Long COVIDPhase 2LOCITTNCT07128082
The Long COVID Treatment Trial
A Phase 2 study testing Tirzepatide in people with Long COVID, run by Scripps Translational Science Institute at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Long COVID
- What is being tested?
- Tirzepatide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Oct 2025to Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Long COVID
- Being tested
- Tirzepatide, Placebo
- Medical subject headings
- Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TirzepatideDrug
The treatment group will receive the study medication (tirzepatide) for a 12 month period starting with a 2.5mg dose once a week.
PlaceboDrug
Participants in the control group will receive a placebo instead of active study medication for a 12 month period.
| Study group | Role | What they receive |
|---|---|---|
| 500 Participants will be randomized to receive placebo instead of active study medication. | Placebo comparator | Not described Receives: Drug: Placebo |
| 500 Participants will be randomized to receive active study medication. | Active comparator | Not described Receives: Drug: Tirzepatide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Objective 1: Changes in fatigue severity score, measured by Fatigue Severity Scale (FSS)
The average difference in Fatigue Severity Scale (minimum score 9, maximum score 63, with higher scores indicating worse fatigue) between treatment and control groups of adults with Long COVID at month 3 or month 12 after study start
Measured: 12 months
Secondary outcomes (3)
Secondary Outcome: Changes in overall health, measured by European Quality of Life 5 day, 5 level (EQ-5D-5L) scores
EQ-5D-5L is a quality of life survey with a minimum score of 5 and a maximum score of 25, with a higher score indicating worse quality of life.
Measured: 12 months
Secondary Outcome: Presence of and changes in post-exertional malaise, a condition that occurs in subsets of Long COVID and IACIs, measured by DePaul Symptom Questionnaire Post Exertional Malaise (DSQ-PEM)
DSQ-PEM evaluates the presence or absence of PEM and myalgic encephalomyelitis / chronic fatigue syndrome (ME/CFS)
Measured: 12 month
Secondary Outcome: Changes in functional capacity as measured by Functional Capacity (FUNCAP) survey
The 27-question version of FUNCAP has a minimum score of 0 and a maximum score of 162, with a lower score indicating lower functional capacity.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2025
- Study start30 Oct 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Long COVIDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Scripps Translational Science Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Schmidt Initiative for Long COVID
- Responsible party
- Sponsor
- Investigators
- Julia Moore Vogel, Principal investigator, Scripps Translational Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07128082
- Sponsor's protocol ID
- LOCITT-T
- Acronym
- LOCITT
- Status last verified
- Dec 2025
- First submitted
- 14 Aug 2025
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: The investigators may share the coded study data with researchers outside of Scripps Research. Before doing so, they will ensure that nothing in the data can identify the participant directly.
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Long COVID Treatment Trial
- ClinicalTrials.gov ID
- NCT07128082
- Acronym / sponsor ID
- LOCITT / LOCITT-T
- Conditions
- Long COVID
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Scripps Translational Science InstituteUniversity, hospital or other
- Collaborators
- Schmidt Initiative for Long COVID
- Study start
- 30 Oct 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 17 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 500 Participants will be randomized to receive placebo instead of active study medication. | Placebo comparator | Drug: Placebo |
| 500 Participants will be randomized to receive active study medication. | Active comparator | Drug: Tirzepatide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TirzepatideThe treatment group will receive the study medication (tirzepatide) for a 12 month period starting with a 2.5mg dose once a week. | Drug | 500 Participants will be randomized to receive active study medication. |
| PlaceboParticipants in the control group will receive a placebo instead of active study medication for a 12 month period. | Drug | 500 Participants will be randomized to receive placebo instead of active study medication. |
Primary outcome
Primary Objective 1: Changes in fatigue severity score, measured by Fatigue Severity Scale (FSS)
Time frame: 12 months
The average difference in Fatigue Severity Scale (minimum score 9, maximum score 63, with higher scores indicating worse fatigue) between treatment and control groups of adults with Long COVID at month 3 or month 12 after study start
3 secondary outcomes
Secondary Outcome: Changes in overall health, measured by European Quality of Life 5 day, 5 level (EQ-5D-5L) scores
Time frame: 12 months
Secondary Outcome: Presence of and changes in post-exertional malaise, a condition that occurs in subsets of Long COVID and IACIs, measured by DePaul Symptom Questionnaire Post Exertional Malaise (DSQ-PEM)
Time frame: 12 month
Secondary Outcome: Changes in functional capacity as measured by Functional Capacity (FUNCAP) survey
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
- Individual participant dataSharing planned: No. The investigators may share the coded study data with researchers outside of Scripps Research. Before doing so, they will ensure that nothing in the data can identify the participant directly.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julia Moore Vogel principal investigator
Scripps Translational Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tirzepatide in people with Long COVID, run by Scripps Translational Science Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Objective 1: Changes in fatigue severity score, measured by Fatigue Severity Scale (FSS) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025.