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

NCT ID: NCT04587323

Last Updated: 2025-05-30

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-05-22
• Study Completion Date: 2026-12-20

Brief 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.

Detailed 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.

Conditions

COVID-19 Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Group 1:

Group 1: COVID-19 + inpatients who did not require mechanical ventilation (25 patients);

No interventions assigned to this group

Group 2:

Group 2: COVID-19 + inpatients who required mechanical ventilation (25 patients).

No interventions assigned to this group

Group 3:

Group 3: COVID-19 + inpatients with no preexisting cardiovascular disease (25 patients)

No interventions assigned to this group

Group 4:

Group 4: COVID-19 + inpatients with preexisting cardiovascular disease (25 patients).

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Dylan R. Addis, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dylan Addis, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Dylan Addis, MD

Role: CONTACT

dylanaddis@uabmc.edu

919-812-5107

Shanna H Graves

Role: CONTACT

shannagraves@uabmc.edu

205-975-2845

Facility Contacts

Dylan Addis, MD

Role: primary

dylanaddis@uabmc.edu

919-812-5107

Shanna H Graves

Role: backup

shannagraves@uabmc.edu

205-975-2845

Other Identifiers

UAB

Identifier Type: OTHER

Identifier Source: secondary_id

IRB-300005378

Identifier Type: -

Identifier Source: org_study_id