A Phase 2 interventional study of Tocilizumab and Baricitinib in Sepsis, sponsored by Assistance Publique - Hôpitaux de Paris. Recruiting at 19 sites in France. Open to participants aged 37 Weeks and older. Per ClinicalTrials.gov, last updated 2026-10-20.
Sponsored by Assistance Publique - Hôpitaux de Paris · Phase 2, Interventional, and Treatment
PALETTE is a perpetual adaptive platform to efficiently study sepsis interventions within 'treatable traits' in all-ages patients enabling prompt evaluation of pandemic treatments. Treatable traits, therapeutic targets identified by phenotypes or endotypes (defined by biological mechanism or by treatment response) through validated biomarkers (measurable characteristic reflecting normal or pathogenic processes, or treatment responses), may include multi-omics, cellular, immune, metabolic, endocrine features, or intelligent algorithms. PALETTE Bayesian adaptive design enables parallel investigations of multiple interventions for sepsis, and quick inclusion of pandemic pathogens. PALETTE's new conceptual model will respond to the challenges of standard approaches, i.e. series of sepsis trials, each investigating one or two interventions, expensive, time consuming, and inappropriate in pandemic context.
2,416 studies on the registry are indexed under Sepsis; 541 are open to participants now.
This study's planned enrollment of 2,000 is above the median of 102 across 1,165 interventional studies indexed under Sepsis.
Browse Sepsis studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,592 studies on the registry; 1,033 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Platform inclusion criteria will be:
Briefly, all following criteria will be required:
Sequential Organ Failure Assessment (SOFA) score ≥2 for adults, and PHOENIX sepsis score of ≥2 for children.
Platform exclusion criteria:
Any of the following:
Treatable trait inclusion criteria :
There are also inclusion and exclusion criteria related to treatable traits and interventions.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Tocilizumab
Drug: Baricitinib
Drug: Anakinra
Other: blood purification with MTx.100 Plasma Adsorption Column
Other: Usual care
Drug: Heparin · Drug: G-CSF filgrastim
Drug: Interferon gamma-1b
Other: Usual care
Drug: Anakinra
Other: blood purification with MTx.100 Plasma Adsorption Column
Other: Usual care
Drug: Hydrocortisone
Drug: Fludrocortisone
Drug: Hydrocortisone and fludrocortisone
Other: Usual care
Drug: Prophylactic unfractionated heparin (UFH)
Drug: Heparin
Drug: Low molecular weight heparin
Drug: Recombinant humanThrombomodulin( rhTM)
Other: Usual care
Drug: Sivelestat
Drug: Octaplas LG
Drug: Plasminogen
Other: Usual care
8 mg per kilogram of body weight enterally (oral or via a gastric tube) once daily for 14 days (or hospital discharge pending which will occur first) (same for adults and children)
4mg, enterally (oral or via a gastric tube) once daily for 14 days (or hospital discharge pending which will occur first) (same for adults and children)
100 mg subcutaneously once daily for 10 days (or hospital discharge pending which will occur first) (same for adults and children)
50mg (in children: 1-2 mg/kg) IV Q6 for 7 days
Drug pages: Hydrocortisone · Fludrocortisone
Hydrocortisone 50mg IV Q6 for 7 days + Fludrocortisone 50mg orally or via gastric tube once a day for 7 days.
Therapeutic unfractionated heparin (UFH) starting at 400 (in children: 20 IU/kg/h) IU/kg/24h (target between 0.3 and 0.5 IU/ml), adapted to the therapeutic Partial Thromboplastin Time targeting values in the range of 60 to 100 seconds, with lower intensity dosing in the range of 60 to 80 seconds, for 7 days (or ICU discharge, pending which will occur first).
Therapeutic low weight molecular heparin (LMWH) tinzaparin, considering its contraindications, recommended dose ranges and monitoring if applicable, as follows: 175 (in children 100 U/kg) IU/kg/24h, for 7 days (or hospital discharge pending which will occur first).
Recombinant human thrombomodulin (rhTM) 0.06 mg/kg/j IV, for 7 days (or ICU discharge, pending which will occur first).
