NCT04409184

Brief Summary

The study was not opened.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2020

Status
withdrawn

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

May 28, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 1, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

August 14, 2020

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 14, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 14, 2020

Completed
Last Updated

August 18, 2020

Status Verified

August 1, 2020

Enrollment Period

Same day

First QC Date

May 28, 2020

Last Update Submit

August 14, 2020

Conditions

COVIDSars-CoV2

Outcome Measures

Primary Outcomes (1)

  • Characterization of specific T cell responses in peripheral blood isolated from patients that have been exposed to SARS-CoV-2.

    Up to 1 year post infection.

Study Arms (2)

Convalescent subjects

Convalescent, now asymptomatic, subjects with documented prior COVID-19 due to SARS-CoV-2 infection

Healthy controls

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Individuals cared for at Froedtert Hospital, Milwaukee, Wisconsin who meet the inclusion and exclusion criteria as outlined.

You may qualify if:

  • Patients who have previously been diagnosed with COVID-19 but are now asymptomatic \>14 days and a matched number of healthy controls:
  • Consent: Subject able to provide voluntary written consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
  • SARS-CoV-2 Testing Status:
  • Experimental Population: Subject has had positive SARS-CoV-2 verified by clinical laboratory OR
  • Control Population: Subject without testing or negative SARS-CoV-2 testing
  • Complete resolution and current absence of clinical symptoms Symptoms Defined as: Fever, Dry cough, Fatigue, Difficulty breathing, Sore throat, Diarrhea, Rhinorrhea (runny nose), or new aches/pains.
  • Age: Greater or equal to 18 years of age. a. Subject must be able to provide voluntary written consent

You may not qualify if:

  • Ongoing symptoms of COVID19 due to SARS-CoV-2 infection
  • a. Symptoms Defined as: Fever, Dry cough, Fatigue, Difficulty breathing, Sore throat, Diarrhea, Rhinorrhea (runny nose), or new aches/pains.
  • Ongoing symptoms not due or not known to be due to SARS-CoV-2 infection
  • a. Symptoms Defined as: Fever, Dry cough, Fatigue, Difficulty breathing, Sore throat, Diarrhea, Rhinorrhea (runny nose), or new aches/pains.
  • Patients receiving ongoing medical symptomatic treatment or prophylaxis treatment related to COVID-19 due to SARS-CoV-2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Microbiology & Immunology

Study Record Dates

First Submitted

May 28, 2020

First Posted

June 1, 2020

Study Start

August 14, 2020

Primary Completion

August 14, 2020

Study Completion

August 14, 2020

Last Updated

August 18, 2020

Record last verified: 2020-08