Surfactant Protein Genetic Variants in COVID-19 Infection

Completed

• Conditions: Coronavirus Infection
• Interventions: Other: Identification of genetic variants

• Registration Number: NCT04650191
• Lead Sponsor: Milton S. Hershey Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-03-01
• Study First Submitted: 2020-11-30
• Study First Submitted QC: 2020-12-01
• Study First Posted: 2020-12-02
• Primary Completion: 2022-06-30
• Study Completion: 2022-06-30
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-14
• Last Update Posted: 2022-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Moderate COVID-19 infection	Identification of genetic variants	Patients with confirmed COVID-19 infection who got admitted in general ward in the hospital.
Severe COVID-19 infection	Identification of genetic variants	Patients with confirmed COVID-19 infection who got admitted in intensive care unit and/or did not survive.
Mild COVID-19 infection	Identification of genetic variants	Patients with confirmed COVID-19 infection who remained asymptomatic and/or never hospitalized.

Primary Outcome Measures

Name	Time	Method
Correlation of surfactant protein genetic variants with severity of COVID-19 infection	12 months

Trial Locations

Locations (1)

Milton S. Hershey Medical center; 🇺🇸 Hershey, Pennsylvania, United States