The Long COVID Treatment Trial

NCT07128082 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: LOCITT-T
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• 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

  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

  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)

  12 month

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

  12 months

Study Arms (2)

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

Interventions

Tirzepatide DRUG

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

500 Participants will be randomized to receive active study medication.

Placebo 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 placebo instead of active study medication.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Schmidt Initiative for Long COVID: collaborator
• Scripps Translational Science Institute: lead

Study Sites (1)

Scripps Research

La Jolla, California, 92037, United States

Location

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome

Interventions

Tirzepatide

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide-1 Receptor; Glucagon-Like Peptide Receptors; Receptors, G-Protein-Coupled; Receptors, Cell Surface; Membrane Proteins; Proteins; Amino Acids, Peptides, and Proteins; Receptors, Gastrointestinal Hormone; Receptors, Peptide

Study Officials

• Julia Moore Vogel

  Scripps Translational Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2025
• First Posted: August 17, 2025
• Study Start: October 30, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 23, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)