Paediatric Inflammatory Multisystem Syndrome-Temporally Associated With SARS-CoV-2 (PIMS-TS)Phase 3NCT04826588
Randomised Evaluation of COVID-19 Therapy (RECOVERY) in Children With PIMS-TS in Switzerland (SWISSPED-RECOVERY)
A Phase 3 study testing Methylprednisolone sodium succinate 10 mg/kg intravenously and Human normal immunoglobulin (IVIg) in people with Paediatric Inflammatory Multisystem Syndrome-Temporally Associated With SARS-CoV-2 (PIMS-TS), run by University Children's Hospital Basel at 10 sites in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 44 weeks to 18 years
- Conditions the study is for
- Paediatric Inflammatory Multisystem Syndrome-Temporally Associated With SARS-CoV-2 (PIMS-TS)
- What is being tested?
- Methylprednisolone sodium succinate 10 mg/kg intravenously and Human normal immunoglobulin (IVIg)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 10 sitesSwitzerland
- Study dates
- 23 May 2021to 20 Nov 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 44 weeks to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Switzerland10 sites
Cantonal Hospital Aarau, Department of Paediatrics
Aarau, 5001
University of Basel Children's Hospital
Basel, 4056
Ente Ospedaliero Cantonale Ticino (EOC) Pediatrica
Bellinzona, 6500
Department of Pediatrics, University of Bern
Bern, 3010
Department of Child, Woman and, Adolescent Medecine, Geneva University Hospitals and Faculty of Medicine
Geneva
Department of Pediatrics,University Hospital of Lausanne (CHUV)
Lausanne
Department of Pediatrics, Cantonal Hospital Luzern
Lucerne, 6000
Children's Hospital of Eastern Switzerland
Sankt Gallen, 9006
Department of Pediatrics, Cantonal Hospital Fribourg
Villars-sur-Glâne, 1752
University Children's Hospital Zuerich
Zurich, 8032
About this study
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.
Read the 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. 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.
- Conditions
- Paediatric Inflammatory Multisystem Syndrome-Temporally Associated With SARS-CoV-2 (PIMS-TS)
- Being tested
- Methylprednisolone sodium succinate 10 mg/kg intravenously, Human normal immunoglobulin (IVIg)
- Keywords
- coronavirus-disease (COVID-19), SARS coronavirus 2 (SARS-CoV-2), tocilizumab, anakinra, Human normal immunoglobulin (IVIg), Methylprednisolone sodium succinate
- Medical subject headings
- pediatric multisystem inflammatory disease, COVID-19 related, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methylprednisolone sodium succinate 10 mg/kg intravenouslyDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Methylprednisolone sodium succinate 10 mg/kg | Active comparator | Methylprednisolone sodium succinate 10 mg/kg intravenously once daily for 3 days (max 1 g per dose) Receives: Drug: Methylprednisolone sodium succinate 10 mg/kg intravenously |
| Human normal immunoglobulin (IVIg) | Active comparator | Human normal immunoglobulin (IVIg) 2g/kg intravenously as a single dose in line with guidance for dosing and administration in Kawasaki disease Receives: Biological: Human normal immunoglobulin (IVIg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital length of stay
effect of study treatment on hospital length of stay
Measured: Within 28 days after randomisation
Secondary outcomes (2)
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.
Measured: Within 28 days and up to 6 months after randomisation
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.
Measured: Within 28 days and up to 6 months after randomisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start23 May 2021
- Primary completion20 Nov 2022
- Study completion20 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Paediatric Inflammatory Multisystem Syndrome-Temporally Associated With SARS-CoV-2 (PIMS-TS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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: Methylprednisolone 2 mg/kg for three days intravenous or orally vs corticosteroids methylprednisolone 10mg/kg intravenous for three days vs intravenous immunoglobulin.
