How long is the study?

The second TemPredict study began on December 1st, 2020 and the study will end on April 30, 2021. It is possible researchers may seek to extend some parts of the study after April 30, 2020. If this happens, the researchers will invite you to extend your participation in the study. You may end your participation at any time by emailing TemPredict@ucsf.edu. If you are using a study-provided Oura Ring, and do not complete the study, we will mail you a return label so that you can send us back the Oura Ring.

I was not part of the first TemPredict Study. Can I join the second TemPredict Study?

We thank you for your interest in the second TemPredict study, however, recruitment for this study has closed.

Can I join if I’m pregnant or have a chronic condition?

You can join the study if you have any medical condition, including pregnancy. You can indicate this on the baseline survey. You cannot join, however, if you have already had COVID-19 or currently have COVID-19.

What are the eligibility criteria for this study?

To be eligible for this study, participants must:

• Be over the age of 18

I would like to purchase my own ring and participate in your study. Can I be reimbursed?

At this time, participation in this study is only available at specific recruitment sites. We apologize that we cannot accept everyone into the study. This study is only funded and approved to include up to 4,000 participants, and is therefore much smaller than the first TemPredict study, which had more than 65,000 participants and was able to include individuals who purchased their own Oura Rings

Are you interested in symptoms I experienced prior to joining the study?

At this time, we are not assessing symptoms you may have experienced prior to participating in TemPredict.

I think your questionnaire is missing important questions.

Thank you for this input! Making changes to surveys is very challenging to do midway through a study, but we will certainly consider any suggestions you send us at TemPredict@ucsf.edu should we have opportunities to make changes to our surveys.

Should I list symptoms unrelated to COVID-19 (or another acute illness) in the daily survey?

We ask all participants to list all symptoms as they occur, whether or not they believe they are related to COVID-19. During analysis, we will look for patterns of symptoms that identify COVID-19 as separate from other symptoms or causes. This is important so we can know how well these data allow us to identify COVID-19 specifically. If you experience any chronic symptoms due to a medical condition, please report this information in the Baseline Survey.

Can I use the Oura Ring to take my temperature?

No. The Oura Ring does not provide instantaneous temperature readings and, instead, reports deviations from your average. This average is rolling and adjusts over time as the Oura Ring collects new data. You can read more about the metrics that Oura Ring captures on the device website, ouraring.com.

How often do I need to sync my Oura Ring?

Please sync your Oura Ring every morning by opening the Oura App on your smartphone. When you skip a day of opening the Oura App, the Oura Ring starts to save fewer of the data from night to night so as to make space for the next night. Your Oura App and the researchers therefore get the most complete and best data to work with when you open the Oura App each day, which automatically syncs your Oura Ring. When you see your sleep data from the previous night, you know it’s been successfully synced.

Can I turn on airplane mode within the Oura App?

You are free to use airplane mode, as long as you sync your ring daily (ideally in the morning upon waking), which will require that you briefly turn off airplane mode. This is because airplane mode can turn off Bluetooth, which is how the ring syncs to your phone. Please note that you will need to place the ring on the charger in order to take it off of airplane mode and sync the data. Once you’ve done this, you can turn airplane mode back on until the following morning.

What if I lose the Oura Ring that the study provided to me?

If you lose the ring during the study, please contact us at TemPredict@ucsf.edu and we will see if we can help you find it. You will not be liable for the cost of the ring if you lose it during the study and we are unable to find it.

I’m eligible to receive an Oura Ring from the study. Do I have to use the ring-sizing kit?

Yes, the Oura Ring size is special. Many people find that their Oura Ring size is more than a whole size larger than their ring size, so please use the ring sizing kit to get your best fit. Furthermore, you may find that you prefer to wear your ring on a different finger.

How does the Oura Ring assess and report temperature data?

Oura continuously measures body temperature (every minute) directly from your skin rather than estimating it using your external environment. At night, your dermal (skin) temperature is closely correlated with your internal (core) temperature. Continuous dermal assessment allows for continuous monitoring each night, without disrupting the user’s lifestyle. Oura uses three negative temperature coefficient (NTC) sensors that can detect changes as small as 0.05 C. Oura does not, however, provide the user with instantaneous temperature measurements at any time. Rather, the Oura App shows the user one value each morning that represents how the user's average temperature from the previous night compares to the user's personal baseline. For example, rather than display the user’s temperature as 36.5 °C / 99.5 °F, Oura will show how much higher or lower the user's temperature is than the user's baseline (+0.1 °C/°F). It takes a few days of wearing the ring to establish the user's baseline.

