Surfactant Protein Genetic Variants in COVID-19 Infection

Coronavirus Infection Clinical Trial

Official title:

Surfactant Protein Genetic Variants in COVID-19 Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04650191
• Other study ID #: 15456
• Status: Completed
• Start date: March 1, 2020
• Est. completion date: June 30, 2022

Study information

• Verified date: September 2022
• Source: Milton S. Hershey Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Day to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Coronavirus Infection
• Coronavirus Infections
• Infections

Intervention

Other:
• Identification of genetic variants
DNA will be extracted from whole blood from study subjects

Locations

Country	Name	City	State
United States	Milton S. Hershey Medical center	Hershey	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation of surfactant protein genetic variants with severity of COVID-19 infection		12 months