AT1001 for the Treatment of Long COVID

What Was Tested

In this phase 2 trial, researchers set out to test Larazotide.

AT1001 (n=100) or placebo (n=50) will be administered orally four times a day (QID) for 21 days.

It had two arms (groups): Larazotide Acetate (AT1001) (experimental) and Placebo (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

Eligible participants (N= 150) will be treated with AT1001 (n= 100) or matching placebo (n= 50) orally four times a day (QID for 21 days).

The study will consist of two phases: I.

Baseline Visit and Treatment phase After confirming subject eligibility, a licensed physician investigator will obtain informed consent.

Subjects will be asked to complete baseline surveys (SBQ™-LC, PedsQL, and Symptom Severity Survey) to assess organ involvement and symptom severity.

Who Took Part

The registry lists 107 actual participants took part.

It was open to people of any sex aged from 7 years up to 50 years.

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

Examples of who could join: Age 7 to ≤50 years. History of SARS-CoV-2 infection, documented by positive PCR and/or antigen test.

The full record lists 3 inclusion and 11 exclusion criteria; among the exclusions: age ≤6 years or \>50 years at time of enrollment; pregnancy and/or lactation; female participant of childbearing age unwilling to use an acceptable method of birth control for the duration of the study.

How the Study Was Run

Design: randomized, parallel-group and quadruple-blind.

The participants were allocated by chance, so the Larazotide group and the comparison group should start out alike.

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

As a double-blind Larazotide study, the assignments were hidden from both participants and investigators until the end.

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

It started in 2023-05-31 with completion listed for 2026-06-18.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Adverse Event Profiling and Time to Symptom Resolution (time frame: 8 weeks).

It also tracked 1 secondary outcome, for example Cytokine profiling, Antigen Testing and Humoral and Cellular Responses.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Larazotide in 107 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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