If the study provides me with an Oura Ring, do I have to return the Oura Ring after the study?

If were given an Oura Ring to participate in the TemPredict study, you are able to keep the Oura Ring ($299+tax) if you complete all the study steps through April 30th, 2021. If you choose to stop participating in the study, we will provide you with a pre-paid shipping label with which to return the Oura Ring the TemPredict study provided you. To reduce packaging waste, we ask that you save the packaging that your study ring arrived in, and re-package the ring in this packaging. We will mail you a shipping label - there are no costs to you to ship the ring back to us.

How often do I need to charge my Oura Ring?

The Oura Ring battery life is approximately 4 days. Please aim to charge your Oura Ring when it has less than 25% battery life, or about every 4 days, and especially if the battery indicator in the top-right corner turns red. You can view your battery percentage by clicking on the battery indicator in the top-right corner. Good times to charge are when you are awake and sedentary (if you would like to track your activity data), including: working at your desk, watching TV, while showering, and driving in the car. Your battery must be above 10% in order to capture sleep data.

Can I view my own data with the Oura App?

Yes, you can view your own data within the Oura App. A great time to view your sleep data is in the morning when you are syncing your ring, although you are free to open the Oura App at any time of day. We recommend fully exploring the App if you’re interested, including “Trends” under the top-left menu bar.

Can I get the Oura Ring wet?

Yes. The Oura Ring is waterproof. You may wash your hands with it, go swimming with it, and exercise with it on. However, we recommend removing the ring when lifting heavy weights or doing other activities that may scratch it.

Are my data still valuable if I only wear my ring at night?

Yes! We ask that participants wear the ring each night - we understand that wearing it during the day may not be possible for you, and may not be your preference. Wearing the ring as much as you can maximally captures data that may be important, so we encourage you to wear it as often as you wish. However, the time when you are sleeping is most important.

How often do I need to charge my Oura Ring?

The Oura Ring battery life is approximately 4 days. Please aim to charge your Oura Ring when it has less than 25% battery life, or about every 4 days, and especially if the battery indicator in the top-right corner of the Oura App turns red. You can view your battery percentage by clicking on the battery indicator in the top-right corner of the Oura App. Good times to charge are when you are awake and sedentary (if you would like to track your activity data), including: working at your desk, watching TV, while showering, and driving in the car. Your battery must be above 10% in order to capture sleep data.

What do I do with the ring-sizing kit when I’m done with it?

The Oura Ring sizing kits are recyclable. Please put the kit in any recycling container when you’re done. We do not recommend sharing of these kits so as to reduce any possibilities of disease transmission.

Can the Oura Ring be used to diagnose COVID-19?

No. The Oura Ring is not a medical device and is not intended to diagnose any medical condition.

I can’t log in to my Oura account to join the TemPredict Oura Team.

If you already have an Oura account: You can join the TemPredict Oura Team by entering your Oura email at this link. If you are unable to login to your account, please confirm your Oura account email address within the Oura App under Settings. Click the three lines on the top-left corner of the screen, then “Settings,” and find where it says “Account.” Below that is your Oura account email address. If you have forgotten your Oura account password, you may reset it here: https://cloud.ouraring.com/account/forgot-password. Please check your spam folder for the password reset email and let us know if you never receive it. If you do not yet have an Oura account: First, create your Oura account by following the steps in this document [Linked to Oura Account Setup document] Next, you can join the TemPredict Oura Team by entering your Oura email at this link. If you need to reset your password, you can do so here. If there is a chance that you entered your email address incorrectly when first creating your account, please try creating another account and ensuring there are no typos. If you remember the mistake you made in typing your email address, you can login to https://www.cloud.ouraring.com and go to “My Account” on the left sidebar to change your email to the correct one. Otherwise, you can delete the app off of your phone entirely, and when you redownload it, you will have the option to create a new account.

