Surfactant Protein Genetic Variants in COVID-19 Infection

Sponsor

Milton S. Hershey Medical Center (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04650191

Collaborator

(none)

300

Enrollment

Location

Anticipated Duration (Months)

10.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Surfactant protein plays important role in innate immunity against respiratory viral infections. However, investigators have shown that the surfactant protein polymorphisms are associated with severity of various pulmonary diseases such as respiratory syncytial virus (RSV), tuberculosis, pediatric acute lung injury. COVID-19 virus gains entry through the respiratory system and responsible for death due to acute respiratory failure. There is a considerable heterogeneity in presentation of COVID-19 infection from asymptomatic patients to severe infection requiring intensive care and some may die. Considering reports of COVID-19 related deaths/severe disease in the same family, it is possible that genetics play an important role in severity of COVID-19 infection. Investigators propose to study the association of surfactant proteins in COVID-19 patients. Key Objectives: a) Characterize genetic markers within the surfactant protein genes in COVID-19 positive patients, b) To determine if there is a correlation between certain genetic markers and the severity of COVID-19 infection which may be used as a prognostic marker, c) To correlate genetic markers with immune studies.

Condition or Disease	Intervention/Treatment	Phase
Coronavirus Infection	Other: Identification of genetic variants

Study Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

300 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Surfactant Protein Genetic Variants in COVID-19 Infection

Actual Study Start Date :

Mar 1, 2020

Actual Primary Completion Date :

Jun 30, 2021

Anticipated Study Completion Date :

Jun 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Mild COVID-19 infection Patients with confirmed COVID-19 infection who remained asymptomatic and/or never hospitalized.	Other: Identification of genetic variants DNA will be extracted from whole blood from study subjects
Moderate COVID-19 infection Patients with confirmed COVID-19 infection who got admitted in general ward in the hospital.	Other: Identification of genetic variants DNA will be extracted from whole blood from study subjects
Severe COVID-19 infection Patients with confirmed COVID-19 infection who got admitted in intensive care unit and/or did not survive.	Other: Identification of genetic variants DNA will be extracted from whole blood from study subjects

Arm

Intervention/Treatment

Mild COVID-19 infection

Patients with confirmed COVID-19 infection who remained asymptomatic and/or never hospitalized.

Other: Identification of genetic variants

DNA will be extracted from whole blood from study subjects

Moderate COVID-19 infection

Patients with confirmed COVID-19 infection who got admitted in general ward in the hospital.

Other: Identification of genetic variants

DNA will be extracted from whole blood from study subjects

Severe COVID-19 infection

Patients with confirmed COVID-19 infection who got admitted in intensive care unit and/or did not survive.

Other: Identification of genetic variants

DNA will be extracted from whole blood from study subjects

Outcome Measures

Primary Outcome Measures

Correlation of surfactant protein genetic variants with severity of COVID-19 infection [12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Day to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

The major inclusion criteria is a confirmed diagnosis of COVID-19 infection performed on nasopharyngeal secretions by enzyme immunoassay or culture in patients.

Exclusion Criteria:

Patients unable to sign informed consent will be excluded.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Milton S. Hershey Medical center	Hershey	Pennsylvania	United States	17033

Sponsors and Collaborators

Milton S. Hershey Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Chintan Gandhi, Assistant Professor, Milton S. Hershey Medical Center

ClinicalTrials.gov Identifier:

NCT04650191

Other Study ID Numbers:

15456

First Posted:

Dec 2, 2020

Last Update Posted:

Sep 16, 2021

Last Verified:

Sep 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Infections

Communicable Diseases

Coronavirus Infections

Study Results

No Results Posted as of Sep 16, 2021