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Children's Hospital Basel
- Sponsor type
- University, hospital or other
- Collaborators
- SwissPedNet
- Responsible party
- Sponsor
- Investigators
- Julia Bielicki, Dr. med., Principal investigator, Paediatric Infectious Diseases and Vaccinology, Universität-Kinderspital beider Basel (UKBB)Luregn Schlapbach, Dr. med., Principal investigator, Pediatric and Neonatal Intensive Care Unit, University Children's Hospital Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04826588
- Sponsor's protocol ID
- 2021-00362; ks21Bielicki2
- Status last verified
- Feb 2023
- First submitted
- 31 Mar 2021
- Last updated
- 13 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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 intravenous immunoglobulins in children with paediatric inflammatory multisystem syndrome temporally associated with SARS-CoV-2 (PIMS-TS): an open-label, multicentre, randomised trial. Lancet Child Adolesc Health. 2023 Apr;7(4):238-248. doi: 10.1016/S2352-4642(23)00020-2. Epub 2023 Feb 3.
PubMed 36746174Schobi N, Sanchez C, Welzel T, Bamford A, Webb K, Rojo P, Tremoulet A, Atkinson A, Schlapbach LJ, Bielicki JA; Swissped-RECOVERY trial group. Swissped-RECOVERY: masked independent adjudication for the interpretation of non-randomised treatment in a two-arm open-label randomised controlled trial (methylprednisolone vs immunoglobulins) in Paediatric Inflammatory Multisystem Syndrome Temporally Associated with SARS-CoV-2 (PIMS-TS) involving 10 secondary and tertiary paediatric hospitals in Switzerland. BMJ Open. 2024 Apr 25;14(4):e078137. doi: 10.1136/bmjopen-2023-078137.
PubMed 38670610Andre MC, Sanchez C, Bressieux-Degueldre S, Perez MH, Wutz D, Blanchard-Rohner G, Grazioli S, Schobi N, Truck J, Welzel T, Atkinson A, Schlapbach LJ, Bielicki J; Swissped RECOVERY Trial Group. Cardiac assessment and inflammatory markers in children with paediatric inflammatory multisystem syndrome temporally associated with SARS-CoV2 (PIMS-TS) treated with methylprednisolone versus intravenous immunoglobulins: 6-month follow-up outcomes of the randomised controlled Swissped RECOVERY trial. EClinicalMedicine. 2023 Dec 6;67:102358. doi: 10.1016/j.eclinm.2023.102358. eCollection 2024 Jan.
PubMed 38107550Welzel T, Schobi N, Andre MC, Bailey DGN, Blanchard-Rohner G, Buettcher M, Grazioli S, Koehler H, Perez MH, Truck J, Vanoni F, Zimmermann P, Atkinson A, Sanchez C, Whittaker E, Faust SN, Bielicki JA, Schlapbach LJ; Swissped Recovery Trial. 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. Front Pediatr. 2022 May 20;10:905046. doi: 10.3389/fped.2022.905046. eCollection 2022.
PubMed 35669398Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.
PubMed 34473343
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Evaluation of COVID-19 Therapy (RECOVERY) in Children With PIMS-TS in Switzerland (SWISSPED-RECOVERY)
- ClinicalTrials.gov ID
- NCT04826588
- Acronym / sponsor ID
- 2021-00362; ks21Bielicki2
- Conditions
- Paediatric Inflammatory Multisystem Syndrome-Temporally Associated With SARS-CoV-2 (PIMS-TS)
- Keywords
- coronavirus-disease (COVID-19), SARS coronavirus 2 (SARS-CoV-2), tocilizumab, anakinra, Human normal immunoglobulin (IVIg), Methylprednisolone sodium succinate
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- University Children's Hospital BaselUniversity, hospital or other
- Collaborators
- SwissPedNet
- Study start
- 23 May 2021 (actual)
- Primary completion
- 20 Nov 2022 (actual)
- Study completion
- 20 Nov 2022 (actual)
- First posted
- 1 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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. 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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: Methylprednisolone 2 mg/kg for three days intravenous or orally vs corticosteroids methylprednisolone 10mg/kg intravenous for three days vs intravenous immunoglobulin.
