The Long COVID Treatment Trial

Phase 2Active Not RecruitingNCT07128082

Scripps Translational Science Institute1,000 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

1,000

Conditions

Long COVID

Interventions

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Scripps Research

La Jolla, California, United States

Outcomes

Primary Outcomes

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

Time frame: 12 months

Secondary Outcomes

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.

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)

DSQ-PEM evaluates the presence or absence of PEM and myalgic encephalomyelitis / chronic fatigue syndrome (ME/CFS)

Time frame: 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.

Time frame: 12 months

Data from ClinicalTrials.gov

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