COVID-19Early Phase 1NCT04376593
PET/CT Imaging in COVID-19 Patients
A Early Phase 1 study testing 18F-αvβ6-BP in people with COVID-19 and SARS-CoV-2 Infection, run by University of California, Davis at 1 site in United States.
Trial summary
This is a PET/CT study using the 18F-αvβ6-binding-peptide.The goal of this study is to evaluate this peptide in patients after infection with SARS CoV2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19, SARS-CoV-2 Infection
- What is being tested?
- 18F-αvβ6-BP
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2020to 23 Feb 2026
- Phase
- Early Phase 1
- 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
Who may be able to join
- Men and women age ≥ 18 yrs
- Diagnosed with SARS CoV2
- Must have 2 sequential COVID negative tests prior to each scan
- Must have no previous lung disease prior to SARS CoV2 infection
- Lung image (Xray or CT) taken during infectious/ diagnosis period
- Will sign the IRB-approved consent form
- Able to remain motionless for up to 30-60 minutes per scan.
Who cannot join
- Life expectancy <3 mo
- Women who are pregnant or breast-feeding
- Patients who cannot undergo PET/CT scanning because of weight limits(>350lbs)
- Lack of availability for follow-up assessments
- Re-infection with SARS CoV2 between scan sessions
- Other active infectious respiratory illness
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California Davis
Sacramento, California, 95817
About this study
Official title: 18F-αvβ6-binding-peptide PET/CT in Patients Post SARS CoV2 Infection
This is a PET/CT study using the 18F-αvβ6-binding-peptide.The goal of this study is to evaluate this peptide in patients after infection with SARS CoV2.
Read the detailed description
The goal of the study is to to acquire 18F-αvβ6-BP PET/CT images in patients diagnosed with SARS CoV2 and to demonstrate the ability of 18F-αvβ6-BP to detect lung damage.
- Conditions
- COVID-19, SARS-CoV-2 Infection
- Being tested
- 18F-αvβ6-BP
- Keywords
- COVID-19; SARS-CoV2 infection
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-αvβ6-BPDrug
Subjects will be injected once per imaging session (a maximum of 3 imaging sessions) with up to 10 mCi (±20%) of 18F-αvβ6-BP as a rapid intravenous bolus (within 30 secs).
| Study group | Role | What they receive |
|---|---|---|
| 18F-αvβ6-BP | Experimental | Following a 10 mCi (±20%) intravenous injection (IV) of 18F-αvβ6-BP, PET/CT images will be acquired at 60 minutes. Baseline blood samples will be drawn and banked. Vital sign (VS) measurements (heart rate, respiratory rate, blood pressure and temperature) monitored throughout. Region-of-interest analysis (ROI) will be performed in the lung. Each participant will undergo up to 3 18F- αvβ6-BP PET/CT scans over a 6-month timeframe. Receives: Drug: 18F-αvβ6-BP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Administration of 18F-αvβ6-BP
Completion of administration of 18F-αvβ6-BP in SARC CoV2 patients
Measured: baseline
Administration of 18F-αvβ6-BP
Completion of administration of 18F-αvβ6-BP in SARC CoV2 patients
Measured: 3 months
Administration of 18F-αvβ6-BP
Completion of administration of 18F-αvβ6-BP in SARC CoV2 patients
Measured: 6 months
Secondary outcomes (3)
Determine whether 18F-αvβ6-BP demonstrates accumulation in lung damage
Uptake of 18F-αvβ6-BP in lung damage will be measured by PET
Measured: baseline
Determine whether 18F-αvβ6-BP demonstrates accumulation in lung damage
Uptake of 18F-αvβ6-BP in lung damage will be measured by PET
Measured: 3 months
Determine whether 18F-αvβ6-BP demonstrates accumulation in lung damage
Uptake of 18F-αvβ6-BP in lung damage will be measured by PET
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2020
- Study start1 May 2020
- Primary completion23 Feb 2026
- Study completion23 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by University of California, DavisThe 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
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04376593
- Sponsor's protocol ID
- 1592298
- Status last verified
- Dec 2025
- First submitted
- 3 May 2020
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 18F-αvβ6-binding-peptide PET/CT in Patients Post SARS CoV2 Infection
- ClinicalTrials.gov ID
- NCT04376593
- Acronym / sponsor ID
- 1592298
- Conditions
- COVID-19, SARS-CoV-2 Infection
- Keywords
- COVID-19; SARS-CoV2 infection
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- 23 Feb 2026 (actual)
- Study completion
- 23 Feb 2026 (actual)
- First posted
- 6 May 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.
