Paediatric Inflammatory Multisystem Syndrome-Temporally Associated With SARS-CoV-2 (PIMS-TS) Clinical Trial
Official title:
Randomised Evaluation of COVID-19 Therapy (RECOVERY) in Children With PIMS-TS in Switzerland (SWISSPED-RECOVERY)
| Verified date | February 2023 |
| Source | University Children's Hospital Basel |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 76 |
| Est. completion date | November 20, 2022 |
| Est. primary completion date | November 20, 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 44 Weeks to 18 Years |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| Switzerland | Cantonal Hospital Aarau, Department of Paediatrics | Aarau | |
| Switzerland | University of Basel Children's Hospital | Basel | |
| Switzerland | Ente Ospedaliero Cantonale Ticino (EOC) Pediatrica | Bellinzona | |
| Switzerland | Department of Pediatrics, University of Bern | Bern | |
| Switzerland | Department of Child, Woman and, Adolescent Medecine, Geneva University Hospitals and Faculty of Medicine | Geneva | |
| Switzerland | Department of Pediatrics,University Hospital of Lausanne (CHUV) | Lausanne | |
| Switzerland | Department of Pediatrics, Cantonal Hospital Luzern | Luzern 16 | |
| Switzerland | Children's Hospital of Eastern Switzerland | St. Gallen | |
| Switzerland | Department of Pediatrics, Cantonal Hospital Fribourg | Villars-sur-Glâne | |
| Switzerland | University Children's Hospital Zuerich | Zuerich |
| Lead Sponsor | Collaborator |
|---|---|
| University Children's Hospital Basel |
Switzerland,
Welzel T, Atkinson A, Schobi N, Andre MC, Bailey DGN, Blanchard-Rohner G, Buettcher M, Grazioli S, Koehler H, Perez MH, Truck J, Vanoni F, Zimmermann P, Sanchez C, Bielicki JA, Schlapbach LJ; Swissped RECOVERY Trial Group. Methylprednisolone versus intrav — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Need for (and duration of) ventilation | 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 | Within 28 days and up to 6 months after randomisation | |
| Other | Need for renal replacement therapy | To assess the effects of study treatment on number of patients who needed renal replacement therapy | Within 28 days and up to 6 months after randomisation | |
| Other | Number of patients who had thrombotic events | To assess the effects of study treatment on number of patients who had thrombotic events | Within 28 days and up to 6 months after randomisation | |
| Other | Cardiac outcome (long-term impact) of PIMS-TS after discharge | Cardiac function and presence of coronary artery aneurysms will be assessed by echocardiography. | Post-discharge extended follow-up visits up to 6 months after randomisation | |
| Other | Neurological outcome (long-term impact) of PIMS-TS after discharge | assessment of post-traumatic stress disorder | Post-discharge extended follow-up visits up to 6 months after randomisation | |
| Other | Health care costs | 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 | Within 28 days after randomisation | |
| Other | Quality of life post-infection assessed by Strengths and Difficulties Questionnaire (SDQ) | 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. |
Post-discharge extended follow-up visits up to 6 months after randomisation | |
| Primary | Hospital length of stay | effect of study treatment on hospital length of stay | Within 28 days after randomisation | |
| Secondary | All-cause mortality among patients | 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. | Within 28 days and up to 6 months after randomisation | |
| Secondary | Composite endpoint of death or need for mechanical ventilation or extracorporeal membrane oxygenation (ECMO) | 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. | Within 28 days and up to 6 months after randomisation |