COVID-19CovidSurfNCT04847375
Exogenous Surfactant Through Nebulizer Mask on Clinical Outcomes in Covid-19 Patients
A study testing exogenous surfactant in people with COVID-19 and Respiratory Distress Syndrome, run by Shahid Beheshti University of Medical Sciences.
Trial summary
Covid-19 disease is one of the most important health system challenges which is the result of the recent SARS CoV-2 virus outbreak. So far, despite the use of different types of pharmaceuticals, none has been served as a curative treatment and research is continued to find one or more effective drugs; either… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- COVID-19, Respiratory Distress Syndrome, Surface-Active Agents
- What is being tested?
- exogenous surfactant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 20 Apr 2021to 20 Sep 2021
- Phase
- Interventional
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age over 18 years
- definitive proof of COVID-19 infection by polymerase chain reaction (PCR) within 48 hours of hospital admission
- COVID-19 related Moderate ARDS following Berlin criteria definition with PaO2/FiO2 < 200 requiring what condition?
- Signed and dated informed consent form (ICF) by the subject or caregivers
Who cannot join
- known or high suspicion of pre-existing heart failure, unstable angina
- presence of severe shock with hemodynamic instability despite escalating vasopressors
- Severe, underlying pulmonary infection or severe pulmonary disease except for COVID-19 (COPD, pulmonary fibrosis, lung cancer, bacterial pneumonia, etc.)
- Diagnosis of pulmonary hemorrhage
- Pregnancy or lactation
- Other significant cause than ARDS to the respiratory failure
Show all 12Show fewer
- Age less than 18
- Age more than 80
- Need for ECMO (extracorporeal membrane oxygenation) during the study
- Anticipated transfer to another hospital within 72 hours
- Known hypersensitivity to exogenous surfactant
- Current participation or participation in another study within the last month that in the opinion of the investigator would prevent enrollment for safety purposes
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluation of the Effect of Exogenous Surfactant Through Nebulizer Mask on Clinical Outcomes in Covid-19 Patients
Covid-19 disease is one of the most important health system challenges which is the result of the recent SARS CoV-2 virus outbreak. So far, despite the use of different types of pharmaceuticals, none has been served as a curative treatment and research is continued to find one or more effective drugs; either palliative or curative ones.
One of the most important clinical problems in Covid-19 patients is lung involvement, which may causes significant sequels; leading to a main part of morbidity and/or mortality.
Read more
Surfactant is one of the drugs that can have valuable effects on the lungs, both by reducing the alveolar surface tension and by exerting immunomodulatory effects.
In a previous study by the same team, favorable effects were seen in intubated patients; however, the aim of this study was to evaluate the effect of exogenous nebulized surfactant in the pre-intubation stages of the disease.
Read the detailed description
Exogenous surfactant in neonates with clinical pulmonary distress syndrome has demonstrated pulmonary improvement; the latter being one of the most important applications of exogenous surfactant. In adults with underlying lung disease, especially Adult Respiratory Distress Syndrome (ARDS), there are controversial findings regarding the efficacy of surfactant.
However, in a previous study, it was shown that surfactant in COVID-19 patients with pulmonary intubation improved pulmonary function and gas exchange and also, reduced patient mortality.
However, none of the other repurposed drugs in COVID-19 have yet been able to prove significant effects in the treatment of patients; based on a recent study on more than 11000 COVID-19 patients (i.e. the SOLIDARITY study).
Due to the significant worldwide challnege with COVID-19, many efforts have been made in this regard, but the definitive cure has not yet been obtained, and therefore, efforts are being made to find an effective method to treat the disease and improve patients' symptoms; parallel to the efforts to increase the vaccination coverage.
