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OpenTrials
Completed

NCT Number: NCT04587323

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

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.

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Key information

Conditions

COVID-19 Disease COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Laboratory Assays

    Time frame: 7-14 days after symptom onset

    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

  2. VEGF-A

    Time frame: 7-14 days after symptom onset

    Plasma samples will be analyzed to measure VEGF-A

  3. VEGF-C

    Time frame: 7-14 days after symptom onset

    Plasma samples will be analyzed to measure VEGF-C

  4. VEGF-D

    Time frame: 7-14 days after symptom onset

    Plasma samples will be analyzed to measure VEGF-D

  5. Tie-2

    Time frame: 7-14 days after symptom onset

    Plasma samples will be analyzed to measure Tie-2

  6. Flt-1

    Time frame: 7-14 days after symptom onset

    Plasma samples will be analyzed to measure Flt-1

  7. PlGF

    Time frame: 7-14 days after symptom onset

    Plasma samples will be analyzed to measure PlGF

  8. FGF

    Time frame: 7-14 days after symptom onset

    Plasma samples will be analyzed to measure FGF

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Oct 14, 2020
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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