ARDS Due to COVID-19NCT04568018
Surfactant-BL in Adult Acute Respiratory Distress Syndrome Due to COVID-19
An observational study of ARDS Due to COVID-19, run by Biosurf LLC. at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- ARDS Due to COVID-19
- What is being tested?
- Surfactant
- How many people
- 120 participants
- Where
- 1 siteRussia
- Study dates
- 3 Jul 2020to Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Adult, Older adult
Study population: Adult patients with ARDS due to SARS-COV-19 infection
Who may be able to join
- 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;
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- 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).
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Russia1 site
FSAEI of Higher Education I.M. Sechenov First Moscow State Medical University
Moscow, 119991
About this study
Official title: 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.
Read the 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.
- Conditions
- ARDS Due to COVID-19
- Being tested
- Surfactant
- Keywords
- Surfactant, ARDS, COVID-19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurfactantDrug
Also called Surfactant-BL
Inhalation of surfactant emulsion at 150 mg
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: Surfactant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean duration of oxygen therapy (days) in the treatment group and in the control group.
Measured: 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.
Measured: within 5 days after the start of treatment
Change from baseline in PaO2/FiO2 ratio dynamics within 5 days after the start of treatment.
Measured: within 5 days after the start of treatment
Change from baseline in SpO2 dynamics within 5 days after the start of treatment.
Measured: within 5 days after the start of treatment
Proportion of patients who achieved an oxygenation index (PaO2/FiO2) of > 300 mm hg.
Measured: within 5 days after the start of treatment
Proportion of patients dead of any reason within 30 days after the start of treatment.
Measured: within 30 days after the start of treatment
Time to patient transfer to mechanically ventilated.
Measured: 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.
Measured: within 5 days after the start of treatment
Change from baseline in leukocytes within 5 days after the start of treatment.
Measured: within 5 days after the start of treatment
Change from baseline in lymphocytes within 5 days after the start of treatment.
Measured: within 5 days after the start of treatment
Change from baseline in CRP within 5 days after the start of treatment.
Measured: within 5 days after the start of treatment
Change from baseline in ferritin within 5 days after the start of treatment.
Measured: within 5 days after the start of treatment
Change from baseline in D-dimer within 5 days after the start of treatment.
Measured: within 5 days after the start of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2020
- Study start3 Jul 2020
- Primary completion31 Oct 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ARDS Due to COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biosurf LLC.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sergey Avdeev, D.M.S., Principal investigator, FSAEI of Higher Education I.M. Sechenov First Moscow State Medical University (Sechenov University)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04568018
- Sponsor's protocol ID
- Sur/ARDS-2020
- Status last verified
- Jul 2021
- First submitted
- 18 Sep 2020
- Last updated
- 21 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT04568018
- Acronym / sponsor ID
- Sur/ARDS-2020
- Conditions
- ARDS Due to COVID-19
- Keywords
- Surfactant, ARDS, COVID-19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Biosurf LLC.Industry (pharma, biotech, devices)
- Study start
- 3 Jul 2020 (actual)
- Primary completion
- 31 Oct 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 29 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 cohort | – | Drug: SurfactantPatients 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. |
| 2 cohort | – | Drug: SurfactantPatients 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. |
| 3 cohort | – | Drug: SurfactantPatients 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. |
| 4 cohort | – | Drug: SurfactantPatients 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult patients with ARDS due to SARS-COV-19 infection
Key inclusion criteria (11 listed)
- 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):
Key exclusion criteria (18 listed)
- 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:
- Patients with HIV infection, viral hepatitis B and C.
- History of organ transplantation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SurfactantAlso: Surfactant-BLInhalation of surfactant emulsion at 150 mg | Drug | 1 cohort, 2 cohort, 3 cohort, 4 cohort |
Primary outcome
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
12 secondary outcomes
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
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
Change from baseline in SpO2 dynamics within 5 days after the start of treatment.
Time frame: 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
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
Time to patient transfer to mechanically ventilated.
Time frame: 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
Change from baseline in leukocytes within 5 days after the start of treatment.
Time frame: 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
Change from baseline in CRP within 5 days after the start of treatment.
Time frame: 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
Change from baseline in D-dimer within 5 days after the start of treatment.
Time frame: within 5 days after the start of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sergey Avdeev, D.M.S. principal investigator
FSAEI of Higher Education I.M. Sechenov First Moscow State Medical University (Sechenov University)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ARDS Due to COVID-19, run by Biosurf LLC. at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2021.