NCT04826588

Randomised Evaluation of COVID-19 Therapy (RECOVERY) in Children With PIMS-TS in Switzerland (SWISSPED-RECOVERY)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 76 (actual)
• Sponsor: University Children's Hospital Basel · Academic / Other
• Sex: All
• Age: 44 Weeks – 18 Years
• Healthy volunteers: Not accepted

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 provide reliable evidence on the efficacy of candidate therapies for children hospitalised with PIMS-TS. It is an adaptive pragmatic platform trial with an open-label randomisation. New trial arms can be added as evidence emerges that other candidate therapeutics should be evaluated.

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 international consensus process identified the need to evaluate corticosteroids and intravenous immunoglobulin (IVIg) as initial therapies in PIMS-TS, and confirmed tocilizumab and anakinra as biological anti-inflammatory agents to be evaluated as a second line therapy. This Swissped-Recovery trial is a sister trial to the RECOVERY international trial with the implementation of the study at Swiss study sites. The protocol describes an overarching trial design to provide reliable evidence on the efficacy of candidate therapies for children hospitalised with PIMS-TS. It is an adaptive pragmatic platform trial with an open-label randomisation. New trial arms can be added as evidence emerges that other candidate therapeutics should be evaluated. Additional substudies can be added to provide more detailed information on side effects or sub-categorisation of patient types.

Conditions

• Paediatric Inflammatory Multisystem Syndrome-Temporally Associated With SARS-CoV-2 (PIMS-TS)

Interventions

Type	Name	Description
DRUG	Methylprednisolone sodium succinate 10 mg/kg intravenously	Methylprednisolone sodium succinate 10 mg/kg intravenously once daily for 3 days (max 1 g per dose)
BIOLOGICAL	Human normal immunoglobulin (IVIg)	Human normal immunoglobulin (IVIg) 2g/kg intravenously as a single dose in line with guidance for dosing and administration in Kawasaki disease

Timeline

• Start date: 2021-05-23
• Primary completion: 2022-11-20
• Completion: 2022-11-20
• First posted: 2021-04-01
• Last updated: 2025-02-13

Locations

10 sites across 1 country: Switzerland