How can I update information that I’d like to update within the Oura App?

To update your information within the Oura App, click the top-left menu bar (three lines), then “My profile.” Your information will be at the bottom of this page. Click any entry to change it. You may also change other information by tapping on “settings.”

I went to the Oura website and it's charging me $300, what do I do?

The study will provide Oura Rings for eligible participants at recruitment sites. If you picked up an Oura Ring sizing kit at one of these sites, please review the paper instructions that were inside of the kit to take the next steps to obtain your Oura Ring from the TemPredict study. Please do not follow the instructions printed on the inside of the sizing kit box but, instead, refer to the single loose-leaf page of paper instructions.

Will the algorithm you develop be made widely available?

The purpose of this study is to determine whether the algorithm actually works the way researchers expect it to. We will not know how frequently the algorithm correctly identifies early COVID-19 or influenza until the study is complete. When we finish the study, we will submit the findings for peer review by other scientists. Once the findings have completed peer review, they will be published as an article in a peer-reviewed scientific journal, which will ensure that the results are available to the public.

How can I see the data that come from this study?

We will publish the findings and you will be able to read this publication! When the study ends, we will submit the findings for peer review by other scientists. Once the findings have completed peer review, they will be published as an article in a peer-reviewed journal, which will ensure that the results are available to the public. We will be sure to alert participants like you when this is available in an email message. You can see your own Oura Ring data any time you wish, simply by opening up the Oura App.

Will you send interim reports with study information?

We do not have plans to do interim analyses because we do not expect to have enough data to have a strong analysis until the study ends on April 31st, 2021. As soon as findings are published, we will contact you (study participants) in an email message to provide you with access to the published work.

What is COVID-19 (SARS CoV-2) antibody testing and why is the TemPredict Study using it?

Antibody testing looks for antibodies to the virus that causes COVID-19 (the SARS CoV-2 virus). It usually takes more than a week after infection with COVID-19 to develop antibodies that this test would detect. Once the test turns positive, it usually stays positive for months. Importantly, the COVID-19 antibody test result indicates if you may have had COVID-19 in the past, not whether you have it right now.

I’ve heard many COVID-19 antibody tests are not very good. What are you using? Is it accurate?

It is unfortunately true that many poorly performing COVID-19 antibody tests were initially allowed on the market by the FDA, without the usual FDA review process. This has changed because the FDA now requires that manufacturers provide data on test accuracy to continue selling the test. In TemPredict, we are only using antibody tests that have been reviewed by the FDA and received emergency use authorization.

Will you share the results of my LabCorp COVID-19 antibody testing with me?

Yes! We will send you result within about a week of completing the testing, which all depends on how quickly LabCorp returns your result to us. Once your antibody result is ready, we will send you an email that contains a link to a secure portal where you can access your test result. You will need the following information to access your results:

• First letter of your first name

How are you collecting blood for the antibody testing?

After you:

1. Complete the first survey to indicate your interest in the study
2. Complete the DocuSign link, and
3. Complete the process of joining the Oura team if you already have an Oura Ring – if you do not, you will complete this step later
4. Complete the baseline survey

Will I be reimbursed for traveling to LabCorp for COVID-19 antibody testing?

While the TemPredict Study will pay for the costs of the LabCorp COVID-19 antibody testing, we apologize that we cannot compensate you for any travel to or from LabCorp for antibody testing. As a participant in the study, you would visit LabCorp two times to complete COVID-19 antibody testing. The study will provide you with your LabCorp antibody testing results that you complete at the beginning of the study and at the end of the study, at no cost.

How would my COVID-19 testing results be associated with my name or other identifying information?

