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PubMed:32938496 JSONTXT 23 Projects

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Id Subject Object Predicate Lexical cue
T1 0-189 Sentence denotes Sarilumab versus standard of care for the early treatment of COVID-19 pneumonia in hospitalized patients: SARTRE: a structured summary of a study protocol for a randomised controlled trial.
T1 0-189 Sentence denotes Sarilumab versus standard of care for the early treatment of COVID-19 pneumonia in hospitalized patients: SARTRE: a structured summary of a study protocol for a randomised controlled trial.
T2 190-201 Sentence denotes OBJECTIVES:
T2 190-201 Sentence denotes OBJECTIVES:
T3 202-381 Sentence denotes In some patients, acute, life-threatening respiratory injury produced by viruses such as SARS-CoV and other viral pneumonia are associated with an over-exuberant cytokine release.
T3 202-381 Sentence denotes In some patients, acute, life-threatening respiratory injury produced by viruses such as SARS-CoV and other viral pneumonia are associated with an over-exuberant cytokine release.
T4 382-501 Sentence denotes Elevated levels of blood IL-6 had been identified as a one of the risk factors associated with severe COVID-19 disease.
T4 382-501 Sentence denotes Elevated levels of blood IL-6 had been identified as a one of the risk factors associated with severe COVID-19 disease.
T5 502-693 Sentence denotes Anti-IL6 inhibitors are among the therapeutic armamentarium for preventing the fatal consequences of acute respiratory and multi organ failure in around 20% of the COVID-19 infected patients.
T5 502-693 Sentence denotes Anti-IL6 inhibitors are among the therapeutic armamentarium for preventing the fatal consequences of acute respiratory and multi organ failure in around 20% of the COVID-19 infected patients.
T6 694-986 Sentence denotes At present, their use is prioritized to patients with severe interstitial pneumonia (Brescia-COVID Scale-COVID 2-3) with hyperinflammation as determined by the presence of elevated IL6 and/or d-dimer, or progressive d-dimer increase, in patients who otherwise are subsidiary to ICU admission.
T6 694-986 Sentence denotes At present, their use is prioritized to patients with severe interstitial pneumonia (Brescia-COVID Scale-COVID 2-3) with hyperinflammation as determined by the presence of elevated IL6 and/or d-dimer, or progressive d-dimer increase, in patients who otherwise are subsidiary to ICU admission.
T7 987-1133 Sentence denotes However, many uncertainties remain on the actual role of anti-IL6 inhibitors in this setting, and whether current use and timing is the right one.
T7 987-1133 Sentence denotes However, many uncertainties remain on the actual role of anti-IL6 inhibitors in this setting, and whether current use and timing is the right one.
T8 1134-1306 Sentence denotes There is the hypothesis that the use of anti-IL6 inhibitors at an earlier state during the hyperinflammatory syndrome would be beneficial and may avoid progressing to ARDS.
T8 1134-1306 Sentence denotes There is the hypothesis that the use of anti-IL6 inhibitors at an earlier state during the hyperinflammatory syndrome would be beneficial and may avoid progressing to ARDS.
T9 1307-1465 Sentence denotes On the other hand, the standard of care has changed and nowadays the use of corticosteroids has become part of the SOC in the treatment of COVID-19 pneumonia.
T9 1307-1465 Sentence denotes On the other hand, the standard of care has changed and nowadays the use of corticosteroids has become part of the SOC in the treatment of COVID-19 pneumonia.
T10 1466-1613 Sentence denotes Our limited experience suggests that better treatment outcomes can be achieved when combining IL6-inhibitors (e.g. sarilumab) with corticosteroids.
T10 1466-1613 Sentence denotes Our limited experience suggests that better treatment outcomes can be achieved when combining IL6-inhibitors (e.g. sarilumab) with corticosteroids.
