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Life sciences · Phase 2 Trial
ClinicalTrials.gov · October 20, 2026
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Phase 2 Trial.
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Registry record from ClinicalTrials.gov (NCT06381661). This is a study registration, not published results. Lead sponsor: Assistance Publique - Hôpitaux de Paris. Recruitment status: RECRUITING. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 2000 participants (ESTIMATED). Conditions: Sepsis. Interventions: DRUG: Tocilizumab; DRUG: Baricitinib; DRUG: Anakinra; DRUG: Hydrocortisone; DRUG: Hydrocortisone and fludrocortisone; DRUG: Heparin; DRUG: Low molecular weight heparin; DRUG: Recombinant humanThrombomodulin( rhTM); DRUG: Sivelestat; OTHER: Usual care; OTHER: blood purification with MTx.100 Plasma Adsorption Column; DRUG: G-CSF filgrastim; DRUG: Interferon gamma-1b; DRUG: Fludrocortisone; DRUG: Prophylactic unfractionated heparin (UFH); DRUG: Octaplas LG; DRUG: Plasminogen. Primary outcome measures: All-cause mortality , At day 28; Number of days alive without persistent life-supportive therapies , At day 28. Brief summary: 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.