Randomised Evaluation of COVID-19 Therapy (RECOVERY) in Children With PIMS-TS in Switzerland (SWISSPED-RECOVERY)
Condition: Paediatric Inflammatory Multisystem Syndrome-Temporally Associated With SARS-CoV-2 (PIMS-TS)
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 3

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.
    

Intervention name(s): Methylprednisolone sodium succinate 10 mg/kg intravenously; Human normal immunoglobulin (IVIg)
Intervention type(s): Drug; Biological
Intervention description(s): Methylprednisolone sodium succinate 10 mg/kg intravenously once daily for 3 days (max 1 g per dose); Human normal immunoglobulin (IVIg) 2g/kg intravenously as a single dose in line with guidance for dosing and administration in Kawasaki disease
Intervention MeSH terms: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Immunoglobulins
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Overarching trial design with treatment arms that are both available at the hospital and not believed by the enrolling doctor to be contraindicated (e.g. by particular co-morbid conditions or concomitant medications). Treatment arms to be added or removed according to the emerging evidence.
Main randomisation part A: Methylprednisolone 2 mg/kg for three days intravenous or orally vs corticosteroids methylprednisolone 10mg/kg intravenous for three days vs intravenous immunoglobulin.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: coronavirus-disease (COVID-19); SARS coronavirus 2 (SARS-CoV-2); tocilizumab; anakinra; Human normal immunoglobulin (IVIg); Methylprednisolone sodium succinate