Question 1

What is the purpose of the expansion study?

Accepted Answer

The expansion study is designed to understand how our responses to immune and inflammatory stressors, such as infections and vaccines, can influence our health and well-being over time.   People who might appear similar in overall health status can often respond very differently to the same stress triggers – and these differences can shed light on future health trajectories.   We plan to serially measure antibodies and other factors that can represent health trajectories that diverge over time. We are taking this approach to uncover scientific clues and make new discoveries that may guide us on how to maximize recovery from stress and improve longer-term health for all.

Question 2

How is the expansion study different from the original study?

Accepted Answer

When our team founded the original CORALE study in March 2020, we hoped the pandemic might last a year or less. We focused our studies on illness susceptibility and resistance, and we built resources to support serial assessments, including repeat antibody testing, for up to 2 years. Recognizing the persistent effects of the pandemic, our team is now committed to studying how individuals and communities can recover from the pandemic and maintain health resilience over the longer term. We have now built resources that can support more frequent assessments, including repeat antibody testing, for up to 5 years or longer as needed. For this reason, this expansion study will minimize any added time commitment for original CORALE study participants while allowing the option for more frequent assessments, including antibody testing, for a longer period of time.

Question 3

Are there any other hospitals or locations that are sites for this study?

Accepted Answer

Due to operational logistics, the expansion study is currently only open for enrollment for employees and patients who are directly affiliated with the Cedars-Sinai Medical Center and associated medical networks. A limited number of enrolled participants who have moved out of the Los Angeles area may continue participation through remote health surveys and remote biosampling collection kits.

Question 4

How can I access any data or publications associated with the study?

Accepted Answer

Our recent scientific reports are listed here and will be updated as new information is generated.

Question 5

How can I contact you for additional information?

Accepted Answer

For additional questions about the study, you may email contact@embarc-study.org.

Question 6

What is the time commitment for participating in the study?

Accepted Answer

All participation and time commitment is completely voluntary. This study offers free blood draws and health surveys up to once a month for up to 5 years or longer. Each appointment for a blood draw (e.g. for antibody testing) takes up to 15 minutes to complete. Each electronic health survey takes up to 5 to 15 minutes to complete. Given the longitudinal nature of this study, our study team will contact you periodically to coordinate on-site appointments and provide reminders regarding electronic surveys. We may also keep in touch to check in on your health status following a serious illness or hospitalization. We may also contact you about the option for additional research assessments or studies, all of which will also be voluntary.

Question 7

Do I get anything out of the study?

Accepted Answer

This study will provide to participants free testing and results for Qualitative IgG antibodies against SARS-CoV-2 nucleocapsid and Quantitative IgG antibodies against SARS-CoV-2 spike protein. We ask that participants who engage in antibody testing with returned results are willing to obtain a COVID-19 test (ideally a PCR nasopharyngeal swab) if returned results suggest recent infection or exposure to COVID.  As part of the study, additional research diagnostics will be performed for which results will be used for research only. The information learned from this study may help many others in the future. Participants are not be paid for taking part in this research study.

Question 8

What is the purpose of the health surveys?

Accepted Answer

The surveys are designed to collect information on sociodemographic, clinical, lifestyle, environmental, molecular, and other factors that can influence future health status. The surveys also collect information regarding changes in symptoms, medical history, medications, or exposures that can help us to understand how individuals respond from immunological stressors, such as infections and vaccines, over the short-term as well as over the long-term.

Question 9

Who will have access to my information?

Accepted Answer

Organizations that may access your information for quality assurance and data analysis, only as needed, include: certified and approved study investigators and research staff, accrediting agencies (agencies that grant official certifications or educational institutions), organizations that sponsor the study (access is restricted to de-identified data only), safety monitors, and government and regulatory groups including the Food and Drug Administration (FDA) and Office for Human Research Protections (OHRP), and the Institutional Review Board (IRB), which reviews protocols to protect people taking part in studies.

Question 10

Are there any risks involved in this study?

Accepted Answer

All research studies involve some risks. Risks or discomforts from this study are considered minimal. With respect to the survey portions of the study, you may feel uncomfortable about answering some questions and you can choose to skip answering any questions. With respect to biospecimen collection (e.g. blood draw) procedures, you may also experience some temporary discomfort from a finger prick or venipuncture. You can always choose to skip any biospecimen collection procedure now or in the future.

Question 11

Are there any reasons my participation may be stopped?

Accepted Answer

Participation in the study may be discontinued if funding for the study is reduced or discontinued, if the study is discontinued or suspended for any reason, if you do not follow the study procedures, and or if it is in your best interest to discontinue participation.