0.2 mg/kg/h for 7 days (or ICU discharge, pending which will occur first)
Usual care
up to 4 hours a day, up to four days in a row
Drug pages: Granulocyte Colony-Stimulating Factor · Filgrastim
0.5 MIU (5μg)/kg/day subcutaneously for 5 consecutive days (or up to ICU discharge pending which occurs first) - same for adults and children .
rhIFNg subcutaneously at 50 µg/m2 if body surface \>0,5 m2, or 1.5µg/kg if body surface of 0,5 m2or less, every other day for 15 days (or up to ICU discharge pending which occurs first)
50µg orally (or via the gastric tube) once a day for 7 days (or ICU discharge pending which will occur first) (same for adults and children)
100 IU/kg/24h for 6 days
12 mL/kg on day 1; repeated daily from day 2 to day 5, provided that PT/INR remains ≥ 1.40 (This intervention will be opened for randomisation once a supply circuit is in place)
2,2 mg/kg/day (intravenous infusion) during 3 days.
All-cause mortality
Dual primary endpoint
Time frame: At day 28
Number of days alive without persistent life-supportive therapies
Dual primary endpoint Respiratory support: high flow oxygen, non-invasive or invasive mechanical ventilation, extracorporeal membrane oxygenation or CO2 removal; cardiovascular support: continuous infusion of any dose of vasopressor or inotrope, or mechanical circulatory assistance; renal support: intermittent or continuous renal replacement therapy
Time frame: At day 28
Net benefit probability of intervention vs. control, assessed with a Generalized Pairwise Comparison (mortality prioritized over life-support-free days)
The Generalized Pairwise Comparison (GPC) method will be used to derive a single composite outcome. Each patient in the intervention group will be compared to each patient in the control group. For each pair, a score of +1, -1, or 0 will be assigned according to prioritized outcomes: (1) all-cause mortality at day 28, and (2) number of days alive without life-supportive therapies at day 28 if both patients have the same mortality status. The net benefit will be calculated as the sum of all pairwise scores divided by the total number of pairs, corresponding to the probability that a randomly chosen patient has a better outcome in one group than in the other.
Time frame: At day 28
Overall Survival
Time frame: At day 90
Overall Survival
Time frame: At 1 year
Overall Survival
Time frame: At 3 years
Number of hospital free days
Time frame: At 1 year
Number of hospital free days
Time frame: At 3 years
Time to recover walking
Time frame: At day 90
Time to resume previous social and professional activities
Time frame: At 1 year
Quality of life score for adults assessed by SF-36
The Short Form (36) (SF-36) Health Survey is a 36-item measure if health status. The score obtained varies between 0 and 100. The higher the score the less disability. Ware JE, Sherbourne CD. The MOS 36-item short-form health survey (SF-36): I. Conceptual framework and item selection. Med Care 1992;30:473-83.
Time frame: At day 90
Quality of life score for adults assessed by EQ-5D-5L
EQ-5D-5L : It evaluates five dimensions : mobility, self-care, usual activities, pain/discomfort and anxiety/depression and each dimension has five levels : no problems, slight problems, moderate problems, severe problems and extreme problems. Answers are given on a 5-point scale by domain, the higher the score, the poorer the quality of life.
Time frame: At day 90
Pediatric Quality of Life Inventory (PedsQL)
Standardized tool used to measure health-related quality of life (HRQoL) in children and adolescents (ages 2-18) It is a 23-item score divided in four domains : Phtsical functioning, Emotional functioning, Social functioning, School functioning The total score vary from 0 to 100. The higher the score the hiher the quality of life.
Time frame: At day 90
Quality of life score for children assessed by FSS
Functional Status Scale (FFS) : It examines 6 domains of functioning, and each domain receives a score of 1 (normal), 2 (mild dysfunction), 3 (moderate dysfunction), 4 (severe dysfunction), or 5 (very severe dysfunction). Final scores range from 6 to 30.
Time frame: At day 90
Quality of life score for adults assessed by SF-36
The Short Form (36) (SF-36) Health Survey is a 36-item measure if health status. The score obtained varies between 0 and 100. The higher the score the less disability. Ware JE, Sherbourne CD. The MOS 36-item short-form health survey (SF-36): I. Conceptual framework and item selection. Med Care 1992;30:473-83.
