Status:

UNKNOWN

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

Lead Sponsor:

Shahid Beheshti University of Medical Sciences

Conditions:

COVID-19

Respiratory Distress Syndrome

Eligibility:

All Genders

18-80 years

Phase:

NA

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 ...

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 a...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

April 20 2021

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

September 20 2021

Estimated Enrollment :

60 Patients enrolled

Trial Details

Trial ID

NCT04847375

Start Date

April 20 2021

End Date

September 20 2021

Last Update

April 19 2021

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