We will remove your identifying information (such as your name) from your study data, including your Oura Ring data, LabCorp COVID-19 antibody testing data and Everlywell COVID-19 testing data, and self-report data, after these data pieces are linked and labeled by a non-identifying descriptor, called a participant identification number. This will result in a data set that does not include personal information, otherwise known as a “de-identified dataset,” which we will use for analysis. A separate file that links your study ID to your email address or other identifying information will be kept in an encrypted file and will be destroyed when no longer needed by the research study. Once we delete this file, it will not be possible to identify your data in the dataset. Of note, your COVID-19 testing done using the Everlywell Home Collection Kit (see separate FAQ section about Everlywell COVID-19 testing) will be registered with the name you provide during the online registration process and therefore will be visible to Everlywell. The purpose of the online registration process is so that you can log into the Everlywell system to get your testing result as soon as it is available. The Everlywell system will alert you when your result is ready. See the FAQ section specifically about the Everlywell COVID-19 testing for more details. Your COVID-19 PCR tests done using the Everlywell kits will be registered with the name you include with this test in records kept by Everlywell.

Will you be using the blood collected at LabCorp for anything other than COVID-19 antibody testing?

No. Researchers will only use your blood collected at LabCorp for COVID-19 antibody testing. LabCorp will dispose of your blood sample once the COVID-19 antibody testing is complete.

Who will have access to my data, such as my LabCorp COVID-19 antibody results and Everlywell COVID-19 Test Home Collection Kit results? Will my results be kept confidential? Will you share my information with other organizations?

Your results will be kept confidential, and will only be used for science. This means that your data will not be provided by the study to your health care providers or your health insurance company. If information from this study is published or presented at scientific meetings, your name and other personal information will not be used. Wherever feasible, laboratory tests will have only a participant identification number attached, not your name or other information. To protect your confidentiality, the link between your study ID and contact information will be carefully protected in an encrypted data file with restricted access so only a few people in the study team can access the file. People involved in the study who may have access to information like your mailing address and name will typically not have access to the actual test results. TemPredict will need to send your name and email address to Everlywell to arrange for you to receive an at-home COVID-19 testing kit. Everlywell will require you to create an online account with them (through their secure website) in which they will ask for further information including your shipping address, phone number, and other relevant information needed to send you a test kit and provide you with results. If the TemPredict Study is sending you an Oura Ring or a metagenomic testing kit, the TemPredict Study will need to provide your physical mailing address to the shipper, who will mail these items using an established mail carrier, such as USPS or UPS. Research partners outside of the University of California (including the Massachusetts Institute of Technology (MIT)) who work with study data will not have your name or identifying information, such as your email address. They will only have the participant identification number linked to your study data, including your Everlywell COVID-19 testing and metagenomic testing results. Everlywell will complete mandated reporting of positive COVID-19 testing to relevant local public health authorities and government/health agencies. Authorized representatives from the University of California, U.S. Department of Defense, U.S. Food and Drug Administration, and Oura Ring, may review your research data for the purpose of monitoring or managing the conduct of this study.

Will you be accessing my historical data once I sign up?

The TemPredict Study will be able to access your prior Oura Ring data back to January 1st, 2020, if you have prior data available. This will allow researchers to develop baseline periods for individuals prior to infection, should it occur. This date is stated in the consent form for the study.

What happens to the data that you have already collected if I withdraw from the study?

If you wish to withdraw from the study, please email us at TemPredict@ucsf.edu so we can remove you from the study. At the end of the study, when UCSF researchers access the study data, we can remove the self-report and Oura data you provided that have not yet been de-identified. To create a dataset, we assign participant identification numbers and de-identify data to maximally protect privacy of those who participate in research. Once the data have been de-identified, we will not be able to isolate your data for deletion.

I'm interested in participating. Can you clarify the comment in the consent form: Participation in research may involve a loss of confidentiality and/or privacy, but information about you will be handled as confidentially as possible.

Loss of privacy is a risk whenever information exchange occurs. This sentence in the consent form is always present in consent forms such as these. We take your privacy very seriously and UCSF adheres to best practices in research. To create a dataset, we assign participant identification numbers and de-identify data to maximally protect privacy of those who participate in research. This research is overseen by the UCSF Institutional Review Board (IRB) and the U.S. Department of Defense Human Research Protection Office (HRPO), which has reviewed all procedures of this study and deemed them to be maximally dedicated to protecting participant confidentiality.

I value my privacy and would like it protected.  I've read through your consent form and wonder if you can provide clarification of, your personal information may be given out if required by law. What laws might come in to play in the sentence?

