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PubMed:33115543 JSONTXT 2 Projects

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Id Subject Object Predicate Lexical cue
T1 0-70 Sentence denotes Safety and Efficacy of Imatinib for Hospitalized Adults with COVID-19:
T1 0-70 Sentence denotes Safety and Efficacy of Imatinib for Hospitalized Adults with COVID-19:
T2 71-146 Sentence denotes A structured summary of a study protocol for a randomised controlled trial.
T2 71-146 Sentence denotes A structured summary of a study protocol for a randomised controlled trial.
T3 147-158 Sentence denotes OBJECTIVES:
T3 147-158 Sentence denotes OBJECTIVES:
T4 159-177 Sentence denotes Primary Objective:
T4 159-177 Sentence denotes Primary Objective:
T5 178-359 Sentence denotes To evaluate the efficacy and safety of oral administration of imatinib combined with the Best Conventional Care (BCC) versus placebo plus BCC in hospitalized patients with COVID-19.
T5 178-359 Sentence denotes To evaluate the efficacy and safety of oral administration of imatinib combined with the Best Conventional Care (BCC) versus placebo plus BCC in hospitalized patients with COVID-19.
T6 360-371 Sentence denotes HYPOTHESIS:
T6 360-371 Sentence denotes HYPOTHESIS:
T7 372-503 Sentence denotes Addition of imatinib to the BCC will provide a superior clinical outcome for patients with COVID-19 compared with BCC plus placebo.
T7 372-503 Sentence denotes Addition of imatinib to the BCC will provide a superior clinical outcome for patients with COVID-19 compared with BCC plus placebo.
T8 504-985 Sentence denotes This hypothesis is on the basis of 1) intralysosomal entrapment of imatinib will increase endosomal pH and effectively decrease SARS-CoV-2/cell fusion, 2) kinase inhibitory activity of imatinib will interfere with budding/release or replication of SARS-CoV-2, and 3) because of the critical role of mechanical ventilation in the care of patients with ARDS, imatinib will have a significant clinical impact for patients with critical COVID-19 infection in Intensive Care Unit (ICU).
T8 504-985 Sentence denotes This hypothesis is on the basis of 1) intralysosomal entrapment of imatinib will increase endosomal pH and effectively decrease SARS-CoV-2/cell fusion, 2) kinase inhibitory activity of imatinib will interfere with budding/release or replication of SARS-CoV-2, and 3) because of the critical role of mechanical ventilation in the care of patients with ARDS, imatinib will have a significant clinical impact for patients with critical COVID-19 infection in Intensive Care Unit (ICU).
T9 986-999 Sentence denotes TRIAL DESIGN:
T9 986-999 Sentence denotes TRIAL DESIGN:
T10 1000-1216 Sentence denotes This is an individual patient-level randomized, double-blind, placebo-controlled, two-parallel arm phase 3 study to evaluate the safety and efficacy of imatinib for the treatment of hospitalized adults with COVID-19.
T10 1000-1216 Sentence denotes This is an individual patient-level randomized, double-blind, placebo-controlled, two-parallel arm phase 3 study to evaluate the safety and efficacy of imatinib for the treatment of hospitalized adults with COVID-19.
T11 1217-1309 Sentence denotes Participants will be followed for up to 60 days from the start of study drug administration.
T11 1217-1309 Sentence denotes Participants will be followed for up to 60 days from the start of study drug administration.
T12 1310-1495 Sentence denotes This trial will be conducted in accordance with the principles of the Declaration of Helsinki and the Good Clinical Practice guidelines of the International Conference on Harmonization.
T12 1310-1495 Sentence denotes This trial will be conducted in accordance with the principles of the Declaration of Helsinki and the Good Clinical Practice guidelines of the International Conference on Harmonization.
T13 1496-1509 Sentence denotes PARTICIPANTS:
T13 1496-1509 Sentence denotes PARTICIPANTS:
T14 1510-1529 Sentence denotes Inclusion Criteria:
T14 1510-1529 Sentence denotes Inclusion Criteria:
T15 1530-1616 Sentence denotes Patients may be included in the study only if they meet all of the following criteria:
T15 1530-1616 Sentence denotes Patients may be included in the study only if they meet all of the following criteria:
T16 1617-1702 Sentence denotes 1) Ability to understand and willingness to sign a written informed consent document.