T11 1614-1915 Sentence denotes The aim of the present study is to evaluate if an earlier therapeutic intervention with sarilumab plus SOC (including corticosteroids) may be more effective than current standard of care alone, in preventing progression to respiratory failure in COVID-19 infected patients with interstitial pneumonia.
T11 1614-1915 Sentence denotes The aim of the present study is to evaluate if an earlier therapeutic intervention with sarilumab plus SOC (including corticosteroids) may be more effective than current standard of care alone, in preventing progression to respiratory failure in COVID-19 infected patients with interstitial pneumonia.
T12 1916-2076 Sentence denotes This study will also provide supportive evidence to that provided by currently ongoing studies on the efficacy and safety of sarilumab in this clinical context.
T12 1916-2076 Sentence denotes This study will also provide supportive evidence to that provided by currently ongoing studies on the efficacy and safety of sarilumab in this clinical context.
T13 2077-2090 Sentence denotes TRIAL DESIGN:
T13 2077-2090 Sentence denotes TRIAL DESIGN:
T14 2091-2185 Sentence denotes A phase two multi-center randomised controlled trial (RCT) with two parallel arms (1:1 ratio).
T14 2091-2185 Sentence denotes A phase two multi-center randomised controlled trial (RCT) with two parallel arms (1:1 ratio).
T15 2186-2199 Sentence denotes PARTICIPANTS:
T15 2186-2199 Sentence denotes PARTICIPANTS:
T16 2200-2470 Sentence denotes They will be hospitalized patients, of at least 18 years of age, with severe COVID-19 who have positive RT-PCR test and have radiographic evidence of pulmonary infiltrates by imaging or rales/crackles on exam and SpO2 ≤ 94% on room air that requires supplemental oxygen.
T16 2200-2470 Sentence denotes They will be hospitalized patients, of at least 18 years of age, with severe COVID-19 who have positive RT-PCR test and have radiographic evidence of pulmonary infiltrates by imaging or rales/crackles on exam and SpO2 ≤ 94% on room air that requires supplemental oxygen.
T17 2471-2732 Sentence denotes Patients must present elevation of inflammatory parameters (IL-6 > 40 pg/mL or d-dimer >1.0 mcg/ml) or, alternatively, progressive worsening in at least two of these inflammatory parameters in the prior 24-48h: CRP, LDH, serum ferritin, lymphopenia, or d-dimer.
T17 2471-2732 Sentence denotes Patients must present elevation of inflammatory parameters (IL-6 > 40 pg/mL or d-dimer >1.0 mcg/ml) or, alternatively, progressive worsening in at least two of these inflammatory parameters in the prior 24-48h: CRP, LDH, serum ferritin, lymphopenia, or d-dimer.
T18 2733-3283 Sentence denotes EXCLUSION CRITERIA: high oxygen requirements (including face mask with reservoir, non-invasive mechanical ventilation or high flow nasal cannula, or mechanical ventilation), admission to ICU, pregnancy or lactation, allergy or hypersensitivity to sarilumab or corticoesteroids, immunosuppressive antibody therapy within the past 5 months, AST/ALT values > 10 x ULN, neutropenia (< 0.5 x 109/L), severe thrombocytopenia (< 50 x 109/L), sepsis caused by an alternative pathogen, diverticulitis with risk of perforation or ongoing infectious dermatitis.
T18 2733-3283 Sentence denotes EXCLUSION CRITERIA: high oxygen requirements (including face mask with reservoir, non-invasive mechanical ventilation or high flow nasal cannula, or mechanical ventilation), admission to ICU, pregnancy or lactation, allergy or hypersensitivity to sarilumab or corticoesteroids, immunosuppressive antibody therapy within the past 5 months, AST/ALT values > 10 x ULN, neutropenia (< 0.5 x 109/L), severe thrombocytopenia (< 50 x 109/L), sepsis caused by an alternative pathogen, diverticulitis with risk of perforation or ongoing infectious dermatitis.
