Whole Blood Collection From Individuals in the Convalesce... | NCT04409184

Studies
Whole Blood Collection From Individuals in the Convalescent Phase of SARS-CoV-2 Infection

NCT04409184

Sponsor

Medical College of Wisconsin

Status

Withdrawn

Last Update Posted

Aug 18, 2020Actual

Enrollment

0Actual

Phase

Not provided

Conditions

COVID
Sars-CoV2

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2020

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study was not opened.

Expanded Access Info

Start Date

Aug 14, 2020Actual

Primary Completion Date

Aug 14, 2020Actual

Completion Date

Aug 14, 2020Actual

First Submitted Date

May 28, 2020

First Submission Date that Met QC Criteria

May 28, 2020

First Posted Date

Jun 1, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 14, 2020

Last Update Posted Date

Aug 18, 2020Actual

Name	Class
Versiti Blood Health	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Measure	Description	Time Frame
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.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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:
1. Experimental Population: Subject has had positive SARS-CoV-2 verified by clinical laboratory OR
2. 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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Label	Type	Description	Intervention Names
Convalescent subjects		Convalescent, now asymptomatic, subjects with documented prior COVID-19 due to SARS-CoV-2 infection
Healthy controls