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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Placebo Comparator
500 Participants will be randomized to receive placebo instead of active study medication.
  • Drug: Placebo
    Participants in the control group will receive a placebo instead of active study medication for a 12 month period.
Active Comparator
500 Participants will be randomized to receive active study medication.
  • Drug: Tirzepatide
    The treatment group will receive the study medication (tirzepatide) for a 12 month period starting with a 2.5mg dose once a week.

Recruiting Locations

Scripps Research
La Jolla 5363943, California 5332921 92037
Contact:
Julia Moore Vogel, PhD
858-784-9519
longcovid-t@scripps.edu

More Details

NCT ID
NCT07128082
Status
Recruiting
Sponsor
Scripps Translational Science Institute

Study Contact

Andrea Goosen
858-784-5219
agoosen@scripps.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.