T19 3284-3342 Sentence denotes The study will be conducted in several hospitals in Spain.
T19 3284-3342 Sentence denotes The study will be conducted in several hospitals in Spain.
T20 3343-3371 Sentence denotes INTERVENTION AND COMPARATOR:
T20 3343-3371 Sentence denotes INTERVENTION AND COMPARATOR:
T21 3372-3482 Sentence denotes Patients randomised to the experimental arm will receive sarilumab + methylprednisolone plus SOC for COVID-19.
T21 3372-3482 Sentence denotes Patients randomised to the experimental arm will receive sarilumab + methylprednisolone plus SOC for COVID-19.
T22 3483-3574 Sentence denotes Patients included in the control arm will receive methylprednisolone plus SOC for COVID-19.
T22 3483-3574 Sentence denotes Patients included in the control arm will receive methylprednisolone plus SOC for COVID-19.
T23 3575-3677 Sentence denotes Corticosteroids will be given to all patients at a 1mg/kg/d of methylprednisolone for at least 3 days.
T23 3575-3677 Sentence denotes Corticosteroids will be given to all patients at a 1mg/kg/d of methylprednisolone for at least 3 days.
T24 3678-3773 Sentence denotes Clinical follow-up visits will be performed at 3, 5, and 15 days after treatment randomization.
T24 3678-3773 Sentence denotes Clinical follow-up visits will be performed at 3, 5, and 15 days after treatment randomization.
T25 3774-4133 Sentence denotes Patients in the control group (SOC group without sarilumab) progressing to Brescia- COVID 2-3 plus inflammatory markers, will be given the option to be rescued with sarilumab at the same doses and, in that case, be included in an open-label phase and be followed up for additional weeks (with visits at 3, 7 and 15 days after sarilumab rescue administration).
T25 3774-4133 Sentence denotes Patients in the control group (SOC group without sarilumab) progressing to Brescia- COVID 2-3 plus inflammatory markers, will be given the option to be rescued with sarilumab at the same doses and, in that case, be included in an open-label phase and be followed up for additional weeks (with visits at 3, 7 and 15 days after sarilumab rescue administration).
T26 4134-4290 Sentence denotes Patients randomly assigned to sarilumab therapy at baseline progressing to Brescia-COVID 2-3 will be rescued according to local clinical practice protocols.
T26 4134-4290 Sentence denotes Patients randomly assigned to sarilumab therapy at baseline progressing to Brescia-COVID 2-3 will be rescued according to local clinical practice protocols.
T27 4291-4423 Sentence denotes A final follow-up visit will be conducted for all patients at day 29 from randomization, regardless of initial treatment assignment.
T27 4291-4423 Sentence denotes A final follow-up visit will be conducted for all patients at day 29 from randomization, regardless of initial treatment assignment.
T28 4424-4438 Sentence denotes MAIN OUTCOMES:
T28 4424-4438 Sentence denotes MAIN OUTCOMES:
T29 4439-4580 Sentence denotes Primary end point is the proportion of patients progressing to either severe respiratory failure (Brescia-COVID ≥2), ICU admission, or death.
T29 4439-4580 Sentence denotes Primary end point is the proportion of patients progressing to either severe respiratory failure (Brescia-COVID ≥2), ICU admission, or death.
T30 4581-4595 Sentence denotes RANDOMIZATION:
T30 4581-4595 Sentence denotes RANDOMIZATION:
T31 4596-4766 Sentence denotes Randomization codes were produced by means of the PROC PLAN of the SAS system, with a 1:1 assignment ratio, stratifying by centre and using blocks multiple of 2 elements.
T31 4596-4766 Sentence denotes Randomization codes were produced by means of the PROC PLAN of the SAS system, with a 1:1 assignment ratio, stratifying by centre and using blocks multiple of 2 elements.
T32 4767-4849 Sentence denotes The randomization schedule will be managed through the eCRF in a concealed manner.
