Trial · Interventional

TerminatedPhase 2Registry data

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

NCTNCT05022303Other id2021P002143

Open at ClinicalTrials.govAsk about this trial

This trial was stopped early.

Reason given at the registry: Decline in MISC cases

Overview

Status: Terminated
Phase: Phase 2
Enrollment: 12 participants (actual)
Sponsor: Massachusetts General Hospital · Other
Design: Randomized · Double masking
Countries: 1 country
United States
Start: 1 Oct 2021
Primary completion: 15 May 2024
Completion: 15 May 2024
First posted: 26 Aug 2021
Last update posted: 13 Jun 2024
Conditions: Covid19 · Multisystem Inflammatory Syndrome in Children

Timeline

1 trial · 1 stopped early

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20212022202320242025

Ph 2
AT1001 for the Treatment of COVID-19 Related MIS-C
NCT05022303
1 Oct 2021 to 15 May 2024
Terminated
Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

Larazotide AcetateDrug
PlaceboDrug

Arms2

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

Primary outcomes2

Outcomes the sponsor listed as primary.

Evaluate the efficacy and safety of AT1001 versus placebo on mitigating symptoms of MIS-C
Time frame · 24 weeks
Registry description
• 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.
Determine proportion of participants with improvement in MIS-C related GI symptoms and no progression of disease
Time frame · 24 weeks
Registry description
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.

Secondary outcomes(11)

Determine the impact of AT1001 on infectious and inflammatory markers of MIS-C
Time frame · 24 weeks
Registry description
Secondary aims of this study include determining the impact of AT1001 on infectious and inflammatory markers of MIS-C.
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.
Time frame · 24 weeks
Determine the impact of AT1001 on length of stay in hospital (days from baseline to readiness to discharge).
Time frame · 24 weeks
Determine the impact of AT1001 on re-presentation to medical care for MISC-related symptoms after discharge.
Time frame · 24 weeks
Determine the impact of AT1001 on need for escalation of care (eg, transfer from hospital ward to ICU; supplemental oxygen; mechanical ventilation).
Time frame · 24 weeks
Registry description
Transfer from hospital ward to ICU; supplemental oxygen; mechanical ventilation.
Determine the impact of AT1001 on change from baseline in additional organ system(s) involvement during acute presentation/hospitalization, as identified by clinical assessment and clinical laboratory tests.
Time frame · 24 weeks
Determine the impact of AT1001 on change from baseline in levels of IgM, IgG, and IgA antibodies against SARS CoV-2.
Time frame · 24 weeks
Determine the impact of AT1001 on change from baseline in levels of inflammatory markers (CRP, d-dimer, ferritin).
Time frame · 24 weeks
Determine the impact of AT1001 on normalization of SARS-CoV-2 Spike, S1 and nucleocapsid.
Time frame · 24 weeks
Determine the impact of AT1001 on change from baseline in levels of zonulin.
Time frame · 24 weeks
Determine the impact of AT1001 on change in mortality (all causes)
Time frame · 24 weeks

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2025

4 results

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

Yonker et al. 2025Science translational medicinecited by 2

PMID 40737433DOI 10.1126/scitranslmed.adu4284PUB-40737433

Full text at the publisher4 results

Publisher page See results (4)

Eligibility

Who could join, as posted.

Sex: All
Age: from 1 Month up to 21 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: 1. Pediatric patients with or without comorbidity 2. Age ≥ 1 month to \< 21 years 3. Confirmed MIS-C by signs and symptoms as detailed by the CDC Health Advisory (https://www.cdc.gov/mis-c/hcp/; May 14, 2020) 1. Persistent fever/chills (\>38.0°C for ≥24 hours, or report of subjective fever lasting ≥24 hours); AND 2. One or more laboratory parameters (evidence of inflammation); AND, i) elevated C-reactive protein (CRP) ii) elevated erythrocyte sedimentation rate (ESR) iii) elevated ferritin iv) elevated lactic acid dehydrogenase (LDH) v) elevated d-dimer vi) elevated fibrinogen vii) elevated procalcitonin viii) elevated interleukin 6 (IL-6) ix) increased neutrophils x) reduced lymphocytes xi) low albumin c) Evidence of clinically severe illness requiring hospitalization, with multisystem (\>2) organ involvement (cardiac, renal, respiratory, hematologic, gastrointestinal, dermatologic, or neurological)-MUST include GI symptoms, such as nausea, vomiting, diarrhea and/or abdominal pain; AND, d) No alternative plausible diagnoses; AND e) Positive for current or recent SARS-CoV-2 infection by RT-PCR, serology, or antigen test 4. Subject (or legal authorized representative) capable of understanding and signing an informed consent form and assent form, when appropriate. Exclusion Criteria: 1. Female participants pregnant and/or lactating. 2. Female participant has childbearing potential and is unwilling to use an acceptable method of birth control for the duration of the study. 3. Participant has a significant co-morbid disease that by the Investigator's determination would make the participant unsuitable for enrollment, including unstable medical conditions. 4. Participation in any other clinical investigation using an experimental drug within 30 days prior to screening or intends to participate in another clinical study while participating in AT1001 MIS-C 101 study. 5. Have participated in a blood/plasma donation or blood loss greater than 400 mL within 90 days, or greater than 200 mL within 30 days prior to Screening. 6. Known hypersensitivity to any of the formulation components of AT1001.

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