AUTHOR=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. ,  the Swissped Recovery Trial 

TITLE=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

JOURNAL=Frontiers in Pediatrics

VOLUME=Volume 10 - 2022

YEAR=2022

URL=https://www.frontiersin.org/journals/pediatrics/articles/10.3389/fped.2022.905046

DOI=10.3389/fped.2022.905046

ISSN=2296-2360

ABSTRACT=Introduction: In 2020, a new disease entitled Paediatric 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 three 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 versus 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 clinicaltrial.gov (NCT 04826588).