drugset / Trial / NCT05022303

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

NCT05022303 ↗

Phase 2 Terminated 12 enrolled Massachusetts General Hospital
RandomizedParallel-groupDouble-blindTreatment

Summary

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.

Timeline

Start
2021-10-01
Primary completion
2024-05-15
Completion
2024-05-15

Outcome

Outcome not reported

Stopped: “Decline in MISC cases”

Drugs

EvaluationDrugModalityDoseRoute
Subject Larazotide Peptide 10 ug/kg Oral
Subject Larazotide Peptide 500 ug Oral