The general purpose of the study is to determine the change in immune responses in peoplewith Post-Acute Sequelae of SARS-CoV-2 Infection (PASC) after vaccination. PASC is adisabling, heterogeneous condition in which people have persistent or emerging symptomsmonths after an initial SARS-CoV-2 infection, (the virus that causes coronavirus disease2019, or COVID-19. Specifically, the purpose is to enroll participants suffering frommoderate-to-severe PASC prior to vaccination and to measure participants' immune andsymptom profiles both before and after vaccination. This study is primarily descriptive.
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 primarily to describe the heterogeneity in symptoms and
immune profile among people with PASC, and once participants have been vaccinated, to
determine changes in clinical and immune responses to vaccination and whether there is an
association.
Broadly, the study will include 4 surveys to monitor participants' symptom profile and
experience with COVID-19 as well as 3 separate biospecimen collection appointments. The
surveys and study enrollment will be conducted through REDCap at Yale, a platform that is
designed to securely collect survey data from people in a user-friendly design setting.
The biospecimen collection will occur at 2 Yale New Haven Health blood draw sites. The
biospecimen collection will occur as follows: the first will occur as soon as a
participant is enrolled, the second will occur 6 weeks after the participant receives the
first dose of a COVID-19 vaccine, and the third will occur 12 weeks after the participant
receives the first dose of a COVID-19 vaccine. Participants will be asked to provide
45ccs of blood and a saliva sample (up to 5 mL) for each biospecimen collection.
Participants will be able to give a blood sample within a 2-week window (e.g. the
collection may be within 5-7 weeks after the participant's first COVID-19 vaccine dose).
The survey collection will occur as follows: the first will occur as soon as the
participant is enrolled, the second will occur 2 weeks after the participant receives the
first dose of a COVID-19 vaccine, the third will occur 6 weeks after the participant
receives the first dose of a COVID-19 vaccine, and the fourth will occur 12 weeks after
the participant receives the first dose of COVID-19 vaccine. Survey links and reminders
will be sent by the Yale research team through REDCap at Yale (via text and/or email) and
specimen collection scheduling will be coordinated between the Yale research team and the
Yale New Haven Health draw sites.
The study recruitment efforts will be coordinated with YCCI, according to YCCI standards.
The investigators will also distribute a study flyer at local Long Covid health clinics
and on social media, including Twitter and Facebook. In addition to recruitment efforts
at Yale, the investigators' patient partners, Survivor Corps, will be publicizing the
study by sharing the study information and eligibility requirements on social media
including Facebook and Twitter. Survivor Corps's recruitment efforts will not be
coordinated by the Yale research team. There will be a study landing page where potential
participants can find information about the study and the study link.
Potential participants will be provided a link for the study enrollment as well as an
email address (covidrecovery@yale.edu) to reach out for more information about the study.
The study enrollment process will take place on REDCap at Yale and by phone. Participants
will complete a brief screening questionnaire to determine study eligibility and to
provide an email address and/or phone number. Study coordinators will then reach out, by
email to schedule a phone consultation, or directly by phone, as is the participant's
preference. During the phone consultation, a study coordinator will read a script
designed to inform the participant of the study design and risks to ensure that the
participant understands the study prior to consent. The participant will also be asked if
the participant has any questions for the study coordinator. Once the phone consultation
is complete, the study coordinator will email the participant a link to the e-consent,
which will be a REDCap form. Once the participant consents to the study, which will
require an e-signature, a study coordinator will sign a REDCap form to acknowledge that
the e-consent is complete. An email will automatically be sent to the participant
containing the (REDCap) link for the first survey and information as to how to provide
the first biospecimen sample. The research team will also contact the participant within
the next 2-3 days by phone to provide information regarding the timing and location for
biospecimen collection and to answer any questions the participant has.
Participants will provide blood and saliva samples 3 times at any of the study's 2 Yale
New Haven Health blood draw sites. While all specimen collection will occur in
Connecticut at these sites, people who are not currently patients within the Yale New
Haven Health system will still be eligible to participate in the study, so long as the
participant is willing and able to travel to one of the blood draw sites 3 times. The
Yale study consent will include consenting to providing blood and saliva samples 3 times
at a Yale New Haven Health site.
This research will foster a community spirit with participants, producing a collaboration
based on relationships, not merely transactions. The Survivor Corps group has joined this
effort and will ensure that the study includes the participant perspective and abide by
the study's principles. Survivor Corps is an independent group of people who experienced
long-term effects of SARS-CoV-2 infection and seek to generate knowledge about people
with prolonged recoveries. The Patient-Led Research Collaborative has also joined this
effort to provide a PASC participant perspective on the study's participant-facing
communication and surveys. Patient-Led Research is also an independent group of people
who experienced long-term effects of SARS-CoV-2 infection and seek to generate knowledge
about people with prolonged recoveries.
The study will utilize REDCap at Yale to screen for eligibility, conduct e-consent, and
to collect survey information. The data will reside within the secure platform and will
be transferred to Yale via a secure file transfer service. The data will then reside on
secure servers at Yale.
Other: No intervention
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.
Inclusion Criteria:
1. Fluent in English or Spanish
2. Age 18 years and over
3. 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
4. Self-report moderate to severe symptoms or disability due to PASC
5. Self-report planning to receive a vaccine against SARS-CoV-2
6. Self-report has not yet received any doses of a vaccine against SARS-CoV-2
Exclusion Criteria:
1. Unable to provide informed consent
2. 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).
3. Does not have access to a hand-held device or computer that would allow for digital
participation in the study
4. Do not have and do not want to set up an email address
5. Individuals who are prisoners
Yale New Haven Hospital
New Haven, Connecticut, United States
Harlan Krumholz, MD, SM, Principal Investigator
Director, Center for Outcomes Research and Evaluation (CORE)