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Exogenous Surfactant Through Nebulizer Mask on Clinical Outcomes in Covid-19 Patients (CovidSurf)

Primary Purpose

COVID-19, Respiratory Distress Syndrome, Surface-Active Agents

Status

Unknown status

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

exogenous surfactant

About this trial

This is an interventional treatment trial for COVID-19 focused on measuring Covid-19, exogenous surfactant, Adult Respiratory Distress Syndrome, nebulizer

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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
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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Nebulized Surfactant

Standard Care

Arm Description

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

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

Outcomes

Primary Outcome Measures

rate of tracheal intubation

the frequency of patients who will be intubated due to deteriorated pulmonary function

rate of ICU admission

the frequency of patients who will be admitted to intensive care unit due to deteriorated pulmonary function

lowest oxygen saturation

lowest number reading in the pulse oxymetry in one of the fingers or toes

Secondary Outcome Measures

30 days mortality

the mortality rate during the first 30 days after the first day of hospital admission

90 days mortality

the mortality rate during the first 90 days after the first day of hospital admission

Full Information

NCT ID

NCT04847375

First Posted

April 10, 2021

Last Updated

April 14, 2021

Sponsor

Shahid Beheshti University of Medical Sciences

1. Study Identification

Unique Protocol Identification Number

NCT04847375

Brief Title

Exogenous Surfactant Through Nebulizer Mask on Clinical Outcomes in Covid-19 Patients

Acronym

CovidSurf

Official Title

Evaluation of the Effect of Exogenous Surfactant Through Nebulizer Mask on Clinical Outcomes in Covid-19 Patients

Study Type

Interventional

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Unknown status

Study Start Date

April 20, 2021 (Anticipated)

Primary Completion Date

July 20, 2021 (Anticipated)

Study Completion Date

September 20, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Shahid Beheshti University of Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

COVID-19, Respiratory Distress Syndrome, Surface-Active Agents

Keywords

Covid-19, exogenous surfactant, Adult Respiratory Distress Syndrome, nebulizer

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Masking Description

The outcome assessor would be blind regarding the study groups

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Nebulized Surfactant

Arm Type

Experimental

Arm Description

Arm Title

Standard Care

Arm Type

No Intervention

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

exogenous surfactant

Intervention Description

Nebulized Surfactant would be administered by face mask which has a nebulizer

Primary Outcome Measure Information:

Title

rate of tracheal intubation

Description

the frequency of patients who will be intubated due to deteriorated pulmonary function

Time Frame

through study completion, an average of 1 year

Title

rate of ICU admission

Description

the frequency of patients who will be admitted to intensive care unit due to deteriorated pulmonary function

Time Frame

through study completion, an average of 1 year

Title

lowest oxygen saturation

Description

lowest number reading in the pulse oxymetry in one of the fingers or toes

Time Frame

through study completion, an average of 1 year

Secondary Outcome Measure Information:

Title

30 days mortality

Description

the mortality rate during the first 30 days after the first day of hospital admission

Time Frame

the first 30 days after hospital admission

Title

90 days mortality

Description

the mortality rate during the first 90 days after the first day of hospital admission

Time Frame

the first 90 days after hospital admission

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ali Dabbagh, MD

Phone

+989121972368

alidabbagh@yahoo.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Afshin Zarghi, PhD

Organizational Affiliation

Deputy of Research and Technology, Shahid Beheshti University of Medical Sciences

Official's Role

Study Chair

12. IPD Sharing Statement

Plan to Share IPD

Undecided

IPD Sharing Plan Description

to be determined

Citations:

Citation

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.

Results Reference

background

PubMed Identifier

32199073

Citation

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. Erratum In: Lancet. 2020 Apr 18;395(10232):1258.

Results Reference

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PubMed Identifier

32087216

Citation

Zhang 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 Reference

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PubMed Identifier

32692208

Citation

Yue 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 Reference

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PubMed Identifier

33734299

Citation

INSPIRATION 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 Reference

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PubMed Identifier

33176850

Citation

Dabbagh 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 Reference

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PubMed Identifier

32908083

Citation

Alamdari 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 Reference

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PubMed Identifier

32085846

Citation

Xu 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. Erratum In: Lancet Respir Med. 2020 Feb 25;:

Results Reference

result

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Exogenous Surfactant Through Nebulizer Mask on Clinical Outcomes in Covid-19 Patients

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