Question 12

Is there any cost to participating?

Accepted Answer

There is no cost to participating in this study. There will be no charge to you or your insurance company for your participation in this research study.

Question 13

Who is eligible to enroll into this study?

Accepted Answer

This current phase of the expansion study is open to all Cedars Sinai employees or patients who are age 5 years or older and have an active Cedars Sinai medical record number. All eligible individuals are invited to enroll at this link. Family members of employees must also be age 5 years or older and have an active Cedars-Sinai medical record number to be eligible for the study. Enrollment of individuals under age 5 years is being considered for a future phase of the study. Interested individuals who are not currently affiliated with Cedars-Sinai can send us their name along with the name of the hospital or health system where they usually receive medical care. This information can be provided by entering information at this link or by emailing us at join@embarc-study.org along with the subject line: "future study". Individuals who are not currently affiliated with Cedars-Sinai may be considered for a future phase of the study.

Question 14

How do I enroll into the study?

Accepted Answer

You may enroll in the study by clicking on this link to the electronic consent form and intake survey. After completing the consent and intake survey, all participants are invited to schedule an appointment for initial blood draw at this link.

Question 15

If I did not obtain a pre-vaccine or pre-booster blood draw, am I still eligible to enroll?"

Accepted Answer

Any adult Cedars-Sinai employee or patient is eligible to enroll into the study at any time, regardless of vaccination status or timing.

Question 16

What is the schedule for blood draws for antibody testing?

Accepted Answer

We are offering up to monthly blood draws for all participants.

Question 17

How do I schedule an appointment for a blood draw?

Accepted Answer

You can select an appointment time and location by clicking this link. If your preferred dates and times are full, you may elect to visit a blood draw station or contact us to find out if we may be able to accommodate a same-day walk-in appointment. Due to the high volume of visits, priority will be given to participants who have a pre-scheduled appointment.

Question 18

How do I know which "visit type" to schedule?"

Accepted Answer

If this will be your very first blood draw for either the EMBARC or CORALE study, please select "My first blood draw" from the drop-down menu on the scheduling site.    If this will be a blood draw that is close in timing to a vaccine dose, please select "Blood draw before a vaccine dose: within 30 days" or "Blood draw after a vaccine dose: 14-21 days" from the drop-down menu on the scheduling site (even if this might be your first blood draw).   If this will be a follow-up blood draw of any other type, not close in timing to a vaccine dose, please select "Follow-up blood draw" from the drop-down menu on the scheduling site.    All blood draw visits are optional.

Question 19

How can I change my appointment time?

Accepted Answer

Each appointment confirmation email will provide a link to “Change/Cancel Appointment” that allows you to change your appointment date or time, as needed. You may also email any additional scheduling queries to us at contact@embarc-study.org.

Question 20

Where is the research clinic located?

Accepted Answer

For Cedars-Sinai employees and patients, the main site for clinical research visits including blood draw appointments is the Human Physiology Laboratory in the Steven Spielberg Building. Directions to this site are here.   Due to operational logistics, we are currently able to conduct lab draws for employees and patients only at the main Cedars-Sinai Medical Center campus. If you live or work at a distance from the main campus, we are happy to accommodate any date and time that you may select for a blood draw appointment at the main campus that fits into your busy schedule. While some participants may be offered up to monthly laboratory testing, all blood draw visits are optional and you may contribute visits as your schedule allows. In addition, if you have any lab draws conducted with an affiliated Cedars-Sinai laboratory that sends samples to the central Cedars-Sinai campus for processing, we can try to locate the remnant samples in our central lab on your behalf and prepare these samples for antibody testing and other assays. If you would like to pursue this option, please let us know via email at least 3-5 days prior to your planned blood draw at the satellite site, so that our team can plan accordingly.

Question 21

What are hours of operation for the research clinic and blood draw appointments?

Accepted Answer

We are open for research clinic visits and blood draw appointments Monday through Thursday, 7:30 am to 4:00 pm, and Friday 7:30 am to 12:00 pm. Please note that we close earlier on Fridays to accommodate for same day biospecimen processing. The clinic site is also closed on holidays and for staff training days, as indicated in the online scheduling calendar.

Question 22

Do you accept walk-in appointments?

Accepted Answer

We do accept a limited number of walk-in blood draw appointments for study participants. Due to the high volume of visits, priority will be given to participants who have a pre-scheduled appointment which can be made at this link.

Question 23

Do you validate for parking at the research clinic site?

Accepted Answer

Although we do not validate for parking, there is easily accessible parking in front of the clinical research site building where the first hour of parking is free. Directions and details can be found here.

