VEGF and sFlt-1 Levels in the Pathogenesis and Severity of COVID-19 Disease

COVID-19 Disease Clinical Trial

Official title:

COVID-19 RELATED SUBMISSION: VEGF and sFlt-1 Levels in the Pathogenesis and Severity of COVID-19 Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04587323
• Other study ID #: IRB-300005378
• Status: Recruiting
• Start date: May 22, 2020
• Est. completion date: January 20, 2025

Study information

• Verified date: March 2024
• Source: University of Alabama at Birmingham
• Contact: Dylan Addis, MD
• Phone: 919-812-5107
• Email: dylanaddis[@]uabmc.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To assess blood levels of vasoactive mediators that may regulate pulmonary endothelial permeability and contribute to multi-organ injury in patients with COVID-19 disease and to correlate the levels of these mediators with disease outcomes such as ICU admission, length of ventilatory support, respiratory failure, kidney failure, heart failure, and death.

Description:

When patients are sick with other lung infections (pneumonias) caused by viruses or bacteria there are changes in a pathway that regulates the "leakiness" the tiny airspaces inside the lungs. Even bigger changes in this pathway are seen when patients develop severe breathing difficulties (acute respiratory distress syndrome) similar to what is seen in patients who get really sick with COVID-19 disease.

There are important changes in this pathway that occur in patients who have preexisting cardiovascular (heart) disease who do not have lung infections. The investigator will evaluate these levels in patients with COVID-19 because the investigator believes that this baseline difference in pathway regulation may be one reason patients with heart disease who contract COVID-19 get sicker than patients without heart or vascular disease.

The investigator will also assess the levels of components of this pathway in patients who are less sick with those who became sick enough to require a tube to help them breathe because this is important to determine if COVID-19 lung disease has a similar effect on this pathway as other lung infections like flu and bacterial pneumonias.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 20, 2025
• Est. primary completion date: December 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Positive test for COVID-19 (SARS-CoV-2 infection)

• >=18 years

• Blood (plasma) specimen(s) available in the CCTS biorepository

Exclusion Criteria:

• <18 years

• Lack of blood specimen

Related Conditions & MeSH terms

• COVID-19
• COVID-19 Disease

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Laboratory Assays	The primary outcome measure is the ratio of soluble fms-like tyrosine kinase receptor-1 (sFlt-1) to vascular endothelial growth factor (VEGF) which will be obtained using an immunoassay on blood samples. The specimens will be analyzed using enzyme-linked immunosorbent assay and reported as a ratio	7-14 days after symptom onset
Primary	VEGF-A	Plasma samples will be analyzed to measure VEGF-A	7-14 days after symptom onset
Primary	VEGF-C	Plasma samples will be analyzed to measure VEGF-C	7-14 days after symptom onset
Primary	VEGF-D	Plasma samples will be analyzed to measure VEGF-D	7-14 days after symptom onset
Primary	Tie-2	Plasma samples will be analyzed to measure Tie-2	7-14 days after symptom onset
Primary	Flt-1	Plasma samples will be analyzed to measure Flt-1	7-14 days after symptom onset
Primary	PlGF	Plasma samples will be analyzed to measure PlGF	7-14 days after symptom onset
Primary	FGF	Plasma samples will be analyzed to measure FGF	7-14 days after symptom onset