This sentence in the consent form is always present in consent forms such as these. We take your privacy very seriously and UCSF adheres to best practices in research. To create a dataset, we assign participant identification numbers and de-identify data to maximally protect privacy of those who participate in research. This research is overseen by the UCSF Institutional Review Board (IRB) and the U.S. Department of Defense Human Research Protection Office (HRPO), which has reviewed all procedures of this study and deemed them to be maximally dedicated to protecting participant confidentiality. Where required by law, research records could be subpoenaed, but UCSF makes every effort to protect confidentiality of research subjects.

What does the Everlywell COVID-19 Test Home Collection Kit measure?

This testing kit measures whether you have active COVID-19 infection. The samples collected using the Everlywell COVID-19 Test Home Collection Kit are meant for rt-PCR tests (a specific kind of molecular PCR test) that look for the presence or absence of unique genetic sequences of the SARS-CoV-2 virus (which causes COVID-19) using a nasal swab for sample collection.

When and how do I collect my Everlywell COVID-19 Test Home Collection Kit sample? What do I do with it once I’ve collected my sample?

TemPredict study staff will contact you by phone/text/email (per the choice you made when you enrolled in the study) to instruct you to complete the Everlywell COVID-19 home testing kit. You must complete the self-collection and mail the completed kit the same day that you receive this notice from the study staff. If you do not mail your kit the same day that you collect your sample, it will not be processed. After you have been contacted by the TemPredict study team to complete the kit, you can then register the kit according to the instructions provided in the kit. Please DO NOT register your kit and DO NOT collect your sample until you have been contacted by the TemPredict study team and instructed to do so. The Everlywell COVID-19 Test Home Collection Kit will come with everything you need to collect a sample at home (generally in five minutes or less). The nasal swab tip does not need to be inserted far into your nose - only about an inch into your nostril. Please refer to the video and print instructions for more information. We strongly recommend that you check for the location of your nearest UPS shipping drop box in order to get your sample to our labs as quickly as possible. The prepaid UPS shipping label is included in the kit. Please deposit your sample in a UPS drop box before the last pick up of the day. Everlywell will ensure that your sample is processed in a CLIA-certified laboratory. You can find drop box locations on the UPS website. Important notes:

• UPS drop boxes do not operate on weekends. If you put your sample in a drop box on the weekend, you may experience a delay in shipping which can result in delayed results or sample expiration.

How soon do I get my COVID-19 testing results after I send back the Everlywell COVID-19 Test Home Collection Kit Sample?

Results are typically available within 24-28 hours after the lab begins processing the sample. All labs processing COVID-19 tests are operating Monday-Saturday. You will receive an email from Everlywell when your results are ready, and you will be able to access your results online through the Everlywell website.

Can I receive another Everlywell COVID-19 Test Home Collection Kit?

Due to limited supplies, our current plans are to issue only one COVID-19 home testing kit per participant. If study staff instruct you to complete the Everlywell COVID-19 Test Home Collection Kit, we may send you a replacement kit in case you need another during the study period. It is critical that you only complete the Everlywell COVID-19 Test Home Collection Kit when the study researchers instruct you to.

How can I track the status of my Everlywell COVID-19 Test Home Collection Kit results?

When you provide your email when you register your Everlywell Home Collection Kit online, you should receive emails confirming registration and delivery to the lab (with tracking number), and a final email when your results are ready. Once your kit has been registered, you should also be able to track processing at the lab on your Everlywell dashboard. However, due to the increase in volume and rapid turnaround time, email notifications and dashboard updates may be delayed. We recommend making a note of your tracking number on the shipping label so you can track your sample through the UPS website. If you have questions about your shipping status, please reach out to UPS at 1-888-742-5877.

Is the Everlywell COVID-19 Test Home Collection Kit authorized by the U.S. Food & Drug Administration (FDA)?

Yes, the Everlywell COVID-19 Test Home Collection Kit and our lab partners have received Emergency Use Authorization from the FDA.

What happens if I don’t collect my sample correctly?

In certain cases, if you do not provide a sufficient sample, it is possible that our partner lab will not be able to determine your test results. Staff from TemPredict will contact you if this happens to go over what to do next. Key things to note when collecting your sample:

• Your sample might not be processed if the swab is not in the tube with the saline solution

What role do medical providers have in your testing?

