Reviews
Summary
Positives
- Children with MIS-C treated with larazotide cleared circulating SARS-CoV-2 spike protein within one day versus 10 days for untreated children and saw faster GI symptom resolution, per a Science Translational Medicine trial report.
- A Phase 2a trial in pediatric MIS-C patients showed adjuvant larazotide produced quicker return to usual activities with a favorable tolerability profile, per a Critical Care Explorations report.
Negatives
- In the celiac literature, patients commonly describe headache, urinary symptoms, and upper respiratory complaints during larazotide dosing, per a ScienceDirect celiac meta-analysis.
- Long COVID adults remain unstudied outside the active trial, so patients have no real-world data on whether responses match the pediatric MIS-C results, per the Reagan-Udall trial listing.
Hurdles & Side Effects
- Larazotide is not commercially available outside of clinical trials, so patients can only access it by enrolling at the active Phase 2a Long COVID study site, per the Mass General Brigham Rally enrollment page.
- Patients must demonstrate documented SARS-CoV-2 antigenemia to qualify, which requires specialized testing not offered at most clinics, per the NCT05747534 trial registry entry.
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