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

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

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04409184

Enrollment

Registered

2020-06-01

Start date

2020-08-14

Completion date

2020-08-14

Last updated

2020-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID, Sars-CoV2

Brief summary

The study was not opened.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care. 2.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

Design outcomes

Primary

Measure	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.

Outcome results