Exogenous Surfactant Through Nebulizer Mask on Clinical Outcomes in Covid-19 Patients (CovidSurf)
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|ClinicalTrials.gov Identifier: NCT04847375|
Recruitment Status : Not yet recruiting
First Posted : April 19, 2021
Last Update Posted : April 19, 2021
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.
|Condition or disease||Intervention/treatment||Phase|
|COVID-19 Respiratory Distress Syndrome Surface-Active Agents||Drug: exogenous surfactant||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||The outcome assessor would be blind regarding the study groups|
|Official Title:||Evaluation of the Effect of Exogenous Surfactant Through Nebulizer Mask on Clinical Outcomes in Covid-19 Patients|
|Estimated Study Start Date :||April 20, 2021|
|Estimated Primary Completion Date :||July 20, 2021|
|Estimated Study Completion Date :||September 20, 2021|
Experimental: Nebulized Surfactant
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
Nebulized Surfactant would be administered by face mask which has a nebulizer
No Intervention: Standard Care
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
- rate of tracheal intubation [ Time Frame: through study completion, an average of 1 year ]the frequency of patients who will be intubated due to deteriorated pulmonary function
- rate of ICU admission [ Time Frame: through study completion, an average of 1 year ]the frequency of patients who will be admitted to intensive care unit due to deteriorated pulmonary function
- lowest oxygen saturation [ Time Frame: through study completion, an average of 1 year ]lowest number reading in the pulse oxymetry in one of the fingers or toes
- 30 days mortality [ Time Frame: the first 30 days after hospital admission ]the mortality rate during the first 30 days after the first day of hospital admission
- 90 days mortality [ Time Frame: the first 90 days after hospital admission ]the mortality rate during the first 90 days after the first day of hospital admission
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04847375
|Contact: Ali Dabbagh, MDfirstname.lastname@example.org|
|Study Chair:||Afshin Zarghi, PhD||Deputy of Research and Technology, Shahid Beheshti University of Medical Sciences|