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

NCT04847375 | Unknown

• 1 other identifier: 27348
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (3)

• rate of tracheal intubation

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

  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

  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

  through study completion, an average of 1 year

Secondary Outcomes (2)

• 30 days mortality

  the first 30 days after hospital admission

• 90 days mortality

  the first 90 days after hospital admission

Study Arms (2)

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

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

Interventions

exogenous surfactant DRUG

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

Nebulized Surfactant

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shahid Beheshti University of Medical Sciences: lead

Related Publications (8)

• 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.

  BACKGROUND

• 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.

  PMID: 32199073 RESULT

• 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.

  PMID: 32087216 RESULT

• 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.

  PMID: 32692208 RESULT

• 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.

  PMID: 33734299 RESULT

• 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.

  PMID: 33176850 RESULT

• 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.

  PMID: 32908083 RESULT

• 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.

  PMID: 32085846 RESULT

MeSH Terms

Conditions

COVID-19; Respiratory Distress Syndrome

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; Respiration Disorders

Study Officials

• Afshin Zarghi, PhD

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

  STUDY CHAIR

Central Study Contacts

Ali Dabbagh, MD

CONTACT

+989121972368; alidabbagh@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome assessor would be blind regarding the study groups
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: April 10, 2021
• First Posted: April 19, 2021
• Study Start: April 20, 2021
• Primary Completion: July 20, 2021
• Study Completion: September 20, 2021
• Last Updated: April 19, 2021

Record last verified: 2021-04