NCT04376593

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for early_phase_1 covid19

Timeline
Completed

Started May 2020

Longer than P75 for early_phase_1 covid19

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2020

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

May 3, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 6, 2020

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 23, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 23, 2026

Completed
Last Updated

March 10, 2026

Status Verified

December 1, 2025

Enrollment Period

5.8 years

First QC Date

May 3, 2020

Last Update Submit

March 9, 2026

Conditions

COVID-19SARS-CoV-2 Infection

Keywords

COVID-19; SARS-CoV2 infection

Outcome Measures

Primary Outcomes (3)

  • Administration of 18F-αvβ6-BP

    Completion of administration of 18F-αvβ6-BP in SARC CoV2 patients

    baseline

  • Administration of 18F-αvβ6-BP

    Completion of administration of 18F-αvβ6-BP in SARC CoV2 patients

    3 months

  • Administration of 18F-αvβ6-BP

    Completion of administration of 18F-αvβ6-BP in SARC CoV2 patients

    6 months

Secondary Outcomes (3)

  • Determine whether 18F-αvβ6-BP demonstrates accumulation in lung damage

    baseline

  • Determine whether 18F-αvβ6-BP demonstrates accumulation in lung damage

    3 months

  • Determine whether 18F-αvβ6-BP demonstrates accumulation in lung damage

    6 months

Other Outcomes (3)

  • Determine whether 18F-αvβ6-BP accumulation in lung correlates to lung damage as indicated on CT.

    baseline

  • Determine whether 18F-αvβ6-BP accumulation in lung correlates to lung damage as indicated on CT.

    3 months

  • Determine whether 18F-αvβ6-BP accumulation in lung correlates to lung damage as indicated on CT.

    6 months

Study Arms (1)

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.

Drug: 18F-αvβ6-BP

Interventions

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).

18F-αvβ6-BP

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California Davis

Sacramento, California, 95817, United States

Location

Related Links

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 3, 2020

First Posted

May 6, 2020

Study Start

May 1, 2020

Primary Completion

February 23, 2026

Study Completion

February 23, 2026

Last Updated

March 10, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)