PMC:7534795 / 39597-46304 JSON TXT

Annnotations TAB JSON ListView MergeView

LitCovid-PD-FMA-UBERON

LitCovid-PD-UBERON

LitCovid-PD-MONDO

LitCovid-PD-CLO

LitCovid-PD-CHEBI

LitCovid-PD-GO-BP

{"project":"LitCovid-PD-GO-BP","denotations":[{"id":"T93","span":{"begin":4302,"end":4312},"obj":"http://purl.obolibrary.org/obo/GO_0023052"}],"text":"Pharmacological intervention Sample size and criteria Treatment protocol Reference\n• TACTIC-E Trial\n• Immunomodulatory agents • Multi-arm randomized trial\n• Pre-intensive care unit (ICU) COVID-19 patients\n• Immunomodulatory drug EDP1815 vs. dapagliflozin + ambrisentan vs. standard care\n• Primary outcome includes need for cardiovascular organ support • EDP1815 as 2 capsules twice daily (1.6 × 1011 cells) for up to 7 days\n• Dapagliflozin 10 mg + ambrisentan 5 mg once daily (NCT04393246, 2020)\n• High dose IV Vitamin C to ameliorate cytokine storm and associated organ dysfunction • Prospective placebo controlled randomized controlled trial (RCT)\n• N = 308\n• High dose i.v. vitamin C (HIVC) vs. placebo\n• Primary outcome of ventilator-free days • 12 g/50 ml vitamin C infusion 12 ml/h twice daily for 7 days vs. 50 ml sterile water for injection infused at 12 ml/h (Liu, Zhu, Zhang, Li, \u0026 Peng, 2020)\n• TOC-COVID Trial • Prospective placebo controlled RCT\n• N = 100 tocilizumab + standard treatment\n• N = 100 placebo + standard treatment\n• Primary outcome of ventilation-free days • Tocilizumab 8 mg/kg single i.v. dose (Rilinger et al., 2020)\n• TACTIC-R Trial\n• Immunomodulatory agents • Randomized parallel 3-arm open label trial\n• N = 125 Baricitinib\n• N = 125 Ravulizumab\n• N = 125 standard of care\n• Primary outcome includes need for cardiovascular organ support • Baricitinib 4 mg orally once daily on days 1–14\n• Ravulizumab single i.v. weight-based dose regimen (Kulkarni et al., 2020)\n• CytoResc Trial\n• Cytokine storm in hyperinflammation and shock • Prospective, open-label, pilot study\n• ‘CytoSorb’ polystyrene-based hemoadsorber to adsorb circulating cytokines\n• N = 40–50 ‘CytoSorb’\n• N = 40–50 standard care\n• Primary outcome is time to resolution of vasoplegic shock • ‘CytoSorb’ therapy administered via a shaldon catheter for 3–7 days (Stockmann et al., 2020)\n• MelCOVID Trial • Double blind placebo controlled RCT\n• ICU COVID-19 patients\n• N = 12 melatonin + standard of care\n• N = 6 placebo control + standard care\n• Secondary outcome includes CRP, IL-6 levels • Melatonin 5 mg/kg/day i.v. divided every 6 h for 7 days\n• Placebo dose of 5 mg/kg/day i.v. divided every 6 h for 7 days (Rodriguez-Rubio et al., 2020)\n• Siltuximab for patients diagnosed with severe respiratory complications due to COVID-19\n• Anti-IL-6 mitigation of cytokine storm • Observational retrospective cohort study\n• Cohort A: continuous positive airway pressure followed by siltuximab\n• Cohort B: intubation followed by siltuximab\n• Control group receiving continuous positive airway pressure or intubation only\n• N = 220\n• Primary outcome of mortality over 30 days • Detailed siltuximab dosing regimen not specified.\n• Treatment procedure was based on clinicians judgement\n• Study completed May 8, 2020. 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, 2020)"}

