Yale COVID-19 Recovery Study

NCT04895189 | Completed

• 2 other identifiers: 20000304232U01FD005938-03
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 1

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 condition in which people have persistent or emerging symptoms months after an initial SARS-CoV-2 infection, (the virus that causes coronavirus disease 2019, or COVID-19. Specifically, the purpose is to enroll participants suffering from moderate-to-severe PASC prior to vaccination and to measure participants' immune and symptom profiles both before and after vaccination. This study is primarily descriptive.

Conditions

Covid19 Sequelae

Outcome Measures

Primary Outcomes (2)

• Surveys 2-4 Effect of Vaccination

  The primary outcome for the study is whether people's overall health condition improves, does not change, or worsens after receiving the COVID-19 vaccine. This outcome will be measured with the question in Surveys 2-4: "Would you say that your overall health, as compared to your health before the vaccine, is worse, better, or the same?" The number of participants within each group will be reported.

  The measure will be reported both longitudinally, over the 3 months following the participant post-vaccination (reporting the result at 2 weeks, 6 weeks, and 12 weeks post-vaccination), and as a cross-sectional result at the end of the study (week 12).

• Immune Assay Findings

  For each group of participants by overall health condition change, immune response trends that were found through saliva-based or blood-based analyses will be reported. Trends found in the immune cells, antibodies, and viral loads of participants for whom symptoms either improved, worsened, or did not change after vaccination will be reported.

  The measure will be reported both longitudinally, over the 3 months following the participant post-vaccination (reporting the result at 2 weeks, 6 weeks, and 12 weeks post-vaccination), and as a cross-sectional result at the end of the study (week 12).

Secondary Outcomes (4)

• Surveys 1-4 Overall Change in Symptoms

  The measure will be reported both longitudinally, over the 3 months following the participant post-vaccination (reporting the result at 2 weeks, 6 weeks, and 12 weeks post-vaccination), and as a cross-sectional result at the end of the study (week 12).

• Surveys 2-4 Change in Symptom Severity

  The measure will be reported both longitudinally, over the 3 months following the participant post-vaccination (reporting the result at 2 weeks, 6 weeks, and 12 weeks post-vaccination), and as a cross-sectional result at the end of the study (week 12).

• Surveys 2-4 Change in Symptom Frequency

  The measure will be reported both longitudinally, over the 3 months following the participant post-vaccination (reporting the result at 2 weeks, 6 weeks, and 12 weeks post-vaccination), and as a cross-sectional result at the end of the study (week 12).

• Surveys 2-4 Change in Symptom Duration

  The measure will be reported both longitudinally, over the 3 months following the participant post-vaccination (reporting the result at 2 weeks, 6 weeks, and 12 weeks post-vaccination), and as a cross-sectional result at the end of the study (week 12).

Interventions

No intervention OTHER

There is no intervention for this observational study. The investigators are observing the changes in participants before and after the participants receive the COVID-19 vaccine, which participants will receive outside of the study.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study participants will include adults aged 18 and over who either have been diagnosed with COVID-19, hospitalized due to COVID-19, or who have tested positive for SARS-CoV-2 more than 2 months prior to joining the study (PCR, antigen, or a positive T-test or antibody test at any point), and who have proof of the diagnosis, hospitalization, or positive test; who intend to receive the vaccine for SARS-CoV-2, but who have not yet received any doses of the vaccine; and who self report having persistent moderate-to-severe symptoms or disability.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead
• Food and Drug Administration (FDA): collaborator

Study Sites (1)

Yale New Haven Hospital

New Haven, Connecticut, 06510, United States

Location

Related Publications (1)

• Grady CB, Bhattacharjee B, Silva J, Jaycox J, Lee LW, Silva Monteiro V, Sawano M, Massey D, Caraballo C, Gehlhausen JR, Tabachnikova A, Mao T, Lucas C, Pena-Hernandez MA, Xu L, Tzeng TJ, Takahashi T, Herrin J, Guthe DB, Akrami A, Assaf G, Davis H, Harris K, McCorkell L, Schulz WL, Griffin D, Wei H, Ring AM, Guan L, Dela Cruz C, Krumholz HM, Iwasaki A. Impact of COVID-19 vaccination on symptoms and immune phenotypes in vaccine-naive individuals with Long COVID. Commun Med (Lond). 2025 May 9;5(1):163. doi: 10.1038/s43856-025-00829-3.

  PMID: 40346201 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

The biospecimen collection will require 45cc of blood and a saliva sample (5 mL) to be given 3 times by each participant. The blood sample will immediately undergo mild agitation and remain stored under controlled temperature. Saliva samples will be self-collected by the participant, who will receive instructions upon arriving at the draw site.

Study Officials

• Harlan Krumholz, MD, SM

  Director, Center for Outcomes Research and Evaluation (CORE)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2021
• First Posted: May 20, 2021
• Study Start: May 3, 2021
• Primary Completion: June 9, 2023
• Study Completion: May 9, 2025
• Last Updated: May 29, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: The data will become available once data collection is complete, in approximately May of 2022. The data will be deleted after 10 years.

Locations

US (1)