COVID-19 DiseaseNCT04587323
VEGF and sFlt-1 Levels in the Pathogenesis and Severity of COVID-19 Disease
An observational study of COVID-19 Disease, run by University of Alabama at Birmingham at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19 Disease
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 22 May 2020to 6 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have available specimens in the UAB CCTS Biorepository for COVID-19 patients. (IRB-300005127: COVID-19 Enterprise Biorepository.)
Who may be able to join
- Positive test for COVID-19 (SARS-CoV-2 infection)
- >=18 years
- Blood (plasma) specimen(s) available in the CCTS biorepository
Who cannot join
- <18 years
- Lack of blood specimen
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35294
About this study
Official title: COVID-19 RELATED SUBMISSION: 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.
Read the 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
- Keywords
- COVID-19, SARS-CoV-2 viral infection, VEGF and sFlt-1 levels
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 7-14 days after symptom onset
VEGF-A
Plasma samples will be analyzed to measure VEGF-A
Measured: 7-14 days after symptom onset
VEGF-C
Plasma samples will be analyzed to measure VEGF-C
Measured: 7-14 days after symptom onset
VEGF-D
Plasma samples will be analyzed to measure VEGF-D
Measured: 7-14 days after symptom onset
Tie-2
Plasma samples will be analyzed to measure Tie-2
Measured: 7-14 days after symptom onset
Flt-1
Plasma samples will be analyzed to measure Flt-1
Measured: 7-14 days after symptom onset
PlGF
Plasma samples will be analyzed to measure PlGF
Measured: 7-14 days after symptom onset
FGF
Plasma samples will be analyzed to measure FGF
Measured: 7-14 days after symptom onset
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start22 May 2020
- Primary completion6 Oct 2025
- Study completion6 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 DiseaseStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dylan R. Addis, MD, University of Alabama at Birmingham
- Investigators
- Dylan Addis, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04587323
- Sponsor's protocol ID
- IRB-300005378
- Other IDs
- UAB
- Status last verified
- Oct 2025
- First submitted
- 22 Sep 2020
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID-19 RELATED SUBMISSION: VEGF and sFlt-1 Levels in the Pathogenesis and Severity of COVID-19 Disease
- ClinicalTrials.gov ID
- NCT04587323
- Acronym / sponsor ID
- IRB-300005378
- Conditions
- COVID-19 Disease
- Keywords
- COVID-19, SARS-CoV-2 viral infection, VEGF and sFlt-1 levels
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 22 May 2020 (actual)
- Primary completion
- 6 Oct 2025 (actual)
- Study completion
- 6 Oct 2025 (actual)
- First posted
- 14 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have available specimens in the UAB CCTS Biorepository for COVID-19 patients. (IRB-300005127: COVID-19 Enterprise Biorepository.)
Key inclusion criteria (3 listed)
- Positive test for COVID-19 (SARS-CoV-2 infection)
- >=18 years
- Blood (plasma) specimen(s) available in the CCTS biorepository
Key exclusion criteria (2 listed)
- <18 years
- Lack of blood specimen
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
VEGF-A
Time frame: 7-14 days after symptom onset
Plasma samples will be analyzed to measure VEGF-A
VEGF-C
Time frame: 7-14 days after symptom onset
Plasma samples will be analyzed to measure VEGF-C
VEGF-D
Time frame: 7-14 days after symptom onset
Plasma samples will be analyzed to measure VEGF-D
Tie-2
Time frame: 7-14 days after symptom onset
Plasma samples will be analyzed to measure Tie-2
Flt-1
Time frame: 7-14 days after symptom onset
Plasma samples will be analyzed to measure Flt-1
PlGF
Time frame: 7-14 days after symptom onset
Plasma samples will be analyzed to measure PlGF
FGF
Time frame: 7-14 days after symptom onset
Plasma samples will be analyzed to measure FGF
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dylan Addis, MD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 Disease, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Laboratory Assays (time frame: 7-14 days after symptom onset). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.