Everlywell COVID-19 Test Home Collection Kit results will be reviewed and approved by an independent board-certified physician. As required by law, both positive and negative results will be reported to state public health authorities.

Is it safe to send COVID-19 samples in the mail?

Everlywell collection methods follow COVID-19 infectious disease sample collection recommendations provided by the United Nations Committee of Experts on the Transport of Dangerous Goods (UN). Everlywell provides appropriate shipping materials to safely ship your sample to their partner labs. Everllywell recommends that you take precautionary measures when collecting your sample by washing your hands thoroughly, disinfecting surfaces where you will be collecting their sample and using the provided alcohol prep pad to disinfect the shipping sleeve before placing your sample in the mail (though be sure to not wipe the shipping label which could impact legibility). At-home collection can also reduce the risk of exposure from visiting doctor’s offices, hospitals and medical facilities. Everlywell provides detailed instructions in their test and online for safe collection and transport of COVID-19 samples.

How long does my sample stay usable once I’ve collected it?

Samples are generally stable for 4 days. Everlywell provides prepaid shipping materials for overnight shipping and the sample must be shipped on the same day it is collected. Your sample will not be processed if you do not ship on the same day the sample is collected – hence, study staff will never instruct you to collect a sample on a Sunday.

What will the result from the Everlywell COVID-19 Test Home Collection Kit tell me?

The results will tell you whether you had active SARS-CoV-2 Coronavirus (COVID-19) at the time when you collected your sample. If you have a positive test result, it is very likely that you have COVID-19. There is a very small chance that this test can give a positive result that is wrong (a false positive result). Your healthcare provider will work with you to determine how best to care for you based on the test results along with medical history, and your symptoms. If you have a positive result, Everlywell will offer you a telehealth consult with an independent board-certified physician. Everlywell will report your results to state public health authorities to help inform the crucial ongoing public health response. In certain cases, you may not receive a definitive result because of early infection or inadequate sampling. If this happens you will be contacted directly by a doctor to help you with planning your next steps. The test can sometimes show a negative result even if you are infected with SARS-CoV-2, the virus that causes COVID-19. This can happen if:

• It is too early in infection for the test to detect the virus.

What is the purpose of the Metagenomic Home Collection Kit?

This additional swab kit will be used to test whether you have other different possible respiratory infections, not just COVID-19 or influenza. This swab does something called metagenomic sequencing. This testing can detect viral genetic sequences from many different viruses.

What happens if I don’t collect my Metagenomic Home Collection Kit sample correctly?

In certain cases, if you are not able to provide an adequate sample, it is possible that UCSF, where these samples are being processed, will not be able to determine your test results. In this case, we will not be able to provide you with a second Metagenomic kit.

Can I receive another Metagenomic Home Collection Kit?

Due to limited supplies, we will issue only one Metagenomic testing kit per participant.

When and how do I collect my Metagenomic Home Collection Kit?

The study research team will contact you by text/email/phone to instruct you when to collect the Metagenomic sample. Do not collect your sample until after you have been contacted by TemPredict study staff. The Metagenomic Home Collection Kit will come with everything you need to collect a sample at home (generally in five minutes or less) including printable instructions. You will use the provided materials to collect a nasal swab sample. The nasal swab tip does not need to be inserted far into your nose - only about an inch into your nostril. Please refer to the instructions included in the metagenomic testing kit for how to complete the kit. It is very similar to how you complete the Everlywell kit. In order to get your sample to our labs as quickly as possible, we provide a prepaid FedEx shipping label. We strongly recommend that you put the package containing your sample in a FedEx drop box before the last pick up of the day. You can find drop box locations on the FedEx website.

How can I track the return shipping status of my Metagenomic Home Collection Kit?

We recommend making a note of your tracking number on the shipping label so you can track your sample through the FedEx website.

When will I have access to my Metagenomic Home Collection Kit results?

We will not be able to provide you with Metagenomic testing results until near the end of the study (or after the study is completed) because this is a specialized research test in which all specimens will be tested in a single batch at one time.

What is the best way to contact TemPredict Study Staff?

Please reach us at TemPredict@ucsf.edu. This is much more effective than attempting to call us. We will respond to your email as rapidly as we can.