Viral spike antigen clearance and augmented recovery in children with post-COVID multisystem inflammatory syndrome treated with larazotide.

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 and 4 more

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Lok J, El Saleeby C, Walt DR, Fasano A

Science translational medicine30 Jul 2025Cited by 2 (Europe PMC)

PMID40737433DOI10.1126/scitranslmed.adu4284PepBankPUB-40737433

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Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: Publisher copyright. Results still quote short attributed sentences.

Results from this study4

4 results from studies that gave the peptide. 4 results from people.

01HumanRandomized controlled trialSafety outcome
In children with MISC, no larazotide-related adverse events were reported.
In plain wordsIn children with MISC, no adverse events related to larazotide were reported.
Peptide
Larazotide
Outcome
Not applicableLarazotide-related adverse events
Study
n = 12
Outcome group
Adverse events · Whole body
Studied dose
Dose not stated · 3 weeksAs given in this study (human).
Source sentences
Summary
No larazotide-related adverse events were reported.
3 context sentences(design, population, supporting numbers)
Summary · context
Patients were monitored for 24 weeks for safety follow-up.
Summary · context
Here, we report results from a phase 2a randomized, double-blind, placebo-controlled clinical trial testing the zonulin antagonist larazotide in 12 children with MISC with a median age of 5.7 years.
Summary · context
Children were enrolled during hospitalization for acute MISC and were treated with adjuvant larazotide therapy four times daily for 3 weeks.
Report a problemFND-4073743301
02HumanRandomized controlled trialEfficacy outcome
In children with MISC, larazotide accelerated resolution of gastrointestinal symptoms compared with placebo.
In plain wordsIn children with MISC, larazotide resolved gut symptoms faster than placebo.
Peptide
Larazotide
Outcome
IncreaseResolution of gastrointestinal symptoms
Study
n = 12
Comparator
placebo
Outcome group
Gastrointestinal protection · Gastrointestinal
Studied dose
Dose not stated · 3 weeksAs given in this study (human).
Source sentences
Summary
Children treated with larazotide displayed faster resolution of gastrointestinal symptoms, faster clearance of spike antigen, and a faster return to usual activities.
2 context sentences(design, population, supporting numbers)
Summary · context
Here, we report results from a phase 2a randomized, double-blind, placebo-controlled clinical trial testing the zonulin antagonist larazotide in 12 children with MISC with a median age of 5.7 years.
Summary · context
Children were enrolled during hospitalization for acute MISC and were treated with adjuvant larazotide therapy four times daily for 3 weeks.
Report a problemFND-4073743302
03HumanRandomized controlled trialEfficacy outcome
In children with MISC, larazotide accelerated spike antigen clearance compared with placebo.
In plain wordsIn children with MISC, larazotide cleared spike antigen faster than placebo.
Peptide
Larazotide
Outcome
IncreaseSpike antigen clearance
Study
n = 12
Comparator
placebo
Outcome group
Antiviral activity · Infection
Studied dose
Dose not stated · 3 weeksAs given in this study (human).
Source sentences
Summary
Children treated with larazotide displayed faster resolution of gastrointestinal symptoms, faster clearance of spike antigen, and a faster return to usual activities.
2 context sentences(design, population, supporting numbers)
Summary · context
Here, we report results from a phase 2a randomized, double-blind, placebo-controlled clinical trial testing the zonulin antagonist larazotide in 12 children with MISC with a median age of 5.7 years.
Summary · context
Children were enrolled during hospitalization for acute MISC and were treated with adjuvant larazotide therapy four times daily for 3 weeks.
Report a problemFND-4073743303
04HumanRandomized controlled trialEfficacy outcome
In children with MISC, larazotide accelerated return to usual activities compared with placebo.
In plain wordsIn children with MISC, larazotide enabled a faster return to usual activities than placebo.
Peptide
Larazotide
Outcome
IncreaseReturn to usual activities
Study
n = 12
Comparator
placebo
Outcome group
Exercise and physical function · Whole body
Studied dose
Dose not stated · 3 weeksAs given in this study (human).
Source sentences
Summary
Children treated with larazotide displayed faster resolution of gastrointestinal symptoms, faster clearance of spike antigen, and a faster return to usual activities.
2 context sentences(design, population, supporting numbers)
Summary · context
Here, we report results from a phase 2a randomized, double-blind, placebo-controlled clinical trial testing the zonulin antagonist larazotide in 12 children with MISC with a median age of 5.7 years.
Summary · context
Children were enrolled during hospitalization for acute MISC and were treated with adjuvant larazotide therapy four times daily for 3 weeks.
Report a problemFND-4073743304

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · 1 stopped early · source ClinicalTrials.gov (opens in a new tab)

TerminatedPhase 2NCT05022303

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

Massachusetts General Hospitaln = 121 Oct 2021 to 15 May 2024

Covid19 · Multisystem Inflammatory Syndrome in Children

Trial page ClinicalTrials.govUpdated 13 Jun 2024

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

Version 2Current
22 Oct 2026, 02:26 UTC
Study results updated
Version 1
21 Oct 2026, 18:59 UTC
First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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MeSH terms

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