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.

Welzel, Tatjana; Schöbi, Nina; André, Maya C; Bailey, Douggl G N; Blanchard-Rohner, Geraldine; Buettcher, Michael; Grazioli, Serge; Koehler, Henrik; Perez, Marie-Helene; Trück, Johannes; Vanoni, Federica; Zimmermann, Petra; Atkinson, Andrew; Sanchez, Carlos; Whittaker, Elizabeth; Faust, Saul N; Bielicki, Julia A; Schlapbach, Luregn J (2022). 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. Frontiers in Pediatrics, 10, p. 905046. Frontiers 10.3389/fped.2022.905046

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Introduction

In 2020, a new disease entitled Pediatric Inflammatory Multisystem Syndrome temporally associated with COVID-19 (PIMS-TS), or Multisystem Inflammatory Syndrome in Children (MIS-C), emerged, with thousands of children affected globally. There is no available evidence based on randomized controlled trials (RCT) to date on the two most commonly used immunomodulatory treatments, intravenous immunoglobulins (IVIG) and corticosteroids. Therefore, the Swissped RECOVERY trial was conducted to assess whether intravenous (IV) methylprednisolone shortens hospital length of stay compared with IVIG.

Methods and Analysis

Swissped RECOVERY is an ongoing investigator-initiated, open-label, multicenter two-arm RCT in children and adolescents <18 years hospitalized with a diagnosis of PIMS-TS. The trial is recruiting at 10 sites across Switzerland. Patients diagnosed with PIMS-TS are randomized 1:1 to methylprednisolone IV (10 mg/kg/day for 3 days) or IVIG (2 g/kg as a single dose). The primary outcome is hospital length of stay censored at day 28, death, or discharge (whichever is first). The target total sample size is ~80 patients 1:1 randomized to each study arm. Ancillary and exploratory studies on inflammation, vaccination acceptance and coverage, long-term outcomes, and healthcare costs are pre-planned.

Significance

Currently, robust trial evidence for the treatment of PIMS-TS is lacking, with a controversy surrounding the use of corticosteroids vs. IVIG. This trial will provide evidence for the effectiveness and safety of these two treatments.

Ethics and Dissemination

The study protocol, which was designed based on the U.K. RECOVERY trial, the patient information and consent forms, and other study-specific study documents were approved by the local ethics committees (Project ID: 2021-00362).

Registration Details

The study is registered on the Swiss National Clinical Trials Portal (SNCTP000004720) and Clinicaltrials.gov (NCT04826588).

Item Type:

Journal Article (Further Contribution)

Division/Institute:

04 Faculty of Medicine > Department of Gynaecology, Paediatrics and Endocrinology (DFKE) > Clinic of Paediatric Medicine
04 Faculty of Medicine > Department of Gynaecology, Paediatrics and Endocrinology (DFKE) > Clinic of Paediatric Medicine > Paediatric Infectiology

UniBE Contributor:

Schöbi, Nina

Subjects:

600 Technology > 610 Medicine & health

ISSN:

2296-2360

Publisher:

Frontiers

Language:

English

Submitter:

Anette van Dorland

Date Deposited:

08 Jun 2022 10:40

Last Modified:

20 Jul 2022 16:16

Publisher DOI:

10.3389/fped.2022.905046

PubMed ID:

35669398

Uncontrolled Keywords:

COVID-19 MIS-C SARS-CoV-2 children mortality quality of life treatment trial

BORIS DOI:

10.48350/170506

URI:

https://boris.unibe.ch/id/eprint/170506

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