Trial · NCT05022303
AT1001 for the Treatment of COVID-19 Related MIS-C
NCT05022303, Phase 2, Terminated, Massachusetts General Hospital
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. AT1001 for the Treatment of COVID-19 Related MIS-C. Trials, record NCT05022303. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05022303
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- AT1001 for the Treatment of COVID-19 Related MIS-C
- NCT number
- NCT05022303
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 12 participants, actual
- Lead sponsor
- Massachusetts General Hospital
- Conditions
- Covid19, Multisystem Inflammatory Syndrome in Children
- Interventions
- Larazotide Acetate, Placebo
- First posted
- 2021-08-26
- Last updated
- 2024-06-13
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Evaluate the efficacy and safety of AT1001 versus placebo on mitigating symptoms of MIS-C | 24 weeks | • 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. |
| Primary | Determine proportion of participants with improvement in MIS-C related GI symptoms and no progression of disease | 24 weeks | 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 | Determine the impact of AT1001 on infectious and inflammatory markers of MIS-C | 24 weeks | Secondary aims of this study include determining the impact of AT1001 on infectious and inflammatory markers of MIS-C. |
| Secondary | 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 | |
| Secondary | Determine the impact of AT1001 on length of stay in hospital (days from baseline to readiness to discharge). | 24 weeks | |
| Secondary | Determine the impact of AT1001 on re-presentation to medical care for MISC-related symptoms after discharge. | 24 weeks | |
| Secondary | Determine the impact of AT1001 on need for escalation of care (eg, transfer from hospital ward to ICU; supplemental oxygen; mechanical ventilation). | 24 weeks | Transfer from hospital ward to ICU; supplemental oxygen; mechanical ventilation. |
| Secondary | 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. | 24 weeks | |
| Secondary | Determine the impact of AT1001 on change from baseline in levels of IgM, IgG, and IgA antibodies against SARS CoV-2. | 24 weeks | |
| Secondary | Determine the impact of AT1001 on change from baseline in levels of inflammatory markers (CRP, d-dimer, ferritin). | 24 weeks |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 40737433 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05022303
GET https://conductscience.org/api/trials/v1/NCT05022303/registered