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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
Sponsor:
Information provided by (Responsible Party):
Ali Dabbagh, Shahid Beheshti University of Medical Sciences

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.


Condition or disease Intervention/treatment Phase
COVID-19 Respiratory Distress Syndrome Surface-Active Agents Drug: exogenous surfactant Not Applicable

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 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: The outcome assessor would be blind regarding the study groups
Primary Purpose: Treatment
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


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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

  2. 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

  3. 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


Secondary Outcome Measures :
  1. 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

  2. 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



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
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Contact: Ali Dabbagh, MD +989121972368 alidabbagh@yahoo.com

Sponsors and Collaborators
Shahid Beheshti University of Medical Sciences
Investigators
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Study Chair: Afshin Zarghi, PhD Deputy of Research and Technology, Shahid Beheshti University of Medical Sciences
Publications of Results:
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.

Other Publications:
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.

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Responsible Party: Ali Dabbagh, Clinical Professor, Shahid Beheshti University of Medical Sciences
ClinicalTrials.gov Identifier: NCT04847375    
Other Study ID Numbers: 27348
First Posted: April 19, 2021    Key Record Dates
Last Update Posted: April 19, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: to be determined

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Ali Dabbagh, Shahid Beheshti University of Medical Sciences:
Covid-19
exogenous surfactant
Adult Respiratory Distress Syndrome
nebulizer
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Pulmonary Surfactants
Respiratory System Agents