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

Sponsor
University of Alabama at Birmingham (Other)
Overall Status
Recruiting
CT.gov ID
NCT04587323
Collaborator
(none)
100
Enrollment
1
Location
35.9
Anticipated Duration (Months)
2.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    COVID-19 RELATED SUBMISSION: VEGF and sFlt-1 Levels in the Pathogenesis and Severity of COVID-19 Disease
    Actual Study Start Date :
    May 22, 2020
    Anticipated Primary Completion Date :
    Mar 20, 2023
    Anticipated Study Completion Date :
    May 20, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    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).

    Outcome Measures

    Primary Outcome Measures

    1. Laboratory Assays [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 [7-14 days after symptom onset]

      Plasma samples will be analyzed to measure VEGF-A

    3. VEGF-C [7-14 days after symptom onset]

      Plasma samples will be analyzed to measure VEGF-C

    4. VEGF-D [7-14 days after symptom onset]

      Plasma samples will be analyzed to measure VEGF-D

    5. Tie-2 [7-14 days after symptom onset]

      Plasma samples will be analyzed to measure Tie-2

    6. Flt-1 [7-14 days after symptom onset]

      Plasma samples will be analyzed to measure Flt-1

    7. PlGF [7-14 days after symptom onset]

      Plasma samples will be analyzed to measure PlGF

    8. FGF [7-14 days after symptom onset]

      Plasma samples will be analyzed to measure FGF

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Alabama at Birmingham Birmingham Alabama United States 35294

    Sponsors and Collaborators

    • University of Alabama at Birmingham

    Investigators

    • Principal Investigator: Dylan Addis, MD, University of Alabama at Birmingham

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dylan R. Addis, MD, Principal Investigator, University of Alabama at Birmingham
    ClinicalTrials.gov Identifier:
    NCT04587323
    Other Study ID Numbers:
    • IRB-300005378
    First Posted:
    Oct 14, 2020
    Last Update Posted:
    Nov 23, 2021
    Last Verified:
    Nov 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Dylan R. Addis, MD, Principal Investigator, University of Alabama at Birmingham
    COVID-19
    SARS-CoV-2 viral infection
    VEGF and sFlt-1 levels
    Additional relevant MeSH terms:
    COVID-19

    Study Results

    No Results Posted as of Nov 23, 2021