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

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ClinicalTrials.gov Identifier: NCT04826588
Recruitment Status : Recruiting
First Posted : April 1, 2021
Last Update Posted : June 18, 2021
Sponsor:
Information provided by (Responsible Party):
University Children's Hospital Basel

Brief 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 receiving standard of care. It is an adaptive pragmatic platform trial with an open-label randomisation.

For each pairwise comparison with the 'no additional treatment' arm, the primary objective is to provide reliable estimates of the effect of study treatments on the duration of hospital stay after randomisation. New trial arms can be added as evidence emerges that other candidate therapeutics should be evaluated.


Condition or disease Intervention/treatment Phase
Paediatric Inflammatory Multisystem Syndrome-Temporally Associated With SARS-CoV-2 (PIMS-TS) Drug: Methylprednisolone sodium succinate Biological: Human normal immunoglobulin (IVIg) Phase 3

Detailed Description:

In May 2020 a new COVID-associated inflammatory syndrome in children was identified, Paediatric Inflammatory Multisystem Syndrome - Temporally associated with SARS-CoV-2 (PIMS-TS). A rapid international consensus process identified the need to evaluate corticosteroids and intravenous immunoglobulin (IVIg) as initial therapies in PIMS-TS, and confirmed tocilizumab and anakinra as biological anti-inflammatory agents to be evaluated as a second line therapy.

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 receiving standard of care. It is an adaptive pragmatic platform trial with an open-label randomisation.

For each pairwise comparison with the 'no additional treatment' arm, the primary objective is to provide reliable estimates of the effect of study treatments on the duration of hospital stay after randomisation. New trial arms can be added as evidence emerges that other candidate therapeutics should be evaluated.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Overarching trial design with treatment arms that are both available at the hospital and not believed by the enrolling doctor to be contraindicated (e.g. by particular co-morbid conditions or concomitant medications). Treatment arms to be added or removed according to the emerging evidence.

Main randomisation part A: no additional treatment vs corticosteroids vs intravenous immunoglobulin.

Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomised Evaluation of COVID-19 Therapy (RECOVERY) in Children With PIMS-TS in Switzerland (SWISSPED-RECOVERY)
Actual Study Start Date : May 21, 2021
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : April 2022


Arm Intervention/treatment
Active Comparator: Methylprednisolone sodium succinate
Methylprednisolone sodium succinate 10 mg/kg intravenously once daily for 3 days (max 1 g per dose)
Drug: Methylprednisolone sodium succinate
Methylprednisolone sodium succinate 10 mg/kg intravenously once daily for 3 days (max 1 g per dose)

Active Comparator: 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
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

No Intervention: Standard of care
Patient receives usual hospital care



Primary Outcome Measures :
  1. Hospital length of stay [ Time Frame: Within 28 days after randomisation ]
    effect of study treatment on hospital length of stay


Secondary Outcome Measures :
  1. All-cause mortality among patients [ Time Frame: Within 28 days and up to 6 months after randomisation ]
    For each pairwise comparison with the 'no additional treatment' arm, the primary objective is to provide reliable estimates of the effect of study treatments on all-cause mortality.

  2. Composite endpoint of death or need for mechanical ventilation or extracorporeal membrane oxygenation (ECMO) [ Time Frame: Within 28 days and up to 6 months after randomisation ]
    Among patients not on invasive mechanical ventilation at baseline, the number of patients with a composite endpoint of death or need for invasive mechanical ventilation or ECMO.


Other Outcome Measures:
  1. Need for (and duration of) ventilation [ Time Frame: Within 28 days and up to 6 months after randomisation ]
    To assess the effects of study treatment on number of patients who needed any ventilation and (for invasive mechanical ventilation) the number of days it was required

  2. Need for renal replacement therapy [ Time Frame: Within 28 days and up to 6 months after randomisation ]
    To assess the effects of study treatment on number of patients who needed renal replacement therapy

  3. Number of patients who had thrombotic events [ Time Frame: Within 28 days and up to 6 months after randomisation ]
    To assess the effects of study treatment on number of patients who had thrombotic events

  4. Cardiac outcome (long-term impact) of PIMS-TS after discharge [ Time Frame: Post-discharge extended follow-up visits up to 6 months after randomisation ]
    Cardiac function and presence of coronary artery aneurysms will be assessed by echocardiography.

