PMC:7534795 / 39597-46304 JSONTXT

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Results pending (NCT04322188, 2020)\n• COV-AID Trial\n• Use of anti-interleukin agents for cytokine storm • Phase 3 prospective RCT\n• Patients with signs of cytokine storm\n• N = 38 Anakinra alone (anti-IL-1 receptor)\n• N = 76 Siltuximab alone (anti-IL-6)\n• N = 38 Anakinra + siltuximab\n• N = 76 Tocilizumab alone (anti-IL-6 receptor)\n• N = 38 Anakinra + tocilizumab\n• N = 76 standard care alone\n• Primary outcome as time to clinical improvement • Anakinra 100 mg s.c. daily for 28 days\n• Siltuximab single i.v. infusion 11 mg/kg\n• Tocilizumab single i.v. infusion 8 mg/kg max 800 mg (Maes et al., 2020)\n• Sarilumab for hospitalized COVID-19 infections\n• Cytokine storm syndrome • Phase 2/3 RCT\n• Phase 2: Sarilumab in hospitalized patients regardless of disease severity vs. placebo\n• Primary outcome of % change in CRP in patients with serum IL-6 \u003e upper limit normal\n• Phase 3 Cohort 1: Sarilumab in hospitalized critical infection receiving mechanical ventilation vs. placebo\n• Cohort 2: Sarilumab in hospitalized infection receiving mechanical ventilation vs. placebo\n• N = 1912\n• Primary outcome of at least 1 point improvement on 7 point clinical scale • Phase 2: Low dose sarilumab i.v.\n• Phase 2: Mid-dose sarilumab i.v.\n• Phase 3 Cohort 1: Low dose sarilumab i.v.\n• Phase 3 Cohort 1: Mid-dose sarilumab i.v.\n• Phase 3 Cohort 2: High dose sarilumab i.v.\n• Placebo given to match sarilumab administration (NCT04315298, 2020)\n• CORIMUNO-SARI Trial\n• Sarilumab to mitigate enhanced IL-6 signalling • RCT\n• Moderate, severe, or critical COVID-19 pneumonia\n• Sarilumab vs. standard of care\n• N = 239 • Sarilumab 400 mg single i.v. infusion over 1 h on day 1 (NCT04324073, 2020)\n• Barcitinib for hospitalized COVID-19 patients • Non-randomized clinical trial\n• Any adult patient hospitalized with moderate/severe COVID-19\n• Barcitinib + standard care vs. standard care alone\n• Primary outcome of clinical status after 15 days • Barcitinib 2 mg orally daily for 10 days (NCT04321993, 2020)\n• RUXCOVID Trial • Phase 3 placebo-controlled RCT\n• Patients age ≥ 12 with cytokine storm\n• Ruxolitinib + standard care vs. placebo + standard care\n• N = 402 randomized in 2:1 ratio\n• treatment: placebo • Ruxolitinib 5 mg orally twice daily for 14 days\n• May extend treatment to 28 days (NCT04362137, 2020)\n• Losartan (ARB) in patients hospitalized for COVID-19 • Phase 2 RCT\n• Losartan vs. placebo + standard care\n• N = 200\n• Secondary outcome includes cardiovascular organ failure/dysfunction • Losartan 50 mg orally once daily (NCT04312009, 2020)\n• Losartan (ARB) in patients not requiring hospitalization for COVID-19 • Phase 2 RCT\n• Losartan vs. placebo + standard care\n• N = 500\n• Primary outcome of patients admitted to hospital within 15 days of randomization • Losartan 25 mg orally once daily (NCT04311177, 2020)\n• Eicosapentaenoic acid (EPA) free fatty acid for hospitalized COVID-19 patients • Phase 3 interventional trial\n• Treatment with EPA gastro-resistant capsules vs. standard care\n• 28-day treatment period\n• Primary outcome of time to treatment failure i.e. need for additional therapy, intubation, transfer to ICU, or death\n• Secondary outcome includes reduction of IL-6 levels • Eicosapentaenoic acid free fatty acid (EPA-FFA) 1 g gastro-resistant capsules twice daily (2 g total) (NCT04335032, 2020)\n• COLCORONA Trial\n• Colchicine and inflammatory cytokine storm • Phase 3 multi-centre placebo-controlled randomized controlled trial (RCT)\n• Age 40 years or older\n• Patients must have at least one high-risk factor i.e. uncontrolled hypertension, HF, coronary artery disease (CAD), diabetes, obesity, etc.\n• Colchicine vs. placebo\n• 30-day treatment\n• N = 6000\n• Primary composite endpoint of need for hospitalization or death • Colchicine 0.5 mg orally twice daily for 3 days, then 0.5 mg once daily for 27 days\n• Placebo will match colchicine administration (NCT04322682, 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