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

NCT ID: NCT04409184

Last Updated: 2020-08-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2020-08-14

Study Completion Date

2020-08-14

Brief Summary

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The study was not opened.

Detailed Description

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Conditions

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COVID Sars-CoV2

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Convalescent subjects

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

No interventions assigned to this group

Healthy controls

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

Patients who have previously been diagnosed with COVID-19 but are now asymptomatic \>14 days and a matched number of healthy controls:

1. 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performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
2. 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
3. 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.
4. Age: Greater or equal to 18 years of age. a. Subject must be able to provide voluntary written consent

Exclusion Criteria

1. 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.
2. 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.
3. Patients receiving ongoing medical symptomatic treatment or prophylaxis treatment related to COVID-19 due to SARS-CoV-2
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Versiti

OTHER

Sponsor Role collaborator

Medical College of Wisconsin

OTHER

Sponsor Role lead

Responsible Party

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Weiguo Cui

Associate Professor, Microbiology & Immunology

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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PRO00037957

Identifier Type: -

Identifier Source: org_study_id

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