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

April 14, 2021 updated by: Ali Dabbagh, Shahid Beheshti University of Medical Sciences

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
through study completion, an average of 1 year
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
through study completion, an average of 1 year
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
through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
the first 30 days after 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
the first 90 days after hospital admission

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shahid Beheshti University of Medical Sciences

Investigators

  • Study Chair: Afshin Zarghi, PhD, Deputy of Research and Technology, Shahid Beheshti University of Medical Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 20, 2021

Primary Completion (Anticipated)

July 20, 2021

Study Completion (Anticipated)

September 20, 2021

Study Registration Dates

First Submitted

April 10, 2021

First Submitted That Met QC Criteria

April 14, 2021

First Posted (Actual)

April 19, 2021

Study Record Updates

Last Update Posted (Actual)

April 19, 2021

Last Update Submitted That Met QC Criteria

April 14, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 27348

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

to be determined

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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