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Trial - NCT04826588


Column Value
Trial registration number NCT04826588
Full text link
Last imported at : April 6, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04826588

First author
Last imported at : Sept. 1, 2022, 10 p.m.
Source : ClinicalTrials.gov

Julia Bielicki, Dr. med;Luregn Schlapbach, Dr. med.

Contact
Last imported at : Sept. 1, 2022, 10 p.m.
Source : ClinicalTrials.gov

Not reported

Registration date
Last imported at : April 6, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

2021-04-01

Recruitment status
Last imported at : Jan. 20, 2023, 8 a.m.
Source : ClinicalTrials.gov

Completed

Study design
Last imported at : April 6, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : April 6, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : April 6, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : April 6, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Open label

Center
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov

multi-center

Study aim
Last imported at : April 6, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Treatment

Inclusion criteria
Last imported at : April 6, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

inclusion criteria: - hospitalised children (aged <18 years old) - sars-cov-2 infection associated disease (clinically suspected or laboratory confirmed) with evidence of single or multi-organ dysfunction (called pediatric multisystem inflammatory syndrome temporally associated with covid-19 [pims-ts]). - no medical history that might, in the opinion of the attending clinician, put the patient at significant risk if he/she were to participate in the trial

Exclusion criteria
Last imported at : April 6, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

- neonates/infants with a corrected gestational age of <= 44 weeks - if the attending clinician believes that there is a specific contra-indication to one of the active drug treatment arms or that the patient should definitely be receiving one of the active drug treatment arms, then that arm will not be available for randomisation for that patient.

Number of arms
Last imported at : April 6, 2022, 9 p.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : April 6, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

University Children's Hospital Basel

Inclusion age min
Last imported at : April 6, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

0

Inclusion age max
Last imported at : April 6, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

18

Countries
Last imported at : April 6, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Switzerland

Type of patients
Last imported at : April 6, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

No restriction on type of patients

Severity scale
Last imported at : April 6, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

0: No restriction on type of patients

Total sample size
Last imported at : Sept. 1, 2022, 10 p.m.
Source : ClinicalTrials.gov

76

primary outcome
Last imported at : April 6, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Hospital length of stay

Notes
Last imported at : April 6, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : April 6, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Phase 3

Arms
Last imported at : April 6, 2022, 9 p.m.
Source : ClinicalTrials.gov

[{"arm_notes": "nan", "treatment_id": 798, "treatment_name": "Methylprednisolone", "treatment_type": "Corticosteroids", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "nan", "treatment_id": 597, "treatment_name": "Human immunoglobulin", "treatment_type": "Immunoglobulins", "pharmacological_treatment": "Pharmacological treatment"}]