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

NCT04587323 | Completed

• 2 other identifiers: IRB-300005378UAB
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19 Disease

Keywords

COVID-19; SARS-CoV-2 viral infection; VEGF and sFlt-1 levels

Outcome Measures

Primary Outcomes (8)

• 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

• VEGF-A

  Plasma samples will be analyzed to measure VEGF-A

  7-14 days after symptom onset

• VEGF-C

  Plasma samples will be analyzed to measure VEGF-C

  7-14 days after symptom onset

• VEGF-D

  Plasma samples will be analyzed to measure VEGF-D

  7-14 days after symptom onset

• Tie-2

  Plasma samples will be analyzed to measure Tie-2

  7-14 days after symptom onset

• Flt-1

  Plasma samples will be analyzed to measure Flt-1

  7-14 days after symptom onset

• PlGF

  Plasma samples will be analyzed to measure PlGF

  7-14 days after symptom onset

• FGF

  Plasma samples will be analyzed to measure FGF

  7-14 days after symptom onset

Study Arms (4)

Group 1:

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

Group 2:

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

Group 3:

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

Group 4:

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

Eligibility Criteria

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

Study Population

Patients who have available specimens in the UAB CCTS Biorepository for COVID-19 patients. (IRB-300005127: COVID-19 Enterprise Biorepository.)

You may qualify if:

• Positive test for COVID-19 (SARS-CoV-2 infection)
• \>=18 years
• Blood (plasma) specimen(s) available in the CCTS biorepository

You may not qualify if:

• \<18 years
• Lack of blood specimen

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

We will identify patients with COVID-19 disease within the CCTS Biorepository with a blood (plasma) sample from within 7-14 days of symptom onset

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Dylan Addis, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 22, 2020
• First Posted: October 14, 2020
• Study Start: May 22, 2020
• Primary Completion: October 6, 2025
• Study Completion: October 6, 2025
• Last Updated: February 27, 2026

Record last verified: 2025-10

Locations

US (1)