T16 1617-1702 Sentence denotes 1) Ability to understand and willingness to sign a written informed consent document.
T17 1703-1773 Sentence denotes Informed consent must be obtained prior to participation in the study.
T17 1703-1773 Sentence denotes Informed consent must be obtained prior to participation in the study.
T18 1774-2426 Sentence denotes For patients who are too unwell to provide consent such as patients on invasive ventilator or extracorporeal membrane oxygenation (ECMO), their Legally Authorized Representative (LAR) can sign the informed consent, 2) Hospitalized patients ≥18 years of age, 3) Positive reverse transcriptase-polymerase chain reaction (RT-PCR) assay for SARS-CoV-2 in the respiratory tract sample (oropharyngeal, nasopharyngeal or bronchoalveolar lavage (BAL)) by Center for Disease Control or local laboratory within 7 days of randomization, 4) Women of childbearing potential must agree to use at least one primary form of contraception for the duration of the study.
T18 1774-2426 Sentence denotes For patients who are too unwell to provide consent such as patients on invasive ventilator or extracorporeal membrane oxygenation (ECMO), their Legally Authorized Representative (LAR) can sign the informed consent, 2) Hospitalized patients ≥18 years of age, 3) Positive reverse transcriptase-polymerase chain reaction (RT-PCR) assay for SARS-CoV-2 in the respiratory tract sample (oropharyngeal, nasopharyngeal or bronchoalveolar lavage (BAL)) by Center for Disease Control or local laboratory within 7 days of randomization, 4) Women of childbearing potential must agree to use at least one primary form of contraception for the duration of the study.
T19 2427-2446 Sentence denotes EXCLUSION CRITERIA:
T19 2427-2446 Sentence denotes EXCLUSION CRITERIA:
T20 2447-2525 Sentence denotes Patients meeting any of the following criteria are not eligible for the study:
T20 2447-2525 Sentence denotes Patients meeting any of the following criteria are not eligible for the study:
T21 2526-2601 Sentence denotes 1) Patients receiving any other investigational agents in a clinical trial.
T21 2526-2601 Sentence denotes 1) Patients receiving any other investigational agents in a clinical trial.
T22 2602-2815 Sentence denotes Off-label use of agents such as hydroxychloroquine is not an exclusion criterion, 2) Pregnant or breastfeeding women, 3) Patients with significant liver or renal dysfunction at the time of screening as defined as:
T22 2602-2815 Sentence denotes Off-label use of agents such as hydroxychloroquine is not an exclusion criterion, 2) Pregnant or breastfeeding women, 3) Patients with significant liver or renal dysfunction at the time of screening as defined as:
T23 2816-3051 Sentence denotes 3.1) Direct bilirubin >2.5 mg/dL, 3.2) AST, ALT, or alkaline phosphatase >5x upper limit of normal, 3.3) eGFR ≤30 mL/min or requiring renal replacement therapy, 4) Patients with significant hematologic disorder at screen as defined as:
T23 2816-3051 Sentence denotes 3.1) Direct bilirubin >2.5 mg/dL, 3.2) AST, ALT, or alkaline phosphatase >5x upper limit of normal, 3.3) eGFR ≤30 mL/min or requiring renal replacement therapy, 4) Patients with significant hematologic disorder at screen as defined as:
T24 3052-3631 Sentence denotes 4.1) Absolute neutrophil count (ANC) <500/μL, 4.2) Platelet <20,000/μL, 4.3) Hemoglobin <7 g/dL, 5) Uncontrolled underlying illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled active seizure disorder, or psychiatric illness/social situations that per site Principal Investigator's judgment would limit compliance with study requirements, 6) Known allergy to imatinib or its component products, 7) Any other clinical conditions that in the opinion of the investigator would make the subject unsuitable for the study.
T24 3052-3631 Sentence denotes 4.1) Absolute neutrophil count (ANC) <500/μL, 4.2) Platelet <20,000/μL, 4.3) Hemoglobin <7 g/dL, 5) Uncontrolled underlying illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled active seizure disorder, or psychiatric illness/social situations that per site Principal Investigator's judgment would limit compliance with study requirements, 6) Known allergy to imatinib or its component products, 7) Any other clinical conditions that in the opinion of the investigator would make the subject unsuitable for the study.
T25 3632-3710 Sentence denotes Both men and women of all races and ethnic groups are eligible for this trial.