| Arm | Type | Receives |
|---|---|---|
| Methylprednisolone sodium succinate 10 mg/kg | Active comparator | Drug: Methylprednisolone sodium succinate 10 mg/kg intravenouslyMethylprednisolone sodium succinate 10 mg/kg intravenously once daily for 3 days (max 1 g per dose) |
| Human normal immunoglobulin (IVIg) | Active comparator | 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 |
Who may qualify
- Ages
- 44 weeks to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Methylprednisolone sodium succinate 10 mg/kg intravenouslyMethylprednisolone sodium succinate 10 mg/kg intravenously once daily for 3 days (max 1 g per dose) | Drug | Methylprednisolone sodium succinate 10 mg/kg |
| 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) |
Primary outcome
Hospital length of stay
Time frame: Within 28 days after randomisation
effect of study treatment on hospital length of stay
2 secondary outcomes
All-cause mortality among patients
Time frame: Within 28 days and up to 6 months after randomisation
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2025.
- Results publication: PubMed 36746174Welzel 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 intravenous immunoglobulins in children with paediatric inflammatory multisystem syndrome temporally associated with SARS-CoV-2 (PIMS-TS): an open-label, multicentre, randomised trial. Lancet Child Adolesc Health. 2023 Apr;7(4):238-248. doi: 10.1016/S2352-4642(23)00020-2. Epub 2023 Feb 3.
- Derived from this study: PubMed 38670610Schobi N, Sanchez C, Welzel T, Bamford A, Webb K, Rojo P, Tremoulet A, Atkinson A, Schlapbach LJ, Bielicki JA; Swissped-RECOVERY trial group. Swissped-RECOVERY: masked independent adjudication for the interpretation of non-randomised treatment in a two-arm open-label randomised controlled trial (methylprednisolone vs immunoglobulins) in Paediatric Inflammatory Multisystem Syndrome Temporally Associated with SARS-CoV-2 (PIMS-TS) involving 10 secondary and tertiary paediatric hospitals in Switzerland. BMJ Open. 2024 Apr 25;14(4):e078137. doi: 10.1136/bmjopen-2023-078137.
- Derived from this study: PubMed 38107550Andre MC, Sanchez C, Bressieux-Degueldre S, Perez MH, Wutz D, Blanchard-Rohner G, Grazioli S, Schobi N, Truck J, Welzel T, Atkinson A, Schlapbach LJ, Bielicki J; Swissped RECOVERY Trial Group. Cardiac assessment and inflammatory markers in children with paediatric inflammatory multisystem syndrome temporally associated with SARS-CoV2 (PIMS-TS) treated with methylprednisolone versus intravenous immunoglobulins: 6-month follow-up outcomes of the randomised controlled Swissped RECOVERY trial. EClinicalMedicine. 2023 Dec 6;67:102358. doi: 10.1016/j.eclinm.2023.102358. eCollection 2024 Jan.
- Derived from this study: PubMed 35669398Welzel T, Schobi N, Andre MC, Bailey DGN, Blanchard-Rohner G, Buettcher M, Grazioli S, Koehler H, Perez MH, Truck J, Vanoni F, Zimmermann P, Atkinson A, Sanchez C, Whittaker E, Faust SN, Bielicki JA, Schlapbach LJ; Swissped Recovery Trial. 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. Front Pediatr. 2022 May 20;10:905046. doi: 10.3389/fped.2022.905046. eCollection 2022.
- Derived from this study: PubMed 34473343Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julia Bielicki, Dr. med. principal investigator
Paediatric Infectious Diseases and Vaccinology, Universität-Kinderspital beider Basel (UKBB)
Luregn Schlapbach, Dr. med. principal investigator
Pediatric and Neonatal Intensive Care Unit, University Children's Hospital Zurich
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Methylprednisolone sodium succinate 10 mg/kg intravenously and Human normal immunoglobulin (IVIg) in people with Paediatric Inflammatory Multisystem Syndrome-Temporally Associated With SARS-CoV-2 (PIMS-TS), run by University Children's Hospital Basel at 10 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital length of stay (time frame: Within 28 days after randomisation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04826588, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2025.