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

University Children's Hospital Basel76 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Eligibility

Sex: ALLMin age: 44 WeeksMax age: 18 Years

Medical Language ↔ Plain English

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.

Locations (10)

Cantonal Hospital Aarau, Department of Paediatrics

Aarau, Switzerland

University of Basel Children's Hospital

Basel, Switzerland

Ente Ospedaliero Cantonale Ticino (EOC) Pediatrica

Bellinzona, Switzerland

Department of Pediatrics, University of Bern

Bern, Switzerland

Department of Child, Woman and, Adolescent Medecine, Geneva University Hospitals and Faculty of Medicine

Geneva, Switzerland

Department of Pediatrics,University Hospital of Lausanne (CHUV)

Lausanne, Switzerland

Department of Pediatrics, Cantonal Hospital Luzern

Lucerne, Switzerland

Children's Hospital of Eastern Switzerland

Sankt Gallen, Switzerland

Department of Pediatrics, Cantonal Hospital Fribourg

Villars-sur-Glâne, Switzerland

University Children's Hospital Zuerich

Zurich, Switzerland

Outcomes

Primary Outcomes

Hospital length of stay

effect of study treatment on hospital length of stay

Time frame: Within 28 days after randomisation

Secondary Outcomes

All-cause mortality among patients

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.

Time frame: Within 28 days and up to 6 months after randomisation

Composite endpoint of death or need for mechanical ventilation or extracorporeal membrane oxygenation (ECMO)

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.