NCT04841707

Brief Summary

The primary objective is to measure the change between COVID-19 patients and normal subjects; the secondary objective is to measure the change in COVID-19 patients between baseline and 4-month follow up.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
13

participants targeted

Target at below P25 for not_applicable covid19

Timeline
Completed

Started May 2021

Typical duration for not_applicable 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

First Submitted

Initial submission to the registry

March 31, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 12, 2021

Completed
28 days until next milestone

Study Start

First participant enrolled

May 10, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 6, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 6, 2022

Completed
Last Updated

March 10, 2026

Status Verified

December 1, 2022

Enrollment Period

1.2 years

First QC Date

March 31, 2021

Last Update Submit

March 9, 2026

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

  • BAB permeability assessed

    Evaluating if there is a change in BAB permeability assessed by lung FDG K1 for patients with COVID 19

    1 imaging visit up to 60 minutes

Secondary Outcomes (1)

  • 4 month follow-up PET/CT scan

    1 imaging visit up to 60 minutes

Study Arms (1)

COVID-19 patients

EXPERIMENTAL
Device: uEXPLORER/mCT

Interventions

uEXPLORER/mCTDEVICE

Each participant will undergo two 18F-FDG PET/CT scans, one at baseline and one at 4- month (+/- 2 weeks) follow-up.

COVID-19 patients

Eligibility Criteria

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

You may qualify if:

  • COVID-19 positive patients will have a previous positive COVID-19 test and radiographic findings, and/or a positive SARS-CoV-2 antibody test and be in early recovery.
  • First PET/CT visit needs to be within 8 weeks of COVID-19 diagnosis.
  • Ability to understand and willingness to sign an informed consent form.
  • Ability to adhere to the study visit schedule and other protocol requirements.
  • All persons ≥18 years of age.

You may not qualify if:

  • Pregnant or lactating women.
  • Any condition that would prohibit the understanding or rendering of informed consent.
  • Unable to lie supine for 1-hour imaging with PET.
  • Prisoners.
  • Any comorbidity that, in the opinion of the investigator, could compromise protocol objectives.

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 Officials

  • Guobao Wang, PhD

    University of California, Davis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2021

First Posted

April 12, 2021

Study Start

May 10, 2021

Primary Completion

July 6, 2022

Study Completion

July 6, 2022

Last Updated

March 10, 2026

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)