AT1001 for the Treatment of COVID-19 Related MIS-C

What Was Tested

The trial (phase 2) is built around Larazotide.

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

Matching placebo will be administered orally four times a day (QID) to the standard of care for MIS-C.

The registry classes the interventions as drug.

More on the Plan

Eligible participants (N=20) will be treated with AT1001 or matching placebo orally four times a day (QID) for up to 21 days as an add-on to standard of care.

Safety monitoring, including physical examination, vitals, and clinical laboratory testing will be performed during the screening phase, periodically during treatment phase and at the follow-up phase.

Adverse events and concomitant medications will be recorded during the entire study.

Total duration of the participants' participation in the study is approximately 24 weeks (with 21 days treatment period).

Who Took Part

The registry lists 12 actual participants took part.

It was open to people of any sex aged from 1 Month up to 21 years.

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

Examples of who could join: Pediatric patients with or without comorbidity. Age ≥ 1 month to \< 21 years. Confirmed MIS-C by signs and symptoms as detailed by the CDC Health Advisory (https://www.cdc.gov/mis-c/hcp/; May 14, 2020). Persistent fever/chills (\>38.0°C for ≥24 hours, or report of subjective fever lasting ≥24 hours); AND. One or more laboratory parameters (evidence of inflammation); AND,.

The full record lists 6 inclusion and 6 exclusion criteria; among the exclusions: female participants pregnant and/or lactating; female participant has childbearing potential and is unwilling to use an acceptable method of birth control for the duration of the study; known hypersensitivity to any of the formulation components of at1001.

How the Study Was Run

Design: randomized, parallel-group and double-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.

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

Those kept unaware of assignments: participant and investigator.

It started in 2021-10-01 with completion listed for 2024-05-15.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 11 secondary outcomes, for example Determine the impact of AT1001 on infectious and inflammatory markers of MIS-C, Determine the impact of AT1001 on re-presentation to medical care for MISC-related symptoms after discharge, Determine the impact of AT1001 on change from baseline in levels of IgM, IgG, and IgA antibodies against SARS CoV-2, Determine the impact of AT1001 on change from baseline in levels of inflammatory markers (CRP, d-dimer, ferritin), Determine the impact of AT1001 on normalization of SARS-CoV-2 Spike, S1 and nucleocapsid and Determine the impact of AT1001 on change from baseline in levels of zonulin.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Larazotide in 12 people.

Its size is small, so on its own it can only give an early look.

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

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