This is a registry record, not a result. A trial being listed, recruiting or completed says nothing by itself about whether the compound works or is safe.
| Registry number | NCT05022303 |
|---|---|
| Status | Terminated |
| Phase | Phase 2 |
| Sponsor | Massachusetts General Hospital |
| Enrollment | 12 participants |
| Design | Interventional, Randomized, Parallel, Masking: Double |
| Conditions | Covid19; Multisystem Inflammatory Syndrome in Children |
| Interventions | Larazotide Acetate; Placebo |
| Start | Oct 1, 2021 |
| Primary completion | May 15, 2024 |
| Study completion | May 15, 2024 |
| Results posted | Not yet |
| Registry last updated | Jun 13, 2024 |
Compounds on this site that cite this trial
What the registry says the trial is about
The primary aim of this study is to evaluate the efficacy and safety of AT1001 versus placebo in pediatric patients with SARS-CoV-2 infection who experience early signs of MIS-C and are at high risk of progression.
AT1001 10 μg/kg/dose up to 500 μg/dose (rounded to the nearest 50 μg) or matching placebo will be administered orally four times a day (QID) to the standard of care for MIS-C.
Primary outcomes
These are what the trial was designed to measure first. They are registered in advance, which is what makes a later result checkable.
| Outcome measure | Time frame |
|---|---|
| Evaluate the efficacy and safety of AT1001 versus placebo on mitigating symptoms of MIS-C | 24 weeks |
| Determine proportion of participants with improvement in MIS-C related GI symptoms and no progression of disease | 24 weeks |
11 secondary outcomes also registered. See the registry record for the full list.
Source: ClinicalTrials.gov (U.S. National Library of Medicine). Last checked against the registry on Oct 3, 2026. See the trial changes feed for what has changed recently.