- Being tested
- exogenous surfactant
- Keywords
- Covid-19, exogenous surfactant, Adult Respiratory Distress Syndrome, nebulizer
- Medical subject headings
- COVID-19, Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exogenous surfactantDrug
Nebulized Surfactant would be administered by face mask which has a nebulizer
| Study group | Role | What they receive |
|---|---|---|
| Nebulized Surfactant | Experimental | The patients in this group will receive exogenous surfactant using nebulizer mask as soon as they are admitted in the hospital (ward or emergency department) with a diagnosis of COVID-19; in addition they will receive standard care based on the national guidelines Receives: Drug: exogenous surfactant |
| Standard Care | No intervention | The patients in this group will receive standard care based on the national guidelines as soon as they are admitted in the hospital (ward or emergency department) with a diagnosis of COVID-19 |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of tracheal intubation
the frequency of patients who will be intubated due to deteriorated pulmonary function
Measured: through study completion, an average of 1 year
rate of ICU admission
the frequency of patients who will be admitted to intensive care unit due to deteriorated pulmonary function
Measured: through study completion, an average of 1 year
lowest oxygen saturation
lowest number reading in the pulse oxymetry in one of the fingers or toes
Measured: through study completion, an average of 1 year
Secondary outcomes (2)
30 days mortality
the mortality rate during the first 30 days after the first day of hospital admission
Measured: the first 30 days after hospital admission
90 days mortality
the mortality rate during the first 90 days after the first day of hospital admission
Measured: the first 90 days after hospital admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2021
- Study start20 Apr 2021 (estimated)
- Primary completion20 Jul 2021 (estimated)
- Study completion20 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Dabbagh, Shahid Beheshti University of Medical Sciences
- Investigators
- Afshin Zarghi, PhD, Study chair, Deputy of Research and Technology, Shahid Beheshti University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04847375
- Sponsor's protocol ID
- 27348
- Acronym
- CovidSurf
- Status last verified
- Apr 2021
- First submitted
- 10 Apr 2021
- Last updated
- 19 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: to be determined
Publications
Ghahremani M, Fathi M, Massoudi N, Tavana S, Fani K, Nooraee N, Malekpour Alamdari N, Besharat S, Naja Abrandabadi A, Pirsalehi A, Khabiri Khatiri MA, Amini Pouya M, Rajaei S, Dabbagh A. Exogenous Surfactant Versus Placebo in the Treatment of Moderate and Severe ARDS in COVID19: The Pilot Study of a Clinical Trial. DOI: https://doi.org/10.21203/rs.3.rs-136365/v1. Preprint.
Takian A, Raoofi A, Kazempour-Ardebili S. COVID-19 battle during the toughest sanctions against Iran. Lancet. 2020 Mar 28;395(10229):1035-1036. doi: 10.1016/S0140-6736(20)30668-1. Epub 2020 Mar 18. No abstract available.
PubMed 32199073Zhang Y, Xu J, Li H, Cao B. A Novel Coronavirus (COVID-19) Outbreak: A Call for Action. Chest. 2020 Apr;157(4):e99-e101. doi: 10.1016/j.chest.2020.02.014. Epub 2020 Feb 19. No abstract available.
PubMed 32087216Yue H, Bai X, Wang J, Yu Q, Liu W, Pu J, Wang X, Hu J, Xu D, Li X, Kang N, Li L, Lu W, Feng T, Ding L, Li X, Qi X; Gansu Provincial Medical Treatment Expert Group of COVID-19. Clinical characteristics of coronavirus disease 2019 in Gansu province, China. Ann Palliat Med. 2020 Jul;9(4):1404-1412. doi: 10.21037/apm-20-887. Epub 2020 Jul 13.