T25 3632-3710 Sentence denotes Both men and women of all races and ethnic groups are eligible for this trial.
T26 3711-3787 Sentence denotes University of Maryland Medical Center, Baltimore, MD is the initiating site.
T26 3711-3787 Sentence denotes University of Maryland Medical Center, Baltimore, MD is the initiating site.
T27 3788-3904 Sentence denotes The study may be opened in other centers on the basis of the accrual rate or the magnitude of the COVID-19 pandemic.
T27 3788-3904 Sentence denotes The study may be opened in other centers on the basis of the accrual rate or the magnitude of the COVID-19 pandemic.
T28 3905-3933 Sentence denotes INTERVENTION AND COMPARATOR:
T28 3905-3933 Sentence denotes INTERVENTION AND COMPARATOR:
T29 3934-3943 Sentence denotes Imatinib:
T29 3934-3943 Sentence denotes Imatinib:
T30 3944-4028 Sentence denotes All doses of imatinib should be administered with a meal and a large glass of water.
T30 3944-4028 Sentence denotes All doses of imatinib should be administered with a meal and a large glass of water.
T31 4029-4121 Sentence denotes Imatinib can be dissolved in water or apple juice for patients having difficulty swallowing.
T31 4029-4121 Sentence denotes Imatinib can be dissolved in water or apple juice for patients having difficulty swallowing.
T32 4122-4256 Sentence denotes In this study, patients with confirmed positive COVID-19 tests receive imatinib for a total of 14 days; 400 mg orally daily Days 1-14.
T32 4122-4256 Sentence denotes In this study, patients with confirmed positive COVID-19 tests receive imatinib for a total of 14 days; 400 mg orally daily Days 1-14.
T33 4257-4364 Sentence denotes Imatinib 400 mg tablets will be encapsulated using size 000 capsules and cellulose microcrystalline filler.
T33 4257-4364 Sentence denotes Imatinib 400 mg tablets will be encapsulated using size 000 capsules and cellulose microcrystalline filler.
T34 4365-4454 Sentence denotes For patients on ventilator or ECMO, imatinib will be given as oral suspension (40 mg/mL).
T34 4365-4454 Sentence denotes For patients on ventilator or ECMO, imatinib will be given as oral suspension (40 mg/mL).
T35 4455-4609 Sentence denotes To make the oral suspension, imatinib tablets will be crushed and mixed in Ora-sweet solution to yield a concentration of 40 mg/mL suspension by pharmacy.
T35 4455-4609 Sentence denotes To make the oral suspension, imatinib tablets will be crushed and mixed in Ora-sweet solution to yield a concentration of 40 mg/mL suspension by pharmacy.
T36 4610-4842 Sentence denotes Additionally, in the absence of supportive microbiological testing results, we confirm that the in-use stability period for the prepared imatinib suspensions will be 24 hours at room temperature or 7 days at refrigerated conditions.
T36 4610-4842 Sentence denotes Additionally, in the absence of supportive microbiological testing results, we confirm that the in-use stability period for the prepared imatinib suspensions will be 24 hours at room temperature or 7 days at refrigerated conditions.
T37 4843-4968 Sentence denotes The pharmacy staff will follow the American Society Health-System Pharmacists (ASHP) guidelines for handling hazardous drugs.
T37 4843-4968 Sentence denotes The pharmacy staff will follow the American Society Health-System Pharmacists (ASHP) guidelines for handling hazardous drugs.
T38 4969-4977 Sentence denotes Placebo:
T38 4969-4977 Sentence denotes Placebo:
T39 4978-5098 Sentence denotes The matching placebo will be packaged by Investigational Drug Service Pharmacy at University of Maryland Medical Center.
T39 4978-5098 Sentence denotes The matching placebo will be packaged by Investigational Drug Service Pharmacy at University of Maryland Medical Center.
T40 5099-5191 Sentence denotes The placebos will be prepared using size 000 capsules and cellulose microcrystalline filler.
T40 5099-5191 Sentence denotes The placebos will be prepared using size 000 capsules and cellulose microcrystalline filler.
T41 5192-5271 Sentence denotes Imatinib 400 mg capsules and placebo capsules will be identical form and color.
T41 5192-5271 Sentence denotes Imatinib 400 mg capsules and placebo capsules will be identical form and color.
