1000 Participants Needed

Tirzepatide for Post-COVID Syndrome

(LOCITT Trial)

AG
RF
Overseen ByRomina Foster-Bonds
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Scripps Translational Science Institute
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if tirzepatide, a medication used to manage blood sugar levels, can alleviate symptoms of Long COVID, a condition that persists after a COVID-19 infection and affects various body parts. Participants will be divided into two groups: one will take tirzepatide, and the other will take a placebo (a pill with no active medicine) for a year, all from home. The study seeks participants in the U.S. who have experienced Long COVID symptoms for at least three months and suffer from significant fatigue. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, you cannot participate if you are already taking tirzepatide or another similar medication.

Is there any evidence suggesting that tirzepatide is likely to be safe for humans?

Research shows that tirzepatide has been tested in people with type 2 diabetes. In these studies, participants generally tolerated it well for up to 104 weeks. Some experienced side effects, mostly mild ones like nausea and diarrhea, while serious issues were rare.

Another study examined real-world data after tirzepatide received approval for type 2 diabetes. This study found some unwanted side effects, but they were uncommon. Since tirzepatide is approved for another condition, the treatment's safety appears well-understood. However, using tirzepatide for Long COVID remains under investigation, so its safety for this condition is not fully known yet.12345

Why do researchers think this study treatment might be promising for Long COVID?

Tirzepatide is unique because it targets both the GLP-1 and GIP receptors, offering a dual-action approach that could address the complex symptoms of post-COVID syndrome. Unlike the standard treatments, which mainly focus on managing individual symptoms, tirzepatide has the potential to regulate multiple metabolic pathways simultaneously. Researchers are excited about this treatment because it may offer a more comprehensive and effective solution for patients suffering from the lingering effects of COVID-19, potentially improving outcomes more significantly than current options.

What evidence suggests that tirzepatide might be an effective treatment for Long COVID?

Research shows that tirzepatide, also known as Zepbound, might help people with Long COVID. Studies suggest it can lower inflammation, particularly in the brain. Reports from patients indicate that 60% to 90% of those with Long COVID felt better when using tirzepatide. This trial will compare tirzepatide to a placebo to evaluate its effectiveness for Long COVID. Tirzepatide has already proven safe and effective for other conditions, such as obesity, for over a year without major side effects. These findings offer hope that tirzepatide could ease symptoms for those with Long COVID.12356

Who Is on the Research Team?

JM

Julia Moore Vogel

Principal Investigator

Scripps Translational Research Institute

Are You a Good Fit for This Trial?

This trial is for adults over 18 living in the US who have Long COVID, defined as a chronic condition from SARS-CoV-2 lasting at least 3 months. Participants need internet access, can read English or Spanish, and must consent to take medication, complete surveys, report side effects and weight changes, use an activity tracker, and possibly do blood collections at home.

Inclusion Criteria

I have a device that can connect to the internet.
I have read and understood the consent form.
I follow a specific medication schedule.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants take tirzepatide or placebo and complete study surveys remotely

12 months
All tasks are done remotely

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Tirzepatide
Trial Overview The study tests if tirzepatide (Zepbound) reduces Long COVID symptoms compared to a placebo. It's a randomized control trial with half of participants on medication and half on placebo for one year. All activities are done remotely.
How Is the Trial Designed?
2Treatment groups
Active Control
Placebo Group
Group I: 500 Participants will be randomized to receive active study medication.Active Control1 Intervention
Group II: 500 Participants will be randomized to receive placebo instead of active study medication.Placebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Scripps Translational Science Institute

Lead Sponsor

Trials
53
Recruited
572,000+

Schmidt Initiative for Long COVID

Collaborator

Citations

NCT07128082 | The Long COVID Treatment TrialThe goal of this study is to determine whether a medicine called tirzepatide, also called Zepbound, can reduce symptoms of Long COVID. A randomized control ...
2.longcovid.scripps.edulongcovid.scripps.edu/locitt-t/
LoCITT-T - Long COVID Treatment TrialThis study will analyze if tirzepatide can help reduce symptoms in particular by reducing inflammation, primarily neuroinflammation.
Obesity drug seen as effective for long COVID, gets clinical ...But anecdotal evidence that 60% to 90% of long COVID sufferers were helped by tirzepatide has given her hope. “I was blown away by that and ...
Long‐term efficacy and safety of tirzepatide in participants ...These results may provide evidence for the efficacy of tirzepatide that lasts beyond 52 weeks, without a rebound in body weight during long‐term use.
Tirzepatide for Post-COVID Syndrome · Info for ParticipantsThe goal of this study is to determine whether a medicine called tirzepatide, also called Zepbound, can reduce symptoms of Long COVID.
Real-World Safety Concerns of TirzepatideDespite its efficacy, real-world safety data remain limited. This study analyzed post-marketing adverse events (AEs) associated with tirzepatide using the FDA ...
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