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The Long COVID Treatment Trial

NCT ID: NCT07128082

Last Updated: 2025-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-30

Study Completion Date

2026-12-31

Brief Summary

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The goal of this study is to determine whether a medicine called tirzepatide, also called Zepbound, can reduce symptoms of Long COVID. A randomized control trial will allow us to measure the effect of the treatment by having half of the participants take the medication and half take a placebo that has no medication. Participants will take the medication (or placebo) they are given and complete study surveys for 12 months. All of the study tasks are done remotely from the comfort of a participants home.

Detailed Description

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Conditions

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Long COVID

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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500 Participants will be randomized to receive placebo instead of active study medication.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Participants in the control group will receive a placebo instead of active study medication for a 12 month period.

500 Participants will be randomized to receive active study medication.

Group Type ACTIVE_COMPARATOR

Tirzepatide

Intervention Type DRUG

The treatment group will receive the study medication (tirzepatide) for a 12 month period starting with a 2.5mg dose once a week.

Interventions

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Tirzepatide

The treatment group will receive the study medication (tirzepatide) for a 12 month period starting with a 2.5mg dose once a week.

Intervention Type DRUG

Placebo

Participants in the control group will receive a placebo instead of active study medication for a 12 month period.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 18 years of age or older Living in the United States Able to read and understand English or Spanish Willing and able to participate in study interventions and activities, including;
* Access to an internet connected device
* Informed Consent
* Surveys
* Medication schedule
* Adverse Event reporting
* Weight reporting
* Use of wearable activity tracker
* Completing at home blood collections, if selected Meets the NASEM definition of Long COVID: an infection-associated chronic condition that occurs after SARS-CoV-2 infection and is present for at least 3 months as a continuous, relapsing and remitting, or progressive disease state that affects one or more organ systems 16.

Ability to verify identity Ability to verify diagnosis Agree to notify the study team if you start any other Long COVID treatments while enrolled in the study.

Complete the Fatigue Severity Scale with a minimum score of 36

Exclusion Criteria

* Certain vulnerable populations (prisoners, children, fetuses, and institutionalized individuals)
* Women who are pregnant, excluded due to unknown risks to a fetus
* Personal or family history of medullary thyroid carcinoma
* History of severe gastrointestinal disease
* Diagnosis of gastroparesis
* Worsening or chronic renal failure
* History of pancreatitis
* Multiple Endocrine Neoplasia syndrome type 2
* Known serious hypersensitivity to tirzepatide
* Already taking tirzepatide or another GLP-1 agonist
* Medication contraindications to tirzepatide
* History of suicidal attempts and/or active suicidal ideation
* Underweight (BMI under 18.5)
* Planning to undergo elective surgery or procedures requiring general anesthesia or deep sedation in the next 12 months
* Symptoms of fatigue and/or brain fog that predated infection with COVID-19
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Schmidt Initiative for Long COVID

UNKNOWN

Sponsor Role collaborator

Scripps Translational Science Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Julia Moore Vogel

Role: PRINCIPAL_INVESTIGATOR

Scripps Translational Research Institute

Locations

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Scripps Research

La Jolla, California, United States

Site Status

Countries

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United States

Other Identifiers

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LOCITT-T

Identifier Type: -

Identifier Source: org_study_id