Status:
COMPLETED
MIS-C Comparative Effectiveness Study
Lead Sponsor:
University of California, San Diego
Collaborating Sponsors:
Children's Hospital of Michigan
Conditions:
Multisystem Inflammatory Syndrome-Children
Eligibility:
All Genders
Up to 20 years
Phase:
PHASE2
PHASE3
Brief Summary
In March 2020, children exposed to the virus that causes the COVID-19 illness, SARS-CoV-2, presented with fever and significant inflammation about a month after exposure to the virus. Some children we...
Detailed Description
This study is a multi-site, randomized, pragmatic, comparative effectiveness study of children with MIS-C. The current standard of care is that all MIS-C patients are initially treated with IVIG and r...
Eligibility Criteria
Inclusion
- An individual aged \<21 years presenting with
- Fever (\>38.0°C for ≥24 hours; may be by subjective report) AND
- Two or more of the following (from two different systems; e.g. one from cardiac and one from mucocutaneous):
- Cardiac
- Hypotension
- Shock
- Arrhythmia
- Tachycardia
- Left ventricular ejection fraction \<55%
- Valvulitis
- Coronary artery enlargement (LAD or RCA Z-score ≥ 2.5)
- Pericardial effusion Gastrointestinal
- Diarrhea
- Nausea/vomiting
- Significant abdominal pain Immunologic
- Lymphadenopathy (unilateral cervical or diffuse) Mucocutaneous
- Bilateral conjunctival injection
- Extremity swelling or erythema
- Rash
- Lip erythema/Strawberry tongue Neurologic
- Altered mental status
- Focal neurological deficits
- Headache
- Meningismus
- Laboratory evidence of inflammation, including but not limited to, an elevated C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), fibrinogen, procalcitonin, D-dimer, ferritin, lactic acid dehydrogenase (LDH), neutrophilia, lymphopenia or hypoalbuminemia AND
- No alternative plausible diagnoses based on clinical judgement AND
- Positive for current or recent SARS-CoV-2 infection by RT-PCR, serology, or antigen test; or suspected COVID-19 exposure AND
- Parent or legal guardian (or self if at least 18 years old) able and willing to provide informed consent and subject willing and able to provide assent when appropriate.
Exclusion
- Known immunodeficiency
- Pre-existing medical condition that precludes receiving one or more of the study medications (e.g. TB, drug allergy to study medication).
Key Trial Info
Start Date :
December 22 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 25 2024
Estimated Enrollment :
73 Patients enrolled
Trial Details
Trial ID
NCT04898231
Start Date
December 22 2020
End Date
April 25 2024
Last Update
November 4 2025
Active Locations (2)
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1
Rady Children's Hospital
San Diego, California, United States, 92123
2
Children's Hospital Michigan
Detroit, Michigan, United States, 48201