LitCovid-sentences

LitCovid-PD-HP

2_test

{"project":"2_test","denotations":[{"id":"33031856-32493514-84038882","span":{"begin":1143,"end":1147},"obj":"32493514"},{"id":"33031856-32641154-84038883","span":{"begin":1495,"end":1499},"obj":"32641154"},{"id":"33031856-32586396-84038884","span":{"begin":1880,"end":1884},"obj":"32586396"},{"id":"33031856-32758298-84038885","span":{"begin":2237,"end":2241},"obj":"32758298"},{"id":"33031856-32493441-84038886","span":{"begin":3406,"end":3410},"obj":"32493441"}],"text":"Pharmacological intervention Sample size and criteria Treatment protocol Reference\n• TACTIC-E Trial\n• Immunomodulatory agents • Multi-arm randomized trial\n• Pre-intensive care unit (ICU) COVID-19 patients\n• Immunomodulatory drug EDP1815 vs. dapagliflozin + ambrisentan vs. standard care\n• Primary outcome includes need for cardiovascular organ support • EDP1815 as 2 capsules twice daily (1.6 × 1011 cells) for up to 7 days\n• Dapagliflozin 10 mg + ambrisentan 5 mg once daily (NCT04393246, 2020)\n• High dose IV Vitamin C to ameliorate cytokine storm and associated organ dysfunction • Prospective placebo controlled randomized controlled trial (RCT)\n• N = 308\n• High dose i.v. vitamin C (HIVC) vs. placebo\n• Primary outcome of ventilator-free days • 12 g/50 ml vitamin C infusion 12 ml/h twice daily for 7 days vs. 50 ml sterile water for injection infused at 12 ml/h (Liu, Zhu, Zhang, Li, \u0026 Peng, 2020)\n• TOC-COVID Trial • Prospective placebo controlled RCT\n• N = 100 tocilizumab + standard treatment\n• N = 100 placebo + standard treatment\n• Primary outcome of ventilation-free days • Tocilizumab 8 mg/kg single i.v. dose (Rilinger et al., 2020)\n• TACTIC-R Trial\n• Immunomodulatory agents • Randomized parallel 3-arm open label trial\n• N = 125 Baricitinib\n• N = 125 Ravulizumab\n• N = 125 standard of care\n• Primary outcome includes need for cardiovascular organ support • Baricitinib 4 mg orally once daily on days 1–14\n• Ravulizumab single i.v. weight-based dose regimen (Kulkarni et al., 2020)\n• CytoResc Trial\n• Cytokine storm in hyperinflammation and shock • Prospective, open-label, pilot study\n• ‘CytoSorb’ polystyrene-based hemoadsorber to adsorb circulating cytokines\n• N = 40–50 ‘CytoSorb’\n• N = 40–50 standard care\n• Primary outcome is time to resolution of vasoplegic shock • ‘CytoSorb’ therapy administered via a shaldon catheter for 3–7 days (Stockmann et al., 2020)\n• MelCOVID Trial • Double blind placebo controlled RCT\n• ICU COVID-19 patients\n• N = 12 melatonin + standard of care\n• N = 6 placebo control + standard care\n• Secondary outcome includes CRP, IL-6 levels • Melatonin 5 mg/kg/day i.v. divided every 6 h for 7 days\n• Placebo dose of 5 mg/kg/day i.v. divided every 6 h for 7 days (Rodriguez-Rubio et al., 2020)\n• Siltuximab for patients diagnosed with severe respiratory complications due to COVID-19\n• Anti-IL-6 mitigation of cytokine storm • Observational retrospective cohort study\n• Cohort A: continuous positive airway pressure followed by siltuximab\n• Cohort B: intubation followed by siltuximab\n• Control group receiving continuous positive airway pressure or intubation only\n• N = 220\n• Primary outcome of mortality over 30 days • Detailed siltuximab dosing regimen not specified.\n• Treatment procedure was based on clinicians judgement\n• Study completed May 8, 2020. 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, 2020)"}

LitCovid-PubTator

PMC:7534795 / 39597-46304 JSONTXT

Annnotations TAB JSON ListView MergeView

PMC:7534795 / 39597-46304 JSON TXT