Skip to main content
OpenTrials
Completed

NCT Number: NCT04826588

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

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. 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Paediatric Inflammatory Multisystem Syndrome-Temporally Associated With SARS-CoV-2 (PIMS-TS) COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases pediatric multisystem inflammatory disease, COVID-19 related

Age range

44 week–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Cantonal Hospital Aarau, Department of Paediatrics, Aarau, Switzerland

Loading trial locations.

About this study

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. 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Methylprednisolone sodium succinate 10 mg/kg intravenously

Drug

Methylprednisolone sodium succinate 10 mg/kg intravenously once daily for 3 days (max 1 g per dose)

Human normal immunoglobulin (IVIg)

Biological

Human normal immunoglobulin (IVIg) 2g/kg intravenously as a single dose in line with guidance for dosing and administration in Kawasaki disease

Primary outcomes

  1. Hospital length of stay

    Time frame: Within 28 days after randomisation

    effect of study treatment on hospital length of stay

Secondary outcomes

  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 outcomes

  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

  7. Quality of life post-infection assessed by Strengths and Difficulties Questionnaire (SDQ)

    Time frame: Post-discharge extended follow-up visits up to 6 months after randomisation

    The strengths and difficulties questionnaire (SDQ) is a short behavioural screening questionnaire for children aged 3 to 16. The 25 personality attributes in the SDQ are made up of 5 scales of 5 items each. The scales are:

    Emotional symptoms, Conduct problems, Hyperactivity/inattention, Peer relationship problems, Prosocial behaviour. Each subscale includes five items, rating each item as either: Never = 0, Somewhat True = 1 or Certainly True = 2. SDQ total scores of 17 and above are considered to be abnormal.

Sponsors and collaborators

Lead sponsor

University Children's Hospital Basel

Other

Collaborators

  • SwissPedNet

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 1, 2021
Registry last updated
Feb 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.