T42 5272-5401 Sentence denotes For patients on ventilator or ECMO, placebo will be given as oral suspension with similar process for making imatinib suspension.
T42 5272-5401 Sentence denotes For patients on ventilator or ECMO, placebo will be given as oral suspension with similar process for making imatinib suspension.
T43 5402-5442 Sentence denotes Concomitant Medications/supportive care:
T43 5402-5442 Sentence denotes Concomitant Medications/supportive care:
T44 5443-5685 Sentence denotes In both arms, patients can receive concomitant available local standard of care antipyretics, antibacterials, antivirals, antifungals and anti-inflammatory including hydroxychloroquine at the discretion of the treating physician as necessary.
T44 5443-5685 Sentence denotes In both arms, patients can receive concomitant available local standard of care antipyretics, antibacterials, antivirals, antifungals and anti-inflammatory including hydroxychloroquine at the discretion of the treating physician as necessary.
T45 5686-5861 Sentence denotes For other drug-drug interactions particularly with CYP P450, the treating physician should consider the risk and benefit of drug administration based on available information.
T45 5686-5861 Sentence denotes For other drug-drug interactions particularly with CYP P450, the treating physician should consider the risk and benefit of drug administration based on available information.
T46 5862-6097 Sentence denotes Co-administration of off-label immunomodulatory treatments for COVID-19 including but not limited to corticosteroids, sarilumab, clazakizumab, tocilizumab, and anakinra will be allowed but may affect interpretability of study outcomes.
T46 5862-6097 Sentence denotes Co-administration of off-label immunomodulatory treatments for COVID-19 including but not limited to corticosteroids, sarilumab, clazakizumab, tocilizumab, and anakinra will be allowed but may affect interpretability of study outcomes.
T47 6098-6321 Sentence denotes The timing, dosing, and duration of these treatments will be meticulously collected, including any of these treatments that may be used for participants who experience progression of COVID-19 disease after study enrollment.
T47 6098-6321 Sentence denotes The timing, dosing, and duration of these treatments will be meticulously collected, including any of these treatments that may be used for participants who experience progression of COVID-19 disease after study enrollment.
T48 6322-6555 Sentence denotes Two analyses will be performed, the primary analysis will compare the primary endpoint in the two trial arms irrespective of any other treatment; the second analysis will be stratified for co-administration of immunomodulatory drugs.
T48 6322-6555 Sentence denotes Two analyses will be performed, the primary analysis will compare the primary endpoint in the two trial arms irrespective of any other treatment; the second analysis will be stratified for co-administration of immunomodulatory drugs.
T49 6556-6570 Sentence denotes MAIN OUTCOMES:
T49 6556-6570 Sentence denotes MAIN OUTCOMES:
T50 6571-6710 Sentence denotes The primary endpoint is the proportion of patients with a two-point improvement at Day 14 from baseline using the 8-category ordinal scale.
T50 6571-6710 Sentence denotes The primary endpoint is the proportion of patients with a two-point improvement at Day 14 from baseline using the 8-category ordinal scale.
T51 6711-6814 Sentence denotes The ordinal scale is an evaluation of the clinical status at the first assessment of a given study day.
T51 6711-6814 Sentence denotes The ordinal scale is an evaluation of the clinical status at the first assessment of a given study day.
T52 6815-6839 Sentence denotes The scale is as follows:
T52 6815-6839 Sentence denotes The scale is as follows:
T53 6840-7370 Sentence denotes 1) Not hospitalized, no limitations on activities; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5) Hospitalized, requiring supplemental oxygen; 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 7) Hospitalized, on invasive mechanical ventilation or ECMO; 8) Death.
T53 6840-7370 Sentence denotes 1) Not hospitalized, no limitations on activities; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5) Hospitalized, requiring supplemental oxygen; 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 7) Hospitalized, on invasive mechanical ventilation or ECMO; 8) Death.
T54 7371-7403 Sentence denotes The secondary endpoints include:
T54 7371-7403 Sentence denotes The secondary endpoints include:
T55 7404-8058 Sentence denotes All-cause mortality at Day 28, All-cause mortality at Day 60, Time to a 2-point clinical improvement difference over baseline, Duration of hospitalization, Duration of ECMO or invasive mechanical ventilation (for subjects who are on ECMO or mechanical ventilation at Day 1), Duration of ICU stay (for subjects who are in ICU at Day 1), Time to SARS-CoV-2 negative by RT-PCR, Proportion of patients with negative oropharyngeal or nasopharyngeal swab for SARS-CoV-2 by RT-PCR on days 5, 10, 14, 21, and 28 after starting treatment, Proportion of subjects with serious adverse events, Proportion of subjects who discontinue study drug due to adverse events.