Time frame: At 1 year
Quality of life score for adults assessed by EQ-5D-5L
EQ-5D-5L : It evaluates five dimensions : mobility, self-care, usual activities, pain/discomfort and anxiety/depression and each dimension has five levels : no problems, slight problems, moderate problems, severe problems and extreme problems. Answers are given on a 5-point scale by domain, the higher the score, the poorer the quality of life.
Time frame: At 1 year
Quality of life score for children assessed by FSS
Functional Status Scale (FFS) : It examines 6 domains of functioning, and each domain receives a score of 1 (normal), 2 (mild dysfunction), 3 (moderate dysfunction), 4 (severe dysfunction), or 5 (very severe dysfunction). Final scores range from 6 to 30.
Time frame: At 1 year
Pediatric Quality of Life Inventory (PedsQL)
Standardized tool used to measure health-related quality of life (HRQoL) in children and adolescents (ages 2-18) It is a 23-item score divided in four domains : Phtsical functioning, Emotional functioning, Social functioning, School functioning The total score vary from 0 to 100. The higher the score the hiher the quality of life.
Time frame: At 1 year
Quality of life score for adults assessed by SF-36
The Short Form (36) (SF-36) Health Survey is a 36-item measure if health status. The score obtained varies between 0 and 100. The higher the score the less disability. Ware JE, Sherbourne CD. The MOS 36-item short-form health survey (SF-36): I. Conceptual framework and item selection. Med Care 1992;30:473-83.
Time frame: At 3 years
Quality of life score for adults assessed by EQ-5D-5L
EQ-5D-5L : It evaluates five dimensions : mobility, self-care, usual activities, pain/discomfort and anxiety/depression and each dimension has five levels : no problems, slight problems, moderate problems, severe problems and extreme problems. Answers are given on a 5-point scale by domain, the higher the score, the poorer the quality of life.
Time frame: At 3 years
Quality of life score for children assessed by FSS
Functional Status Scale (FFS) : It examines 6 domains of functioning, and each domain receives a score of 1 (normal), 2 (mild dysfunction), 3 (moderate dysfunction), 4 (severe dysfunction), or 5 (very severe dysfunction). Final scores range from 6 to 30.
Time frame: At 3 years
Pediatric Quality of Life Inventory (PedsQL)
Standardized tool used to measure health-related quality of life (HRQoL) in children and adolescents (ages 2-18) It is a 23-item score divided in four domains : Phtsical functioning, Emotional functioning, Social functioning, School functioning The total score vary from 0 to 100. The higher the score the hiher the quality of life.
Time frame: At 3 years
Number of adverse events
Tolerance of interventions considering any grade of 3 serious adverse events.
Time frame: Up to 3 years
Incidence of new sepsis episodes
Time frame: At day 90
Incidence of new sepsis episodes
Time frame: At 1 year
Incidence of new sepsis episodes
Time frame: At 3 years
Incidence of new unscheduled hospitalizations
Time frame: At day 90
Incidence of new unscheduled hospitalizations
Time frame: At 1 year
Incidence of new unscheduled hospitalizations
Time frame: At 3 years
Incidence of sequels in neurocognitive, neuromuscular; cardiovascular, respiratory, renal, metabolic, and immune systems
Time frame: At 3 years
Number of grade 3 serious adverse events
Time frame: At day 28
Circulating levels of cytokines
Time frame: At inclusion
Circulating levels of chemokines
Time frame: At inclusion
Circulating levels of cytokines
Time frame: At day 1
Circulating levels of chemokines
Time frame: At day 1
Circulating levels of cytokines
Time frame: At day 7
Circulating levels of chemokines
Time frame: At day 7
Circulating levels of cytokines
Time frame: At 1 year
Circulating levels of chemokines
Time frame: At 1 year
Circulating levels of cytokines
Time frame: At 3 years
Circulating levels of chemokines
Time frame: At 3 years
Plan to share: Undecided
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drugs tested here: Tocilizumab · Baricitinib · Interleukin 1 Receptor Antagonist Protein · Hydrocortisone · Fludrocortisone · Heparin · Heparin, Low-Molecular-Weight · Sivelestat · Granulocyte Colony-Stimulating Factor · Filgrastim · Interferon gamma-1b · Plasminogen
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