This is a PET/CT study using the 18F-αvβ6-binding-peptide.The goal of this study is to evaluate this peptide in patients after infection with SARS CoV2.
Detailed description
The goal of the study is to to acquire 18F-αvβ6-BP PET/CT images in patients diagnosed with SARS CoV2 and to demonstrate the ability of 18F-αvβ6-BP to detect lung damage.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 18F-αvβ6-BP | Experimental | Drug: 18F-αvβ6-BPFollowing a 10 mCi (±20%) intravenous injection (IV) of 18F-αvβ6-BP, PET/CT images will be acquired at 60 minutes. Baseline blood samples will be drawn and banked. Vital sign (VS) measurements (heart rate, respiratory rate, blood pressure and temperature) monitored throughout. Region-of-interest analysis (ROI) will be performed in the lung. Each participant will undergo up to 3 18F- αvβ6-BP PET/CT scans over a 6-month timeframe. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Men and women age ≥ 18 yrs
- Diagnosed with SARS CoV2
- Must have 2 sequential COVID negative tests prior to each scan
- Must have no previous lung disease prior to SARS CoV2 infection
- Lung image (Xray or CT) taken during infectious/ diagnosis period
Key exclusion criteria (6 listed)
- Life expectancy <3 mo
- Women who are pregnant or breast-feeding
- Patients who cannot undergo PET/CT scanning because of weight limits(>350lbs)
- Lack of availability for follow-up assessments
- Re-infection with SARS CoV2 between scan sessions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 18F-αvβ6-BPSubjects will be injected once per imaging session (a maximum of 3 imaging sessions) with up to 10 mCi (±20%) of 18F-αvβ6-BP as a rapid intravenous bolus (within 30 secs). | Drug | 18F-αvβ6-BP |
Primary outcome
Administration of 18F-αvβ6-BP
Time frame: baseline
Completion of administration of 18F-αvβ6-BP in SARC CoV2 patients
Administration of 18F-αvβ6-BP
Time frame: 3 months
Completion of administration of 18F-αvβ6-BP in SARC CoV2 patients
Administration of 18F-αvβ6-BP
Time frame: 6 months
Completion of administration of 18F-αvβ6-BP in SARC CoV2 patients
3 secondary outcomes
Determine whether 18F-αvβ6-BP demonstrates accumulation in lung damage
Time frame: baseline
Determine whether 18F-αvβ6-BP demonstrates accumulation in lung damage
Time frame: 3 months
Determine whether 18F-αvβ6-BP demonstrates accumulation in lung damage
Time frame: 6 months
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 10 Mar 2026.
- Learn more or sign up for the study here!Link provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for COVID-19
Not yet recruitingPhase 1
Evaluating AVM0703 for Treatment of COVID-19 or Influenza-mediated ARDS
ARDS, Covid19
Active, not recruitingObservational study
Vaccine Responses to SARS-CoV-2 and Other Emerging Infectious Diseases
COVID-19, Vaccination
RecruitingPhase 4
Comparative Immunogenicity of Respiratory Virus Vaccines (CIRV2) Study
COVID -19, COVID - 19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
RecruitingObservational study
Clinical Outcomes and Pharmacotherapy Effectiveness in the VA Health Care System (COPE-VA)
COVID-19, SARS-CoV-2 Infection, RSV
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing 18F-αvβ6-BP in people with COVID-19 and SARS-CoV-2 Infection, run by University of California, Davis 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 7 inclusion and 6 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 10 Mar 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Administration of 18F-αvβ6-BP (time frame: baseline). The study lists 3 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 10 Mar 2026.