The Long COVID Treatment Trial

What Was Tested

The trial (phase 2) is built around Tirzepatide.

A randomized control trial will allow them 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.

It had two arms (groups): 500 Participants will be randomized to receive placebo instead of active study medication. (placebo comparator) and 500 Participants will be randomized to receive active study medication. (active comparator).

The registry classes the interventions as drug.

Who Took Part

1000 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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. Adverse Event reporting. Use of wearable activity tracker.

The full record lists 9 inclusion and 15 exclusion criteria; among the exclusions: 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.

How the Study Was Run

The set-up was randomized, parallel-group and triple-blind.

Because people in this Tirzepatide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Tirzepatide group and the comparison group ran side by side rather than switching.

Neither the participants nor the staff measuring them knew who was on Tirzepatide, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider and investigator.

It started in 2025-10-30 with completion listed for 2026-12.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Primary Objective 1: Changes in fatigue severity score, measured by Fatigue Severity Scale (FSS) (time frame: 12 months).

It also tracked 3 secondary outcomes, for example Secondary Outcome: Changes in overall health, measured by European Quality of Life 5 day, 5 level (EQ-5D-5L) scores and Secondary Outcome: Changes in functional capacity as measured by Functional Capacity (FUNCAP) survey.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Tirzepatide in 1000 people.

With 1000 participants it is a large trial for this field.

Its status is active not recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Tirzepatide compound page, all human trials.