Question 24

Can I change my preferred email address for communications?

Accepted Answer

Yes, to change or update your preferred email address for all study correspondence, please send us a note with this request to contact@embarc-study.org along with the subject line “change of email address”.

Question 25

How do I obtain an electronic copy of my COVID-19 vaccine card?

Accepted Answer

There are several ways to obtain an electronic copy of your COVID-19 vaccine records.   If you have a hard copy record, you can take photo with your phone and email this to yourself or to our study staff at contact@embarc-study.org with the subject line: "vaccine record for upload".   If you do not have a hard copy record, you can follow these steps below to sign up for a digital COVID-19 vaccine card: Go to https://myvaccinerecord.cdph.ca.gov/ Enter your first name, last name, and date of birth. Enter your mobile phone number OR e-mail address and create a 4-digit PIN. This will allow you to securely access your vaccine record. Check the box and click “Submit.” You should receive a text message or e-mail (depending on which you provided above) with a link to your vaccine record. This process usually takes a few minutes, though it can also take up to 24 hours. Click the link. You will be prompted to enter the PIN you created in step 4. You should be directed to your digital vaccine record. The record contains a QR code as well as your name, date of birth, vaccine date(s), and vaccine type(s). Please take a screenshot of your name, date of birth, vaccine date(s), and vaccine type(s).  If you are completing this process for one of our research health surveys, please upload your vaccine directly in the survey if you received your vaccination outside of Cedars-Sinai Medical Center. If you have any trouble uploading your file into the survey form, please feel free to e-mail the screenshot to our secure e-mail address at contact@embarc-study.org.

Question 26

How do I obtain a PCR nasopharyngeal swab test for COVID-19?

Accepted Answer

Cedars-Sinai employees are able to obtain easy access COVID-19 testing via the drive through site at Thalians.   To schedule if you have symptoms, click on: https://csmc.service-now.com/ehscovidassessment or email: groupcovidemployeetesting@cshs.org   To schedule if you have no symptoms, click on: https://csmc.service-now.com/thalianscovidtesting   Cedars-Sinai patients can obtain COVID-19 testing via their Cedars-Sinai physician or urgent care by clicking here: https://www.cedars-sinai.org/programs/urgent-care.html

Question 27

When and how will I receive my antibody level test results?

Accepted Answer

Our research team sends all collected blood samples to the Abbott research laboratories on a weekly schedule, with results returned within 4 to 6 weeks following the date of blood draw. After we receive your results, we will email them directly to the email address that you provided. Please note that these results will not be uploaded into the CS-Link EPIC electronic medical records system. There are a few reasons why results are not returned more quickly. Many commercially available assays provide qualitative results (present vs absent) which can be returned faster. Our research assays provide quantitative results (numeric values representing antibody levels), which can offer more detailed information on changes over time and the extent to which higher antibody levels may represent response to infection versus response to vaccine or response to both. However, these more detailed antibody measurements take longer to run. In addition, because our assays are being performed in a state-of-the-art research laboratory, the samples need to be batched shipped to the research laboratory where all sample assays undergo research grade quality control and quality assurance procedures prior to the return of results.

Question 28

Should I be worried if my antibody levels are low when measured after I was vaccinated?

Accepted Answer

Although antibody levels may be lower or higher in some people compared to others, any value above the reference cutoff is considered to be a “positive” value. There are some people who will have a positive value appear earlier or later in relation to the timing of their prior vaccination dose, and some people whose positive value appears after two or more doses instead of one dose. Ongoing studies are being conducted to understand how even having a low antibody level measured after receiving vaccine does not necessarily mean that the immune system has not responded favorably to the vaccination.

Question 29

What do antibody levels mean in terms of vaccine effectiveness?

Accepted Answer

Although the level of an antibody response to vaccination may be somewhat correlated to effectiveness of the vaccine, this link is uncertain and an area of ongoing research.

Question 30

Is there a "normal" range of antibody level after vaccination?"

Accepted Answer

There is currently no established “normal” range for antibody levels, in part because antibody levels measured in the blood can vary in relation to many factors. For any antibody level that is above the reference cutoff that was provided, this level can be considered to be a “positive” value representing presence of antibodies.

Question 31

Is it possible to receive more details about my antibody levels including subtypes of antibodies and neutralizing activity?

Accepted Answer

Our partner laboratory does not currently provide more specific or detailed measures of antibody levels at present. Some specialized antibody measures require ongoing investigation before they can be considered sufficiently validated for reporting back to participants and being subject to potential interpretation within a clinical context. If any additional testing results become available and are considered appropriate for returning to participants, we will let all study participants know.