T32 4767-4849 Sentence denotes The randomization schedule will be managed through the eCRF in a concealed manner.
T33 4850-4869 Sentence denotes BLINDING (MASKING):
T33 4850-4869 Sentence denotes BLINDING (MASKING):
T34 4870-4921 Sentence denotes All study drugs will be administered as open label.
T34 4870-4921 Sentence denotes All study drugs will be administered as open label.
T35 4922-4969 Sentence denotes No blinding methods will be used in this trial.
T35 4922-4969 Sentence denotes No blinding methods will be used in this trial.
T36 4970-5009 Sentence denotes NUMBERS TO BE RANDOMISED (SIMPLE SIZE):
T36 4970-5009 Sentence denotes NUMBERS TO BE RANDOMISED (SIMPLE SIZE):
T37 5010-5140 Sentence denotes The target sample size will be 200 COVID-19 patients, who will be allocated randomly to control arm (100) and treatment arm (100).
T37 5010-5140 Sentence denotes The target sample size will be 200 COVID-19 patients, who will be allocated randomly to control arm (100) and treatment arm (100).
T38 5141-5154 Sentence denotes TRIAL STATUS:
T38 5141-5154 Sentence denotes TRIAL STATUS:
T39 5155-5191 Sentence denotes Protocol Code: SARTRE Protocol Date:
T39 5155-5191 Sentence denotes Protocol Code: SARTRE Protocol Date:
T40 5192-5206 Sentence denotes May 05th 2020.
T40 5192-5206 Sentence denotes May 05th 2020.
T41 5207-5215 Sentence denotes Version:
T41 5207-5215 Sentence denotes Version:
T42 5216-5328 Sentence denotes 2.0 The study has been approved by the Spanish Competent Authority (AEMPS) as a low intervention clinical trial.
T42 5216-5328 Sentence denotes 2.0 The study has been approved by the Spanish Competent Authority (AEMPS) as a low intervention clinical trial.
T43 5329-5350 Sentence denotes Start of recruitment:
T43 5329-5350 Sentence denotes Start of recruitment:
T44 5351-5383 Sentence denotes August, 2020 End of recruitment:
T44 5351-5383 Sentence denotes August, 2020 End of recruitment:
T45 5384-5413 Sentence denotes May, 2021 TRIAL REGISTRATION:
T45 5384-5413 Sentence denotes May, 2021 TRIAL REGISTRATION:
T46 5414-5425 Sentence denotes Identifier:
T46 5414-5425 Sentence denotes Identifier:
T47 5426-5441 Sentence denotes EudraCT Number:
T47 5426-5441 Sentence denotes EudraCT Number:
T48 5442-5477 Sentence denotes 2020-002037-15 ; Registration date:
T48 5442-5477 Sentence denotes 2020-002037-15 ; Registration date:
T49 5478-5490 Sentence denotes 26 May 2020.
T49 5478-5490 Sentence denotes 26 May 2020.
T50 5491-5505 Sentence denotes FULL PROTOCOL:
T50 5491-5505 Sentence denotes FULL PROTOCOL:
T51 5506-5614 Sentence denotes The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1).
T51 5506-5614 Sentence denotes The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1).
T52 5615-5795 Sentence denotes In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this letter serves as a summary of the key elements of the full protocol.
T52 5615-5795 Sentence denotes In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this letter serves as a summary of the key elements of the full protocol.
T53 5796-5880 Sentence denotes The study protocol has been reported in accordance with the Standard Protocol Items:
T53 5796-5880 Sentence denotes The study protocol has been reported in accordance with the Standard Protocol Items:
T54 5881-5972 Sentence denotes Recommendations for Clinical Interventional Trials (SPIRIT) guidelines (Additional file 2).
T54 5881-5972 Sentence denotes Recommendations for Clinical Interventional Trials (SPIRIT) guidelines (Additional file 2).