AT1001 for the Treatment of COVID-19 Related MIS-C
Covid19, Multisystem Inflammatory Syndrome in Children
About this trial
This is an interventional treatment trial for Covid19
Eligibility Criteria
Inclusion Criteria:
- Pediatric patients with or without comorbidity
- Age ≥ 1 month to < 21 years
Confirmed MIS-C by signs and symptoms as detailed by the CDC Health Advisory (https://www.cdc.gov/mis-c/hcp/; May 14, 2020)
- Persistent fever/chills (>38.0°C for ≥24 hours, or report of subjective fever lasting ≥24 hours); AND
- 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
- Subject (or legal authorized representative) capable of understanding and signing an informed consent form and assent form, when appropriate.
Exclusion Criteria:
- Female participants pregnant and/or lactating.
- Female participant has childbearing potential and is unwilling to use an acceptable method of birth control for the duration of the study.
- Participant has a significant co-morbid disease that by the Investigator's determination would make the participant unsuitable for enrollment, including unstable medical conditions.
- 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.
- 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.
- Known hypersensitivity to any of the formulation components of AT1001.
Sites / Locations
- Massachusetts General HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Placebo Comparator
Experimental
Placebo
Larazotide Acetate
Matching placebo will be administered orally four times a day (QID) to the standard of care for MIS-C.
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.