Status:
COMPLETED
Yale COVID-19 Recovery Study
Lead Sponsor:
Yale University
Collaborating Sponsors:
Food and Drug Administration (FDA)
Conditions:
Covid19 Sequelae
Eligibility:
All Genders
18+ years
Brief Summary
The general purpose of the study is to determine the change in immune responses in people with Post-Acute Sequelae of SARS-CoV-2 Infection (PASC) after vaccination. PASC is a disabling, heterogeneous ...
Detailed Description
The investigators are conducting an observational study within Connecticut of adults who have moderate-to-severe PASC and who are planning to receive a vaccine against SARS-CoV-2. The study seeks prim...
Eligibility Criteria
Inclusion
- Fluent in English or Spanish
- Age 18 years and over
- Test positive for SARS-CoV-2 (defined as a patient who reports receiving any screening or diagnostic test used to detect the presence of SARS-CoV-2 including any FDA-approved or authorized molecular or antigen-based assay) at least 2 months prior to the start of this study OR test positive for antibodies to SARS-CoV-2 at any point OR receive a positive T-test at any point OR receive a clinical diagnoses of COVID-19 at any point OR was hospitalized due to COVID-19 at any point
- Self-report moderate to severe symptoms or disability due to PASC
- Self-report planning to receive a vaccine against SARS-CoV-2
- Self-report has not yet received any doses of a vaccine against SARS-CoV-2
Exclusion
- Unable to provide informed consent
- Unable to provide 3 blood and saliva samples at one of the 2 participating Yale New Haven Health blood draw sites on a Monday or Wednesday morning (before 12 pm).
- Does not have access to a hand-held device or computer that would allow for digital participation in the study
- Do not have and do not want to set up an email address
- Individuals who are prisoners
Key Trial Info
Start Date :
May 3 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 9 2025
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT04895189
Start Date
May 3 2021
End Date
May 9 2025
Last Update
May 29 2025
Active Locations (1)
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1
Yale New Haven Hospital
New Haven, Connecticut, United States, 06510