T55 7404-8058 Sentence denotes All-cause mortality at Day 28, All-cause mortality at Day 60, Time to a 2-point clinical improvement difference over baseline, Duration of hospitalization, Duration of ECMO or invasive mechanical ventilation (for subjects who are on ECMO or mechanical ventilation at Day 1), Duration of ICU stay (for subjects who are in ICU at Day 1), Time to SARS-CoV-2 negative by RT-PCR, Proportion of patients with negative oropharyngeal or nasopharyngeal swab for SARS-CoV-2 by RT-PCR on days 5, 10, 14, 21, and 28 after starting treatment, Proportion of subjects with serious adverse events, Proportion of subjects who discontinue study drug due to adverse events.
T56 8059-8093 Sentence denotes The exploratory endpoints include:
T56 8059-8093 Sentence denotes The exploratory endpoints include:
T57 8094-8630 Sentence denotes Determine the impact of treatment arms on IL-6 levels, Obtain blood/peripheral blood mononuclear cells (PBMCs) for storage to look at transcriptomics in severe disease, Association of major histocompatibility complex (MHC) with severity of illness, Mean change in the ordinal scale from baseline, Time to an improvement of one category from admission using an ordinal scale, Duration of hospitalization, Duration of new oxygen use, Number of oxygenation free days, Duration of new mechanical ventilation, Number of ventilator free days.
T57 8094-8630 Sentence denotes Determine the impact of treatment arms on IL-6 levels, Obtain blood/peripheral blood mononuclear cells (PBMCs) for storage to look at transcriptomics in severe disease, Association of major histocompatibility complex (MHC) with severity of illness, Mean change in the ordinal scale from baseline, Time to an improvement of one category from admission using an ordinal scale, Duration of hospitalization, Duration of new oxygen use, Number of oxygenation free days, Duration of new mechanical ventilation, Number of ventilator free days.
T58 8631-8645 Sentence denotes RANDOMIZATION:
T58 8631-8645 Sentence denotes RANDOMIZATION:
T59 8646-8756 Sentence denotes Eligible patients will be uniformly randomized in 1:1 ratio to receive either imatinib or placebo for 14 days.
T59 8646-8756 Sentence denotes Eligible patients will be uniformly randomized in 1:1 ratio to receive either imatinib or placebo for 14 days.
T60 8757-8790 Sentence denotes Both groups will receive the BCC.
T60 8757-8790 Sentence denotes Both groups will receive the BCC.
T61 8791-8964 Sentence denotes The randomized treatment allocations use stratified, permuted block randomization with a variable block size; blocks are generated using a validated random number generator.
T61 8791-8964 Sentence denotes The randomized treatment allocations use stratified, permuted block randomization with a variable block size; blocks are generated using a validated random number generator.
T62 8965-9135 Sentence denotes In order to balance the severity of the respiratory illness between the two arms, randomization will be stratified based on radiographic findings and oxygen requirements:
T62 8965-9135 Sentence denotes In order to balance the severity of the respiratory illness between the two arms, randomization will be stratified based on radiographic findings and oxygen requirements:
T63 9136-9702 Sentence denotes 1) Severe disease: evidence of pneumonia on chest X-ray or CT scan OR chest auscultation (rales, crackles), and SpO2 ≤92% on ambient air or PaO2/FiO2 <300 mmHg, and requires supplemental oxygen administration by nasal cannula, simple face mask, or other similar oxygen delivery device; 2) Critical disease: requires supplemental oxygen delivered by non-rebreather mask or high flow cannula OR use of invasive or non-invasive ventilation OR requiring treatment in an intensive care unit, use of vasopressors, extracorporeal life support, or renal replacement therapy.