PubMed 32692208INSPIRATION Investigators; Sadeghipour P, Talasaz AH, Rashidi F, Sharif-Kashani B, Beigmohammadi MT, Farrokhpour M, Sezavar SH, Payandemehr P, Dabbagh A, Moghadam KG, Jamalkhani S, Khalili H, Yadollahzadeh M, Riahi T, Rezaeifar P, Tahamtan O, Matin S, Abedini A, Lookzadeh S, Rahmani H, Zoghi E, Mohammadi K, Sadeghipour P, Abri H, Tabrizi S, Mousavian SM, Shahmirzaei S, Bakhshandeh H, Amin A, Rafiee F, Baghizadeh E, Mohebbi B, Parhizgar SE, Aliannejad R, Eslami V, Kashefizadeh A, Kakavand H, Hosseini SH, Shafaghi S, Ghazi SF, Najafi A, Jimenez D, Gupta A, Madhavan MV, Sethi SS, Parikh SA, Monreal M, Hadavand N, Hajighasemi A, Maleki M, Sadeghian S, Piazza G, Kirtane AJ, Van Tassell BW, Dobesh PP, Stone GW, Lip GYH, Krumholz HM, Goldhaber SZ, Bikdeli B. Effect of Intermediate-Dose vs Standard-Dose Prophylactic Anticoagulation on Thrombotic Events, Extracorporeal Membrane Oxygenation Treatment, or Mortality Among Patients With COVID-19 Admitted to the Intensive Care Unit: The INSPIRATION Randomized Clinical Trial. JAMA. 2021 Apr 27;325(16):1620-1630. doi: 10.1001/jama.2021.4152.
PubMed 33734299Dabbagh A, Rajaei S, Ghahremani M, Fathi M, Massoudi N, Tavana S, Fani K, Nooraee N, Malekpour Alamdari N, Besharat S, Najafi Abrandabadi A, Pirsalehi A, Khabiri Khatiri MA. The effect of surfactant on clinical outcome of patients with COVID-19 under mechanical ventilation: A structured summary of a study protocol for a randomised controlled trial. Trials. 2020 Nov 11;21(1):919. doi: 10.1186/s13063-020-04815-z.
PubMed 33176850Alamdari NM, Afaghi S, Rahimi FS, Tarki FE, Tavana S, Zali A, Fathi M, Besharat S, Bagheri L, Pourmotahari F, Irvani SSN, Dabbagh A, Mousavi SA. Mortality Risk Factors among Hospitalized COVID-19 Patients in a Major Referral Center in Iran. Tohoku J Exp Med. 2020 Sep;252(1):73-84. doi: 10.1620/tjem.252.73.
PubMed 32908083Xu Z, Shi L, Wang Y, Zhang J, Huang L, Zhang C, Liu S, Zhao P, Liu H, Zhu L, Tai Y, Bai C, Gao T, Song J, Xia P, Dong J, Zhao J, Wang FS. Pathological findings of COVID-19 associated with acute respiratory distress syndrome. Lancet Respir Med. 2020 Apr;8(4):420-422. doi: 10.1016/S2213-2600(20)30076-X. Epub 2020 Feb 18. No abstract available.
PubMed 32085846
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Exogenous Surfactant Through Nebulizer Mask on Clinical Outcomes in Covid-19 Patients
- ClinicalTrials.gov ID
- NCT04847375
- Acronym / sponsor ID
- CovidSurf / 27348
- Keywords
- Covid-19, exogenous surfactant, Adult Respiratory Distress Syndrome, nebulizer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Shahid Beheshti University of Medical SciencesUniversity, hospital or other
- Study start
- 20 Apr 2021 (estimated)
- Primary completion
- 20 Jul 2021 (estimated)
- Study completion
- 20 Sep 2021 (estimated)
- First posted
- 19 Apr 2021 (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.
Covid-19 disease is one of the most important health system challenges which is the result of the recent SARS CoV-2 virus outbreak. So far, despite the use of different types of pharmaceuticals, none has been served as a curative treatment and research is continued to find one or more effective drugs; either palliative or curative ones.
One of the most important clinical problems in Covid-19 patients is lung involvement, which may causes significant sequels; leading to a main part of morbidity and/or mortality.
Surfactant is one of the drugs that can have valuable effects on the lungs, both by reducing the alveolar surface tension and by exerting immunomodulatory effects.
In a previous study by the same team, favorable effects were seen in intubated patients; however, the aim of this study was to evaluate the effect of exogenous nebulized surfactant in the pre-intubation stages of the disease.
Detailed description
Exogenous surfactant in neonates with clinical pulmonary distress syndrome has demonstrated pulmonary improvement; the latter being one of the most important applications of exogenous surfactant. In adults with underlying lung disease, especially Adult Respiratory Distress Syndrome (ARDS), there are controversial findings regarding the efficacy of surfactant.
