Surfactant Protein Genetic Variants in COVID-19 Infection

NCT04650191 | Completed

• 1 other identifier: 15456
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronavirus Infection

Outcome Measures

Primary Outcomes (1)

• Correlation of surfactant protein genetic variants with severity of COVID-19 infection

  12 months

Study Arms (3)

Mild COVID-19 infection

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

Other: Identification of genetic variants

Moderate COVID-19 infection

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

Other: Identification of genetic variants

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

Interventions

Identification of genetic variants OTHER

DNA will be extracted from whole blood from study subjects

Mild COVID-19 infection; Moderate COVID-19 infection; Severe COVID-19 infection

Eligibility Criteria

• Age: 1 Day - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Subjects with positive COVID-19 infection will be enrolled regardless of age and sex after obtaining informed consent.

You may not qualify if:

• Patients unable to sign informed consent will be excluded.

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead

Study Sites (1)

Milton S. Hershey Medical center

Hershey, Pennsylvania, 17033, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

DNA will be stored for the future studies.

MeSH Terms

Conditions

Coronavirus Infections

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 30, 2020
• First Posted: December 2, 2020
• Study Start: March 1, 2020
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: September 15, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)