Registered outcomes13

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

1 to 13 of 13

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
Secondary	Determine the impact of AT1001 on normalization of SARS-CoV-2 Spike, S1 and nucleocapsid.	24 weeks
Secondary	Determine the impact of AT1001 on change from baseline in levels of zonulin.	24 weeks
Secondary	Determine the impact of AT1001 on change in mortality (all causes)	24 weeks

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

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 list from software.

Twenty rows a page, as JSON. No key.

GET https://conductscience.org/api/trials/v1/NCT05022303/registered

API reference For AI assistants