drugset / Trial / NCT05022303
AT1001 for the Treatment of COVID-19 Related MIS-C
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Larazotide | Peptide | 10 ug/kg | Oral |
| Subject | Larazotide | Peptide | 500 ug | Oral |