However, in a previous study, it was shown that surfactant in COVID-19 patients with pulmonary intubation improved pulmonary function and gas exchange and also, reduced patient mortality.
However, none of the other repurposed drugs in COVID-19 have yet been able to prove significant effects in the treatment of patients; based on a recent study on more than 11000 COVID-19 patients (i.e. the SOLIDARITY study).
Due to the significant worldwide challnege with COVID-19, many efforts have been made in this regard, but the definitive cure has not yet been obtained, and therefore, efforts are being made to find an effective method to treat the disease and improve patients' symptoms; parallel to the efforts to increase the vaccination coverage.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nebulized Surfactant | Experimental | Drug: exogenous surfactantThe patients in this group will receive exogenous surfactant using nebulizer mask as soon as they are admitted in the hospital (ward or emergency department) with a diagnosis of COVID-19; in addition they will receive standard care based on the national guidelines |
| Standard Care | No intervention | –The patients in this group will receive standard care based on the national guidelines as soon as they are admitted in the hospital (ward or emergency department) with a diagnosis of COVID-19 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age over 18 years
- definitive proof of COVID-19 infection by polymerase chain reaction (PCR) within 48 hours of hospital admission
- COVID-19 related Moderate ARDS following Berlin criteria definition with PaO2/FiO2 < 200 requiring what condition?
- Signed and dated informed consent form (ICF) by the subject or caregivers
Key exclusion criteria (12 listed)
- known or high suspicion of pre-existing heart failure, unstable angina
- presence of severe shock with hemodynamic instability despite escalating vasopressors
- Severe, underlying pulmonary infection or severe pulmonary disease except for COVID-19 (COPD, pulmonary fibrosis, lung cancer, bacterial pneumonia, etc.)
- Diagnosis of pulmonary hemorrhage
- Pregnancy or lactation
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 |
|---|---|---|
| exogenous surfactantNebulized Surfactant would be administered by face mask which has a nebulizer | Drug | Nebulized Surfactant |
Primary outcome
rate of tracheal intubation
Time frame: through study completion, an average of 1 year
the frequency of patients who will be intubated due to deteriorated pulmonary function
rate of ICU admission
Time frame: through study completion, an average of 1 year
the frequency of patients who will be admitted to intensive care unit due to deteriorated pulmonary function
lowest oxygen saturation
Time frame: through study completion, an average of 1 year
lowest number reading in the pulse oxymetry in one of the fingers or toes
2 secondary outcomes
30 days mortality
Time frame: the first 30 days after hospital admission
90 days mortality
Time frame: the first 90 days after hospital admission
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2021.
- BackgroundGhahremani M, Fathi M, Massoudi N, Tavana S, Fani K, Nooraee N, Malekpour Alamdari N, Besharat S, Naja Abrandabadi A, Pirsalehi A, Khabiri Khatiri MA, Amini Pouya M, Rajaei S, Dabbagh A. Exogenous Surfactant Versus Placebo in the Treatment of Moderate and Severe ARDS in COVID19: The Pilot Study of a Clinical Trial. DOI: https://doi.org/10.21203/rs.3.rs-136365/v1. Preprint.
- Results publication: PubMed 32199073Takian A, Raoofi A, Kazempour-Ardebili S. COVID-19 battle during the toughest sanctions against Iran. Lancet. 2020 Mar 28;395(10229):1035-1036. doi: 10.1016/S0140-6736(20)30668-1. Epub 2020 Mar 18. No abstract available.
- Results publication: PubMed 32087216Zhang Y, Xu J, Li H, Cao B. A Novel Coronavirus (COVID-19) Outbreak: A Call for Action. Chest. 2020 Apr;157(4):e99-e101. doi: 10.1016/j.chest.2020.02.014. Epub 2020 Feb 19. No abstract available.
- Results publication: PubMed 32692208Yue H, Bai X, Wang J, Yu Q, Liu W, Pu J, Wang X, Hu J, Xu D, Li X, Kang N, Li L, Lu W, Feng T, Ding L, Li X, Qi X; Gansu Provincial Medical Treatment Expert Group of COVID-19. Clinical characteristics of coronavirus disease 2019 in Gansu province, China. Ann Palliat Med. 2020 Jul;9(4):1404-1412. doi: 10.21037/apm-20-887. Epub 2020 Jul 13.
