Randomised Evaluation of COVID-19 Therapy (RECOVERY) in Children With PIMS-TS in Switzerland (SWISSPED-RECOVERY)
NCT ID: NCT04826588
Last Updated: 2025-02-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
76 participants
INTERVENTIONAL
2021-05-23
2022-11-20
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
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.
TREATMENT
NONE
Study Groups
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Methylprednisolone sodium succinate 10 mg/kg
Methylprednisolone sodium succinate 10 mg/kg intravenously once daily for 3 days (max 1 g per dose)
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) 2g/kg intravenously as a single dose in line with guidance for dosing and administration in Kawasaki disease
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
Interventions
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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) 2g/kg intravenously as a single dose in line with guidance for dosing and administration in Kawasaki disease
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
44 Weeks
18 Years
ALL
No
Sponsors
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SwissPedNet
UNKNOWN
University Children's Hospital Basel
OTHER
Responsible Party
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Principal Investigators
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Julia Bielicki, Dr. med.
Role: PRINCIPAL_INVESTIGATOR
Paediatric Infectious Diseases and Vaccinology, Universität-Kinderspital beider Basel (UKBB)
Luregn Schlapbach, Dr. med.
Role: PRINCIPAL_INVESTIGATOR
Pediatric and Neonatal Intensive Care Unit, University Children's Hospital Zurich
Locations
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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
Countries
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References
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Welzel T, Atkinson A, Schobi N, Andre MC, Bailey DGN, Blanchard-Rohner G, Buettcher M, Grazioli S, Koehler H, Perez MH, Truck J, Vanoni F, Zimmermann P, Sanchez C, Bielicki JA, Schlapbach LJ; Swissped RECOVERY Trial Group. Methylprednisolone versus intravenous immunoglobulins in children with paediatric inflammatory multisystem syndrome temporally associated with SARS-CoV-2 (PIMS-TS): an open-label, multicentre, randomised trial. Lancet Child Adolesc Health. 2023 Apr;7(4):238-248. doi: 10.1016/S2352-4642(23)00020-2. Epub 2023 Feb 3.
Schobi N, Sanchez C, Welzel T, Bamford A, Webb K, Rojo P, Tremoulet A, Atkinson A, Schlapbach LJ, Bielicki JA; Swissped-RECOVERY trial group. Swissped-RECOVERY: masked independent adjudication for the interpretation of non-randomised treatment in a two-arm open-label randomised controlled trial (methylprednisolone vs immunoglobulins) in Paediatric Inflammatory Multisystem Syndrome Temporally Associated with SARS-CoV-2 (PIMS-TS) involving 10 secondary and tertiary paediatric hospitals in Switzerland. BMJ Open. 2024 Apr 25;14(4):e078137. doi: 10.1136/bmjopen-2023-078137.
Andre MC, Sanchez C, Bressieux-Degueldre S, Perez MH, Wutz D, Blanchard-Rohner G, Grazioli S, Schobi N, Truck J, Welzel T, Atkinson A, Schlapbach LJ, Bielicki J; Swissped RECOVERY Trial Group. Cardiac assessment and inflammatory markers in children with paediatric inflammatory multisystem syndrome temporally associated with SARS-CoV2 (PIMS-TS) treated with methylprednisolone versus intravenous immunoglobulins: 6-month follow-up outcomes of the randomised controlled Swissped RECOVERY trial. EClinicalMedicine. 2023 Dec 6;67:102358. doi: 10.1016/j.eclinm.2023.102358. eCollection 2024 Jan.
Welzel T, Schobi N, Andre MC, Bailey DGN, Blanchard-Rohner G, Buettcher M, Grazioli S, Koehler H, Perez MH, Truck J, Vanoni F, Zimmermann P, Atkinson A, Sanchez C, Whittaker E, Faust SN, Bielicki JA, Schlapbach LJ; Swissped Recovery Trial. Multicenter Randomized Trial of Methylprednisolone vs. Intravenous Immunoglobulins to Treat the Pediatric Inflammatory Multisystem Syndrome-Temporally Associated With SARS-CoV-2 (PIMS-TS): Protocol of the Swissped RECOVERY Trial. Front Pediatr. 2022 May 20;10:905046. doi: 10.3389/fped.2022.905046. eCollection 2022.
Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2021-00362; ks21Bielicki2
Identifier Type: -
Identifier Source: org_study_id
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