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Outcome Measures

Primary Outcomes (2)

Evaluate the efficacy and safety of AT1001 versus placebo on mitigating symptoms of MIS-C
• 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.
24 weeks
Determine proportion of participants with improvement in MIS-C related GI symptoms and no progression of disease
Improvement in GI symptoms is defined as: * Improvement in PedsQL GI Symptoms Scales score ≥48 hours, as determined by patient or caregiver response. * AND improvement in clinical manifestation of GI symptoms, as documented by complete physical exam or clinical assessment and clinical laboratory tests or imaging. No Progression of MIS-C is defined as: * No involvement of additional organ involvement, as identified by clinical assessment and clinical laboratory tests or imaging. * AND no new onset of new or worsening GI symptoms for ≥48 hours including nausea, vomiting, diarrhea, loss of appetite, and/or abdominal pain, as determined by patient or caregiver symptom report or worsening PedsQL GI Symptoms Scales scores.
24 weeks

Secondary Outcomes (11)

Determine the impact of AT1001 on infectious and inflammatory markers of MIS-C
24 weeks
Determine the impact of AT1001 on improvement in MIS-C symptoms for ≥48 hours, as determined by patient or caregiver symptom report on MIS-C Symptom Questionnaire.
24 weeks
Determine the impact of AT1001 on length of stay in hospital (days from baseline to readiness to discharge).
24 weeks
Determine the impact of AT1001 on re-presentation to medical care for MISC-related symptoms after discharge.
24 weeks
Determine the impact of AT1001 on need for escalation of care (eg, transfer from hospital ward to ICU; supplemental oxygen; mechanical ventilation).
24 weeks
+6 more secondary outcomes

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Larazotide Acetate

EXPERIMENTAL

AT1001 10 μg/kg/dose up to 500 μg/dose (rounded to the nearest 50 μg) will be administered orally four times a day (QID) to the standard of care for MIS-C.

Drug: Larazotide Acetate

Interventions

Larazotide AcetateDrug

AT1001 10 μg/kg/dose up to 500 μg/dose (rounded to the nearest 50 μg) will be administered orally four times a day (QID) to the standard of care for MIS-C.

Also known as: AT1001

Larazotide Acetate

PlaceboDrug

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

Related Publications (1)

Yonker LM, Kane AS, Swank Z, Papadakis L, Kenyon V, Han S, Lima R, Guthrie LB, Alvarez-Carcamo B, Lahoud-Rahme M, Balaguru D, Carroll RW, Lok J, El Saleeby C, Walt DR, Fasano A. Viral spike antigen clearance and augmented recovery in children with post-COVID multisystem inflammatory syndrome treated with larazotide. Sci Transl Med. 2025 Jul 30;17(809):eadu4284. doi: 10.1126/scitranslmed.adu4284. Epub 2025 Jul 30.

PMID: 40737433DERIVED

MeSH Terms

Conditions

COVID-19pediatric multisystem inflammatory disease, COVID-19 related

Interventions

larazotide acetate

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type

interventional

Phase

phase 2

Allocation

RANDOMIZED

Masking

DOUBLE

Who Masked

PARTICIPANT, INVESTIGATOR

Masking Details

Participant and investigator blinded, Pharmacy unblinded.

Purpose

TREATMENT

Intervention Model

PARALLEL

Model Details: Placebo and drug arm (10 μg/kg/dose up to 500 μg/dose)

Sponsor Type

OTHER

Responsible Party

PRINCIPAL INVESTIGATOR

PI Title

Pulmonary Attending Physician

Study Stopped

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (11)

Study Arms (2)

Placebo

Larazotide Acetate

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (11)

Study Arms (2)

Placebo

Larazotide Acetate

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations