- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04409184
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
Study Overview
Study Type
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.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:
- Experimental Population: Subject has had positive SARS-CoV-2 verified by clinical laboratory OR
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
Healthy controls
|
Convalescent subjects
Convalescent, now asymptomatic, subjects with documented prior COVID-19 due to SARS-CoV-2 infection
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Characterization of specific T cell responses in peripheral blood isolated from patients that have been exposed to SARS-CoV-2.
Time Frame: Up to 1 year post infection.
|
Up to 1 year post infection.
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- PRO00037957
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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