Clinical trial

The Long COVID Treatment Trial

Active, not recruiting · Phase 2 · 1 countries · Registry ID NCT07128082

Active, not recruitingPhase 2Interventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed
SexAll
Healthy volunteersNot accepted
ConditionLong COVID

Full registry criteria

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

Treatments and study arms

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.

Placebo

Drug

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

Primary outcomes

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

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Scripps Research🇺🇸 La Jolla, California, United States