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

Phase 3

Completed

• Conditions: Paediatric Inflammatory Multisystem Syndrome-Temporally Associated With SARS-CoV-2 (PIMS-TS)
• Interventions: Drug: Methylprednisolone sodium succinate 10 mg/kg intravenously; Biological: Human normal immunoglobulin (IVIg)

• Registration Number: NCT04826588
• Lead Sponsor: University Children's Hospital Basel

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 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.

Study Timeline

• Study First Submitted: 2021-03-31
• Study First Submitted QC: 2021-03-31
• Study First Posted: 2021-04-01
• Study Start: 2021-05-23
• Primary Completion: 2022-11-20
• Study Completion: 2022-11-20
• Status Verified: 2023-02
• Last Update Submitted: 2025-02-11
• Last Update Posted: 2025-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

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

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Methylprednisolone sodium succinate 10 mg/kg	Methylprednisolone sodium succinate 10 mg/kg intravenously	Methylprednisolone sodium succinate 10 mg/kg intravenously once daily for 3 days (max 1 g per dose)
Human normal immunoglobulin (IVIg)	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

Primary Outcome Measures

Name	Time	Method
Hospital length of stay	Within 28 days after randomisation	effect of study treatment on hospital length of stay

Secondary Outcome Measures

Name	Time	Method
All-cause mortality among patients	Within 28 days and up to 6 months after randomisation	For each pairwise comparison with the 'no additional treatment' arm, the primary objective is to provide reliable estimates of the effect of study treatments on all-cause mortality.
Composite endpoint of death or need for mechanical ventilation or extracorporeal membrane oxygenation (ECMO)	Within 28 days and up to 6 months after randomisation	Among patients not on invasive mechanical ventilation at baseline, the number of patients with a composite endpoint of death or need for invasive mechanical ventilation or ECMO.

Trial Locations

Locations (10)

Department of Pediatrics,University Hospital of Lausanne (CHUV); 🇨🇭 Lausanne, Switzerland

University of Basel Children's Hospital; 🇨🇭 Basel, Switzerland

Ente Ospedaliero Cantonale Ticino (EOC) Pediatrica; 🇨🇭 Bellinzona, Switzerland

Department of Pediatrics, Cantonal Hospital Luzern; 🇨🇭 Luzern 16, Switzerland

University Children's Hospital Zuerich; 🇨🇭 Zuerich, Switzerland

Department of Child, Woman and, Adolescent Medecine, Geneva University Hospitals and Faculty of Medicine; 🇨🇭 Geneva, Switzerland

Department of Pediatrics, Cantonal Hospital Fribourg; 🇨🇭 Villars-sur-Glâne, Switzerland

Children's Hospital of Eastern Switzerland; 🇨🇭 St. Gallen, Switzerland

Cantonal Hospital Aarau, Department of Paediatrics; 🇨🇭 Aarau, Switzerland

Department of Pediatrics, University of Bern; 🇨🇭 Bern, Switzerland