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

• Status: Not yet recruiting
• Trial end date: 2021-09-20
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shahid Beheshti University of Medical Sciences
• Treatments: Pulmonary Surfactants

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