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

Withdrawn

• Conditions: Sars-CoV2; COVID

• Registration Number: NCT04409184
• Lead Sponsor: Medical College of Wisconsin

Brief Summary

The study was not opened.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-05-28
• Study First Submitted QC: 2020-05-28
• Study First Posted: 2020-06-01
• Status Verified: 2020-08
• Study Start: 2020-08-14
• Primary Completion: 2020-08-14
• Study Completion: 2020-08-14
• Last Update Submitted: 2020-08-14
• Last Update Posted: 2020-08-18

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.