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LOCITT

Active not recruitingPhase 2

The Long COVID Treatment Trial

Asset

Tirzepatide

Subcutaneous · GLP-1 / GIP dual

Listed sites

1

Recruiting sites

Enrollment

1,000

actual

Study population

COVID / long COVID

Key I/E criterion

Primary endpoint

Primary Objective 1

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07128082
Org study IDLOCITT-T

Timeline

Milestones

Study first posted2025-08-17actual
Study start2025-10-30actual
Last update posted2025-12-23actual
Primary completion2026-12estimated (month precision)
Study completion2026-12estimated (month precision)

Assets

Investigational agents

Study populations

Who this study enrolls

COVID / long COVID

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

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

Endpoints (4)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Patient-reported / QoL

4 endpoints
Primary/protocol endpoint

Primary Objective 1: Changes in fatigue severity score, measured by Fatigue Severity Scale (FSS)

Time frame:12 months

change from baseline, improvement

Secondary/protocol endpoint

Secondary Outcome: Changes in overall health, measured by European Quality of Life 5 day, 5 level (EQ-5D-5L) scores

Time frame:12 months

EQ-5D index

change from baseline, improvement

Secondary/protocol endpoint

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

categorical status, improvement

Secondary/protocol endpoint

Secondary Outcome: Changes in functional capacity as measured by Functional Capacity (FUNCAP) survey

Time frame:12 months

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.