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| Column | Value |
|---|---|
| Trial registration number | NCT04898231 |
|
Full text link
Last imported at : Nov. 16, 2021, 6:30 p.m. Source : ClinicalTrials.gov |
|
|
First author
Last imported at : May 18, 2023, midnight Source : ClinicalTrials.gov |
|
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Contact
Last imported at : May 18, 2023, midnight Source : ClinicalTrials.gov |
Not reported |
|
Registration date
Last imported at : Nov. 16, 2021, 6:30 p.m. Source : ClinicalTrials.gov |
2021-05-24 |
|
Recruitment status
Last imported at : May 18, 2023, midnight Source : ClinicalTrials.gov |
Not recruiting |
|
Study design
Last imported at : Nov. 16, 2021, 6:30 p.m. Source : ClinicalTrials.gov |
RCT |
|
Allocation
Last imported at : Nov. 16, 2021, 6:30 p.m. Source : ClinicalTrials.gov |
Randomized |
|
Design
Last imported at : Nov. 16, 2021, 6:30 p.m. Source : ClinicalTrials.gov |
Parallel |
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Masking
Last imported at : Nov. 16, 2021, 6:30 p.m. Source : ClinicalTrials.gov |
Open label |
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Center
Last imported at : April 7, 2022, 9:30 p.m. Source : ClinicalTrials.gov |
multi-center |
|
Study aim
Last imported at : Nov. 16, 2021, 6:30 p.m. Source : ClinicalTrials.gov |
Treatment |
|
Inclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m. Source : ClinicalTrials.gov |
inclusion criteria: 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 criteria
Last imported at : Nov. 16, 2021, 6:30 p.m. Source : ClinicalTrials.gov |
known immunodeficiency pre-existing medical condition that precludes receiving one or more of the study medications (e.g. tb, drug allergy to study medication). |
|
Number of arms
Last imported at : Nov. 16, 2021, 6:30 p.m. Source : ClinicalTrials.gov |
3 |
|
Funding
Last imported at : Nov. 16, 2021, 6:30 p.m. Source : ClinicalTrials.gov |
University of California, San Diego |
|
Inclusion age min
Last imported at : Nov. 16, 2021, 6:30 p.m. Source : ClinicalTrials.gov |
2 |
|
Inclusion age max
Last imported at : Nov. 16, 2021, 6:30 p.m. Source : ClinicalTrials.gov |
21 |
|
Countries
Last imported at : Nov. 16, 2021, 6:30 p.m. Source : ClinicalTrials.gov |
United States |
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Type of patients
Last imported at : Nov. 16, 2021, 6:30 p.m. Source : ClinicalTrials.gov |
No restriction on type of patients |
|
Severity scale
Last imported at : Nov. 16, 2021, 6:30 p.m. Source : ClinicalTrials.gov |
0: No restriction on type of patients |
|
Total sample size
Last imported at : Nov. 16, 2021, 6:30 p.m. Source : ClinicalTrials.gov |
180 |
|
primary outcome
Last imported at : Nov. 16, 2021, 6:30 p.m. Source : ClinicalTrials.gov |
Anti-inflammatory treatment regimen lowest rate of second randomization |
|
Notes
Last imported at : Nov. 16, 2021, 6:30 p.m. Source : ClinicalTrials.gov |
None |
|
Phase
Last imported at : Nov. 16, 2021, 6:30 p.m. Source : ClinicalTrials.gov |
Phase 2/Phase 3 |
|
Arms
Last imported at : Nov. 16, 2021, 6:30 p.m. Source : ClinicalTrials.gov |
[{"arm_notes": "", "treatment_id": 83, "treatment_name": "Anakinra", "treatment_type": "Interleukin inhibitors", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 650, "treatment_name": "Infliximab", "treatment_type": "Other targeted therapies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 798, "treatment_name": "Methylprednisolone", "treatment_type": "Corticosteroids", "pharmacological_treatment": "Pharmacological treatment"}] |