- Results publication: PubMed 33734299INSPIRATION Investigators; Sadeghipour P, Talasaz AH, Rashidi F, Sharif-Kashani B, Beigmohammadi MT, Farrokhpour M, Sezavar SH, Payandemehr P, Dabbagh A, Moghadam KG, Jamalkhani S, Khalili H, Yadollahzadeh M, Riahi T, Rezaeifar P, Tahamtan O, Matin S, Abedini A, Lookzadeh S, Rahmani H, Zoghi E, Mohammadi K, Sadeghipour P, Abri H, Tabrizi S, Mousavian SM, Shahmirzaei S, Bakhshandeh H, Amin A, Rafiee F, Baghizadeh E, Mohebbi B, Parhizgar SE, Aliannejad R, Eslami V, Kashefizadeh A, Kakavand H, Hosseini SH, Shafaghi S, Ghazi SF, Najafi A, Jimenez D, Gupta A, Madhavan MV, Sethi SS, Parikh SA, Monreal M, Hadavand N, Hajighasemi A, Maleki M, Sadeghian S, Piazza G, Kirtane AJ, Van Tassell BW, Dobesh PP, Stone GW, Lip GYH, Krumholz HM, Goldhaber SZ, Bikdeli B. Effect of Intermediate-Dose vs Standard-Dose Prophylactic Anticoagulation on Thrombotic Events, Extracorporeal Membrane Oxygenation Treatment, or Mortality Among Patients With COVID-19 Admitted to the Intensive Care Unit: The INSPIRATION Randomized Clinical Trial. JAMA. 2021 Apr 27;325(16):1620-1630. doi: 10.1001/jama.2021.4152.
- Results publication: PubMed 33176850Dabbagh A, Rajaei S, Ghahremani M, Fathi M, Massoudi N, Tavana S, Fani K, Nooraee N, Malekpour Alamdari N, Besharat S, Najafi Abrandabadi A, Pirsalehi A, Khabiri Khatiri MA. The effect of surfactant on clinical outcome of patients with COVID-19 under mechanical ventilation: A structured summary of a study protocol for a randomised controlled trial. Trials. 2020 Nov 11;21(1):919. doi: 10.1186/s13063-020-04815-z.
- Results publication: PubMed 32908083Alamdari NM, Afaghi S, Rahimi FS, Tarki FE, Tavana S, Zali A, Fathi M, Besharat S, Bagheri L, Pourmotahari F, Irvani SSN, Dabbagh A, Mousavi SA. Mortality Risk Factors among Hospitalized COVID-19 Patients in a Major Referral Center in Iran. Tohoku J Exp Med. 2020 Sep;252(1):73-84. doi: 10.1620/tjem.252.73.
- Results publication: PubMed 32085846Xu Z, Shi L, Wang Y, Zhang J, Huang L, Zhang C, Liu S, Zhao P, Liu H, Zhu L, Tai Y, Bai C, Gao T, Song J, Xia P, Dong J, Zhao J, Wang FS. Pathological findings of COVID-19 associated with acute respiratory distress syndrome. Lancet Respir Med. 2020 Apr;8(4):420-422. doi: 10.1016/S2213-2600(20)30076-X. Epub 2020 Feb 18. No abstract available.
- Individual participant dataSharing planned: Undecided. to be determined
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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.
Afshin Zarghi, PhD study chair
Deputy of Research and Technology, Shahid Beheshti University of Medical Sciences
Questions about this trial
What is this clinical trial studying?
A study testing exogenous surfactant in people with COVID-19 and Respiratory Distress Syndrome, run by Shahid Beheshti University of Medical Sciences.
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 4 inclusion and 12 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 19 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Ali Dabbagh, MD (+989121972368, alidabbagh@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rate of tracheal intubation (time frame: through study completion, an average of 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04847375, which also lists 8 linked publications.
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 19 Apr 2021.