Welcome to the Long COVID Treatment Trial-Tirzepatide (LoCITT-T)

What is this study for?

The Long COVID Treatment Trial-Tirzepatide (LoCITT-T) is a fully remote clinical trial that will study if a medicine called tirzepatide may help alleviate Long COVID symptoms. This trial could improve treatment options for those still affected by Long COVID and other chronic conditions. 

How do I know if I’m eligible?

Eligibility for LoCITT-T is determined by completing an Eligibility Survey. If you haven’t yet completed the survey, click here to get started.

I already have the MyDataHelps^TM (MDH) app. Why can’t I find the project in the MDH app?

Participants must complete an eligibility questionnaire first. If deemed eligible, you will be invited to complete Consent. Once consent is complete, you will be prompted to complete subsequent tasks in the MyDataHelps^TM app. 

Can someone help me complete the consent or study activities like surveys?

Yes. You will need to be able to complete the consent to participate, but a family member, friend or caregiver can help you read through the consent document. They can also fill out your study surveys and complete study tasks. If you need more support, you can email or schedule a video visit with the LoCITT study team.

Can I stop participating in the study?

Yes. Taking part in LoCITT-T is up to you. If you join, you can leave the study at any time. If you leave the study, no new data will be collected. Data that has already been collected can still be used in the study and will not be deleted. 

Who is sponsoring or conducting the study?

LoCITT-T is operated by Scripps Research in partnership with CareEvolution and funded by the Schmidt Initiative for Long COVID (SILC).

How long will the study last?

The study is designed to last for up to 12 months. This includes the active treatment period, where participants will take medication weekly, and periodic surveys. Participants can stop participating at any time.

Where will the study take place?

The study is completely remote. Participation will be completed entirely from home, no in-person visits needed. Participants will download the MyDataHelps^TM smartphone app by CareEvolution for remote participation, electronic health record sharing, connecting devices, completing surveys and more. The study team is available to support participants in the way that works best for them, whether that’s by phone, email or video call.

Will I be compensated for being in this study?

You can earn Amazon gift cards for being in this study. In total, you could earn up to $50 for study tasks and if selected, up to $30 if you give blood samples.

General participants: You will be compensated for filling out surveys. The amount you earn will go up over time. You can earn up to $50 if you complete surveys at all five times (start of the study, 3 months, 6 months, 9 months, and 12 months).

Select blood sample participants: If you are chosen to give at-home blood samples, you will also be compensated for doing these. The amount you earn will go up over time. You can earn up to $30 if you complete all three collections (start of the study, 6 months, and 12 months).

Which type of video call appointment should I book?

We offer a few different video call options, depending on your needs:

• Speak to a Nurse – For medical questions about the study or your health while participating.
• First Dose Video Visit – Your first appointment, where we walk you through taking your first study dose and answer questions.
• Speak to a Study Coordinator – A chance to talk about study tasks, next steps, or any concerns.

Not sure which one is right for you? Book a Speak to a Study Coordinator and we’ll help guide you.

I need to make a change to my Shipping Address.

If you need to make a shipping address change to an order that’s processing, contact the study team at longcovid-t@scripps.edu.

If you need to update your address for a future order, no action is necessary. When receiving your next shipment of medication and/or blood sample collection materials, you will be asked to confirm your address and may change it at that time. 

My devices kit is missing an item(s).

Please report the missing item through the MyDataHelps^TM app. A study coordinator will follow-up. 

If you’ve missed the opportunity to report missing items or haven’t heard from the study team, email the study team at longcovid-t@scripps.edu. When drafting your email, please include which item(s) are missing.

I need help with my Garmin wearable activity tracker.

Please refer to the resources included in the MyDataHelps^TM app Info tab. This page includes a guide and a link to connect with Garmin Customer Support.

Note to participants: You do not need to disclose that you are in a research study when connecting with Garmin Support. 

I am getting an error message when connecting my Garmin account to the study. What do I do?

Please refer to the resources included in the MyDataHelps^TM app Info tab. This page includes a guide and a link to connect with Garmin Customer Support.

Note to participants: You do not need to disclose that you are in a research study when connecting with Garmin Support. 

I’d like to learn more about the drug being studied in this trial. 

Here’s a link to the drug Instructions For Use, as well as an instructional video on how to administer the drug. 

Disclaimer: The linked video and instructions depict drawing from a vial. Your study drug package will not include a vial. Instead, you will receive pre-filled syringes that are ready to use.

Will I know if I’m selected to take the study drug?

No. Study participants will be randomly assigned to two groups: one receiving the study drug and the other receiving a placebo. The placebo looks like medicine but doesn’t have active ingredients. Including placebo participants in research helps us determine if the observed benefits are due to the treatment being tested.

When the study is complete, participants will be informed if they received treatment or placebo.

Who is Eversana?

Eversana is our study drug shipping partner. They will contact you to schedule and deliver your study drug.

How do I contact Eversana?

Eversana’s business hours are 8 AM – 5 PM Central Time (CT), Monday – Friday. The pharmacy has on-call support 24 hours a day, 7 days a week. By calling 1-877-854-3061, you will be connected with a member of the pharmacy staff.

