Trial · NCT04826588
Randomised Evaluation of COVID-19 Therapy (RECOVERY) in Children With PIMS-TS in Switzerland (SWISSPED-RECOVERY)
NCT04826588, Phase 3, Completed, University Children's Hospital Basel
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Randomised Evaluation of COVID-19 Therapy (RECOVERY) in Children With PIMS-TS in Switzerland (SWISSPED-RECOVERY). Trials, record NCT04826588. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04826588
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Randomised Evaluation of COVID-19 Therapy (RECOVERY) in Children With PIMS-TS in Switzerland (SWISSPED-RECOVERY)
- NCT number
- NCT04826588
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 76 participants, actual
- Lead sponsor
- University Children's Hospital Basel
- Conditions
- Paediatric Inflammatory Multisystem Syndrome-Temporally Associated With SARS-CoV-2 (PIMS-TS)
- Interventions
- Methylprednisolone sodium succinate 10 mg/kg intravenously, Human normal immunoglobulin (IVIg)
- First posted
- 2021-04-01
- Last updated
- 2025-02-13
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Hospital length of stay | Within 28 days after randomisation | effect of study treatment on hospital length of stay |
| Secondary | All-cause mortality among patients | 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. |
| Secondary | Composite endpoint of death or need for mechanical ventilation or extracorporeal membrane oxygenation (ECMO) | 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 | Need for (and duration of) ventilation | 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 |
| Other | Need for renal replacement therapy | 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 |
| Other | Number of patients who had thrombotic events | 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 |
| Other | Cardiac outcome (long-term impact) of PIMS-TS after discharge | 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. |
| Other | Neurological outcome (long-term impact) of PIMS-TS after discharge | Post-discharge extended follow-up visits up to 6 months after randomisation | assessment of post-traumatic stress disorder |
| Other | Health care costs | 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 |
| Other | Quality of life post-infection assessed by Strengths and Difficulties Questionnaire (SDQ) | 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. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers5
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04826588
GET https://conductscience.org/api/trials/v1/NCT04826588/registered