Multisystem Inflammatory Syndrome in Children (MIS-C) Associated With Coronavirus Disease (COVID-19) Clinical Trial
Official title:
Intermediate-size Expanded Access of Remestemcel-L, Human Mesenchymal Stromal Cells, for Multisystem Inflammatory Syndrome in Children (MIS-C) Associated With Coronavirus Disease (COVID-19)
| NCT number | NCT04456439 |
| Other study ID # | MSB-MSC-MISC001 |
| Secondary ID | |
| Status | Available |
| Phase | |
| First received | |
| Last updated |
The objectives of this intermediate-size expanded access protocol are to assess the safety and efficacy of remestemcel-L in participants with MIS-C associated with COVID-19.
| Status | Available |
| Enrollment | 0 |
| Est. completion date | |
| Est. primary completion date | |
| Accepts healthy volunteers | |
| Gender | All |
| Age group | 2 Months to 17 Years |
| Eligibility | Inclusion Criteria 1. 2 months to 17 years of age, inclusive 2. Positive for current or recent SARS-CoV-2 (COVID-19) infection by real-time reverse transcription polymerase chain reaction (RT-PCR), serology, or antigen test; or COVID-19 exposure within the 4 weeks prior to the onset of symptoms AND no alternative plausible diagnoses 3. Presenting with: - Fever (>38.0°C or >100.4°F for =24 hours) or reporting subjective fever lasting =24 hours - Laboratory evidence of inflammation with high sensitivity C-reactive protein (hsCRP) =4.0 milligrams per deciliter (mg/dL) and associated abnormalities of at least one of the following: - elevated erythrocyte sedimentation rate (ESR) - elevated fibrinogen - elevated procalcitonin - elevated d-dimer - elevated ferritin - elevated lactic dehydrogenase (LDH) - elevated interleukin 6 (IL-6) - elevated neutrophils - reduced lymphocytes - low albumin - Clinically severe multisystem illness requiring hospitalization with evidence for cardiac involvement plus at least one other organ involvement (renal, respiratory, hematologic, gastrointestinal, dermatologic or neurological) - Cardiac involvement is defined as reduced left ventricular ejection fraction (<55%) in addition to at least one of the following: - increased troponin I, - increased N-terminal pro-B-type natriuretic peptide (NT-proBNP) or BNP and/or - echocardiographic and/or other imaging evidence of left anterior descending coronary artery (LAD) and/or right coronary artery (RCA) dilation associated with a z-score > 2.5 4. If on mechanical ventilation or ECMO, =72 hours post initiation of the respiratory support device Exclusion Criteria 1. Documented other microbial cause for MIS-C including bacterial sepsis, staphylococcal or streptococcal shock syndromes, or infections associated with myocarditis such as enterovirus. Of importance, waiting for results of these investigations should not delay initiation of remestemcel-L therapy. 2. Females who are pregnant or lactating 3. Body mass index (BMI) =40 kilograms per square meter (kg/m^2) 4. Known hypersensitivity to dimethyl sulfoxide (DMSO) or to porcine or bovine proteins 5. Aspartate aminotransferase/alanine transaminase (AST/ALT) =5x upper limit of normal (ULN) 6. Creatinine clearance <30 mL/min 7. Serum creatinine >2 mg/dL 8. Any end-stage organ disease which in the opinion of the treating physician may possibly affect the safety of the remestemcel-L treatment. |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Mesoblast International Sàrl |
Eckard AR, Borow KM, Mack EH, Burke E, Atz AM. Remestemcel-L Therapy for COVID-19-Associated Multisystem Inflammatory Syndrome in Children. Pediatrics. 2021 May;147(5):e2020046573. doi: 10.1542/peds.2020-046573. Epub 2021 Feb 12. — View Citation