  5. Neurological outcome (long-term impact) of PIMS-TS after discharge [ Time Frame: Post-discharge extended follow-up visits up to 6 months after randomisation ]
    assessment of post-traumatic stress disorder

  6. Health care costs [ Time Frame: Within 28 days after randomisation ]
    Direct hospitalization-related costs will be captured for health economic analyses. For each PIMS-TS related hospitalization episode recruited in the study, the total Diagnosis-Related Group (DRG) costs claimed by the respective study site will be extracted from the institutional finance records, and analysed in batch upon completion of recruitment



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Ages Eligible for Study:   44 Weeks to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Hospitalised children (aged <18 years old)
  • 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:

  • Neonates/infants with a corrected gestational age of <= 44 weeks
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04826588


Contacts
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Contact: Julia Bielicki, Dr. med. +41 61 7041212 julia.bielicki@ukbb.ch
Contact: Tatjana Welzel, Dr.med. +41 61 704 2252 tatjana.welzel@ukbb.ch

Locations
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Switzerland
Cantonal Hospital Aarau, Department of Paediatrics Recruiting
Aarau, Switzerland, 5001
Contact: Henrik Köhler, Prof. Dr. med.         
Principal Investigator: Henrik Köhler, Prof. Dr. med.         
University of Basel Children's Hospital Recruiting
Basel, Switzerland, 4056
Contact: Julia Bielicki, Dr. med.    + 41 61 7041212    julia.bielicki@ukbb.ch   
Contact: Tatjana Welzel, Dr. med.    +41 61 704 2252    tatjana.welzel@ukbb.ch   
Principal Investigator: Maya André, PD Dr. med.         
Ente Ospedaliero Cantonale Ticino (EOC) Pediatrica Not yet recruiting
Bellinzona, Switzerland, 6500
Contact: Vanoni Vanoni, Dr. med.         
Principal Investigator: Federica Vanoni, Dr. med.         
Department of Pediatrics, University of Bern Not yet recruiting
Bern, Switzerland, 3010
Contact: Nina Schoebi, Dr. med.         
Principal Investigator: Nina Schoebi, Dr. med.         
Department of Child, Woman and, Adolescent Medecine, Geneva University Hospitals and Faculty of Medicine Not yet recruiting
Geneva, Switzerland
Contact: Serge Grazioli, Dr. med.         
Principal Investigator: Serge Grazioli, Dr. med.         
Department of Pediatrics,University Hospital of Lausanne (CHUV) Not yet recruiting
Lausanne, Switzerland
Contact: Marie-Helene Perez, Dr. med.         
Principal Investigator: Marie-Helene Perez, Dr. med.         
Department of Pediatrics, Cantonal Hospital Luzern Recruiting
Luzern 16, Switzerland, 6000
Contact: Michael Buettcher, Dr. med.         
Principal Investigator: Michael Buettcher, Dr. med.         
Children's Hospital of Eastern Switzerland Not yet recruiting
St. Gallen, Switzerland, 9006
Contact: Douggl GN Bailey, Dr. med. univ.    +41 71 243 13 77      
Principal Investigator: Douggl GN Bailey, Dr. med. univ.         
Department of Pediatrics, Cantonal Hospital Fribourg Not yet recruiting
Villars-sur-Glâne, Switzerland, 1752
Contact: Petra Zimmermann, Dr. med.         
Principal Investigator: Petra Zimmermann, Dr. med.         
University Children's Hospital Zuerich Not yet recruiting
Zuerich, Switzerland, 8032
Contact: Johannes Trueck, PD Dr. med.         
Principal Investigator: Johannes Trueck, PD Dr. med.         
Sponsors and Collaborators
University Children's Hospital Basel
Investigators
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Principal Investigator: Julia Bielicki, Dr. med. Paediatric Infectious Diseases and Vaccinology, Universität-Kinderspital beider Basel (UKBB)
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Responsible Party: University Children's Hospital Basel
ClinicalTrials.gov Identifier: NCT04826588    
Other Study ID Numbers: 2021-00362; ks21Bielicki2
First Posted: April 1, 2021    Key Record Dates
Last Update Posted: June 18, 2021
Last Verified: June 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Children's Hospital Basel:
coronavirus-disease (COVID-19)
SARS coronavirus 2 (SARS-CoV-2)
tocilizumab
anakinra
Human normal immunoglobulin (IVIg)
Methylprednisolone sodium succinate
Additional relevant MeSH terms:
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Methylprednisolone
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Immunoglobulins
Immunoglobulins, Intravenous
Antibodies
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Protective Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Immunologic Factors