When should I contact Eversana?

You should contact Eversana if you have any questions or concerns about your scheduled study drug delivery. Each study drug shipment will include an instruction guide that will detail the steps of how to unpack and check that study drug was kept under proper refrigerated conditions during transport. If you have questions or concerns, you can call Eversana staff who will walk you through receiving and opening the container.

What information will Eversana need to confirm and ship my study drug package?

Eversana, our shipping partner, will contact you to arrange delivery of the study drug. You will need to share your name, date of birth, and zip code to confirm your identity. Your study drug shipment will be sent after you confirm a delivery time. You or someone you authorize must sign for the study drug shipment upon delivery. 

My study drug arrived with the incorrect dosage. What should I do?

Do not administer this medication. Please report the incorrect dosage to the study team at longcovid-t@scripps.edu and follow the provided steps on returning unused medication. 

My study drug is expired or appears cloudy, colored, or has particles.

Do not administer this medication. Please report the study drug condition to the study team at longcovid-t@scripps.edu and follow the provided steps on returning unused medication. 

Is there anything I can do to prepare or reduce the pain associated with administering the injection of the study drug?

You may apply an ice pack to the injection site for 5–10 minutes before injecting to help reduce discomfort. This is optional and not required for the study.

I missed a dose of my study drug. What should I do?

If 4 days or fewer have passed since you missed your dose, take the study drug as soon as possible and log the entry in the MyDataHelps^TM app. If more than 4 days have passed, skip the missed dose and take your next dose on the regularly scheduled day.

I started a new medication and/or supplement. Can I continue taking the study drug?

New medications and/or supplements may be logged monthly during your Study Check-in. If you wish to report the change outside of your scheduled check-in, you may email the study team at longcovid-t@scripps.edu. Once reported, a study coordinator will review the entry and confirm whether it is recommended for you to continue or stop the newly added medication. 

I’m experiencing side effects. What should I do?

If you’re experiencing a serious or urgent medical emergency, like an allergic reaction or trouble breathing/chest pains, call 911 or visit your nearest Emergency Room. If you feel you are experiencing mild or moderate side effects from the study drug, please report them using the “Having symptoms or side effects” button on your Home tab. 

If you seek medical care for any side effects, please let the study team know. You can also reach us via 

• Email: longcovid-t@scripps.edu
• Phone: 858-784-9519
• Schedule a video visit 

What should I do if I damage my study drug / pre-filled syringe?

Do not use it. Contact the study team at longcovid-t@scripps.edu immediately for guidance and a replacement.

How do I dispose of my used syringe?

Put your used needle and syringe in an FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) loose needles and syringes in your household trash.

If you do not have an FDA-cleared sharps disposal container, you may use a household container that is:

• made of a heavy-duty plastic,
• can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,
• upright and stable during use,
• leak-resistant, and
• properly labeled to warn of hazardous waste inside the container.

When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA’s website at: http://www.fda.gov/safesharpsdisposal. 

Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. Do not recycle your used sharps disposal container.

What if I’m not interested in donating blood samples?

When enrolling we will ask you if you’re willing to donate blood samples. If you are selected to be in the group that donates blood samples, you may choose to not participate in this portion of the study. If you choose to not participate in the blood sample portion, you may continue to participate in the overall study. 

How many samples will I be asked to collect, and when?

If selected to be in the group that donates blood, you will be asked to collect three samples at three different time points for a total of nine collections over the course of the study. You will be prompted to collect the samples before starting the study drug, six months into the study, and again at twelve months.  

Blood samples should only be collected Monday through Thursday and need to be shipped on the same day you collect. Please check the last UPS Air Pickup Time for your local UPS store here before completing your collections.

How will the blood samples be collected?

You will collect your blood samples using an at home blood collection device called the TAP Micro Select. We will send you all the materials you need to complete the collection along with written instructions and a video guide.

My blood collection kit is missing materials. What should I do?

Please report the missing item(s) through the MyDataHelps^TM app. A study coordinator will follow-up. 

If you’ve missed the opportunity to report missing items or haven’t heard from the study team, email the study team at longcovid-t@scripps.edu. When drafting your email, please include which item(s) are missing.

I forgot to collect the blood samples before administering the first dose of the study drug. What should I do?

Please report this to the study team at longcovid-t@scripps.edu, still proceed with the collection and let them know how long after the first dose you are performing the collection.

I was unable to complete one or all of the collections. What should I do?

Please report any issues with the device to the study team. You may still ship a sample even if you think there is minimal blood in the tube. If you attempted a collection and were unable to collect blood for any reason, complete the remaining collections and ship all samples you can. In the instance of failed collections, please inform the study team. 

What’s being done with my blood samples?

The samples you donate are being shipped to different labs for various types of testing. The blood samples may be used to: 

• Understand the different genetic materials and proteins in your blood and what viruses you may have been exposed to previously. 
• Run tests to see how your body is responding to the medication.

Will I receive results from my blood sample collection?

The blood samples will allow us to see how things like proteins in the blood of people with Long COVID change over time, and in response to Tirzepatide. You may receive some of your blood results back via the study platform.