-Active Agents

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Specialty Uses of Chemicals; Chemical Actions and Uses

Study Officials

• Sergey Avdeev, D.M.S.

  FSAEI of Higher Education I.M. Sechenov First Moscow State Medical University (Sechenov University)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2020
• First Posted: September 29, 2020
• Study Start: July 3, 2020
• Primary Completion: October 31, 2021
• Study Completion: December 1, 2021
• Last Updated: July 21, 2021

Record last verified: 2021-07

Locations

RU (1)