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

COVID Clinical Trial

Official title:

Evaluation of Whole Blood Samples From Coronavirus Disease 2019 (COVID-19) Convalescent Patients to Study Immune Response and Severity of Disease Predictors

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04409184
• Other study ID #: PRO00037957
• Status: Withdrawn
• Start date: August 14, 2020
• Est. completion date: August 14, 2020

Study information

• Verified date: August 2020
• Source: Medical College of Wisconsin
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The study was not opened.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 14, 2020
• Est. primary completion date: August 14, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.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

Related Conditions & MeSH terms

• COVID
• Sars-CoV2

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Medical College of Wisconsin	Versiti

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.