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

NCT04826588 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2025-02-13

No results posted yet for this study

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.

Conditions

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

Interventions

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

Sponsors & Collaborators

  • SwissPedNet

    collaborator UNKNOWN

  • University Children's Hospital Basel

    lead OTHER

Principal Investigators

  • Julia Bielicki, Dr. med. · Paediatric Infectious Diseases and Vaccinology, Universität-Kinderspital beider Basel (UKBB)

  • Luregn Schlapbach, Dr. med. · Pediatric and Neonatal Intensive Care Unit, University Children's Hospital Zurich

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
44 Weeks
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-23
Primary Completion
2022-11-20
Completion
2022-11-20

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04826588 on ClinicalTrials.gov