Status:
COMPLETED
Randomised Evaluation of COVID-19 Therapy (RECOVERY) in Children With PIMS-TS in Switzerland (SWISSPED-RECOVERY)
Lead Sponsor:
University Children's Hospital Basel
Collaborating Sponsors:
SwissPedNet
Conditions:
Paediatric Inflammatory Multisystem Syndrome-Temporally Associated With SARS-CoV-2 (PIMS-TS)
Eligibility:
All Genders
44-18 years
Phase:
PHASE3
Brief Summary
The study is to provide reliable estimates of the effect of study treatment on hospital length of stay through to 28 days after randomisation. The protocol describes an overarching trial design to pr...
Detailed Description
In May 2020 a new COVID-associated inflammatory syndrome in children was identified, Paediatric Inflammatory Multisystem Syndrome - Temporally associated with SARS-CoV-2 (PIMS-TS). A rapid internation...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 23 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 20 2022
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT04826588
Start Date
May 23 2021
End Date
November 20 2022
Last Update
February 13 2025
Active Locations (10)
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1
Cantonal Hospital Aarau, Department of Paediatrics
Aarau, Switzerland, 5001
2
University of Basel Children's Hospital
Basel, Switzerland, 4056
3
Ente Ospedaliero Cantonale Ticino (EOC) Pediatrica
Bellinzona, Switzerland, 6500
4
Department of Pediatrics, University of Bern
Bern, Switzerland, 3010