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

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Drug: exogenous surfactant


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nebulized Surfactant<br>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<br>* Nebulized Surfactant would be administered by face mask which has a nebulizer<br>|
| No Intervention: Standard Care<br>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 the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30 days mortality | the mortality rate during the first 30 days after the first day of hospital admission | 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 | the first 90 days after hospital admission | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Covid-19, exogenous surfactant, Adult Respiratory Distress Syndrome, nebulizer