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

被引：9

作者：

Welzel, Tatjana ^{[1
,2
,3
]}

Schobi, Nina ^{[4
]}

Andre, Maya C. ^{[5
,6
]}

Bailey, Douggl G. N. ^{[7
]}

Blanchard-Rohner, Geraldine ^{[8
]}

Buettcher, Michael ^{[2
,9
]}

Grazioli, Serge ^{[10
]}

Koehler, Henrik ^{[11
]}

Perez, Marie-Helene ^{[12
]}

Truck, Johannes ^{[13
]}

Vanoni, Federica ^{[14
,15
]}

Zimmermann, Petra ^{[16
,17
,18
]}

Atkinson, Andrew ^{[1
]}

Sanchez, Carlos ^{[1
]}

Whittaker, Elizabeth ^{[19
,20
]}

Faust, Saul N. ^{[21
,22
]}

Bielicki, Julia A. ^{[1
,23
]}

Schlapbach, Luregn J. ^{[24
,25
]}

机构：

[1] Univ Basel, Univ Childrens Hosp Basel, Paediat Res Ctr, Basel, Switzerland

[2] Univ Basel, Univ Childrens Hosp Basel, Paediat Pharmacol & Pharmacometr, Basel, Switzerland

[3] Univ Basel, Univ Childrens Hosp Basel, Div Paediat Rheumatol, Basel, Switzerland

[4] Univ Bern, Bern Univ Hosp, Dept Paediat, Div Paediat Infect Dis, Bern, Switzerland

[5] Univ Basel, Univ Childrens Hosp Basel, Div Resp & Crit Care Med, Basel, Switzerland

[6] Eberhard Karls Univ Tubingen, Univ Childrens Hosp, Dept Paediat Hematol & Oncol, Tubingen, Germany

[7] Childrens Hosp Eastern Switzerland, Paediat & Neonatal Intens Care Unit, St Gallen, Switzerland

[8] Geneva Univ Hosp, Fac Med, Dept Child, Div Gen Paediat, Geneva, Switzerland

[9] Cantonal Hosp Lucerne, Dept Paediat, Paediat Infect Dis Unit, Luzern, Switzerland

[10] Geneva Univ Hosp, Fac Med, Dept Child, Div Neonatal & Paediat Intens Care, Geneva, Switzerland

[11] Cantonal Hosp Aarau, Dept Paediat, Aarau, Switzerland

[12] Univ Hosp Lausanne, Paediat Intens Care Unit, Lausanne, Switzerland

[13] Univ Zurich UZH, Univ Childrens Hosp Zurich, Childrens Res Ctr, Div Immunol, Zurich, Switzerland

[14] Ente Ospedaliero Cantonale EOC, Paediat Inst Southern Switzerland, Clin Paediat, Bellinzona, Switzerland

[15] Univ Svizzera italiana, Fac Biomed Sci, Lugano, Switzerland

[16] Univ Fribourg, Fac Sci & Med, Dept Community Hlth, Fribourg, Switzerland

[17] Fribourg Hosp, Dept Paediat, Fribourg, Switzerland

[18] Murdoch Childrens Res Inst, Infect Dis Res Grp, Parkville, Vic, Australia

[19] Imperial Coll London, Sect Paediat Infect Dis, London, England

[20] Imperial Coll Healthcare NHS Trust, Dept Paediat Infect Dis, London, England

[21] Univ Hosp Southampton NHS Fdn Trust, NIHR Southampton Clin Res Facil & Biomed Res Ctr, Southampton, Hants, England

[22] Univ Southampton, Inst Life Sci, Fac Med, Southampton, Hants, England

[23] St Georges Univ, Ctr Neonatal & Paediat Infect, London, England

[24] Univ Childrens Hosp Zurich, Childrens Res Ctr, Dept Intens Care & Neonatol, Zurich, Switzerland

[25] Univ Queensland, Queensland Childrens Hosp, Child Hlth Res Ctr, Paediat Intens Care Unit, Brisbane, Qld, Australia

来源：

FRONTIERS IN PEDIATRICS | 2022年 / 10卷

关键词：

children; COVID-19; SARS-CoV-2; mortality; MIS-C; quality of life; treatment; trial; KAWASAKI-DISEASE; DIAGNOSIS;

D O I：

10.3389/fped.2022.905046

中图分类号：

R72 [儿科学];

学科分类号：

100202 ;

摘要：

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 similar to 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).

引用

页数：12

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