T63 9136-9702 Sentence denotes 1) Severe disease: evidence of pneumonia on chest X-ray or CT scan OR chest auscultation (rales, crackles), and SpO2 ≤92% on ambient air or PaO2/FiO2 <300 mmHg, and requires supplemental oxygen administration by nasal cannula, simple face mask, or other similar oxygen delivery device; 2) Critical disease: requires supplemental oxygen delivered by non-rebreather mask or high flow cannula OR use of invasive or non-invasive ventilation OR requiring treatment in an intensive care unit, use of vasopressors, extracorporeal life support, or renal replacement therapy.
T64 9703-9722 Sentence denotes BLINDING (MASKING):
T64 9703-9722 Sentence denotes BLINDING (MASKING):
T65 9723-9806 Sentence denotes The participants, caregivers, and the statistician are blinded to group assignment.
T65 9723-9806 Sentence denotes The participants, caregivers, and the statistician are blinded to group assignment.
T66 9807-9864 Sentence denotes The only people who are not blinded are Site Pharmacists.
T66 9807-9864 Sentence denotes The only people who are not blinded are Site Pharmacists.
T67 9865-9929 Sentence denotes Blinding will be performed via a specific randomization process.
T67 9865-9929 Sentence denotes Blinding will be performed via a specific randomization process.
T68 9930-10017 Sentence denotes Centralized, concealed randomization will be executed by the Primary Site's Pharmacist.
T68 9930-10017 Sentence denotes Centralized, concealed randomization will be executed by the Primary Site's Pharmacist.
T69 10018-10189 Sentence denotes Data on eligible consented cases will be submitted electronically on the appropriate on-study form to the pharmacy, where the patient is randomized to imatinib or placebo.
T69 10018-10189 Sentence denotes Data on eligible consented cases will be submitted electronically on the appropriate on-study form to the pharmacy, where the patient is randomized to imatinib or placebo.
T70 10190-10269 Sentence denotes Imatinib 400 mg capsules and placebo capsules will be identical form and color.
T70 10190-10269 Sentence denotes Imatinib 400 mg capsules and placebo capsules will be identical form and color.
T71 10270-10399 Sentence denotes For patients on ventilator or ECMO, placebo will be given as oral suspension with similar process for making imatinib suspension.
T71 10270-10399 Sentence denotes For patients on ventilator or ECMO, placebo will be given as oral suspension with similar process for making imatinib suspension.
T72 10400-10439 Sentence denotes NUMBERS TO BE RANDOMIZED (SAMPLE SIZE):
T72 10400-10439 Sentence denotes NUMBERS TO BE RANDOMIZED (SAMPLE SIZE):
T73 10440-10568 Sentence denotes The trial is designed as a double-blind, two-parallel arm, randomized controlled trial with a uniform (1:1) allocation ratio to:
T73 10440-10568 Sentence denotes The trial is designed as a double-blind, two-parallel arm, randomized controlled trial with a uniform (1:1) allocation ratio to:
T74 10569-10603 Sentence denotes Arm A) Imatinib or Arm B) Placebo.
T74 10569-10603 Sentence denotes Arm A) Imatinib or Arm B) Placebo.
T75 10604-10725 Sentence denotes Patients in both arms will receive the BCC per local institutional standards at the discretion of the treating physician.
T75 10604-10725 Sentence denotes Patients in both arms will receive the BCC per local institutional standards at the discretion of the treating physician.
T76 10726-10859 Sentence denotes Group sample sizes of 102 in Arm A and 102 in Arm B achieve 80.6% power to detect a difference between the group proportions of 0.20.
T76 10726-10859 Sentence denotes Group sample sizes of 102 in Arm A and 102 in Arm B achieve 80.6% power to detect a difference between the group proportions of 0.20.
T77 10860-10999 Sentence denotes The proportion in Arm A (imatinib treatment arm) is assumed to be 0.30 under the null hypothesis and 0.50 under the alternative hypothesis.
T77 10860-10999 Sentence denotes The proportion in Arm A (imatinib treatment arm) is assumed to be 0.30 under the null hypothesis and 0.50 under the alternative hypothesis.
T78 11000-11054 Sentence denotes The proportion in Arm B (placebo control arm) is 0.30.
T78 11000-11054 Sentence denotes The proportion in Arm B (placebo control arm) is 0.30.
T79 11055-11116 Sentence denotes The test statistic used is the two-sided Fisher's Exact Test.
T79 11055-11116 Sentence denotes The test statistic used is the two-sided Fisher's Exact Test.
T80 11117-11172 Sentence denotes The significance level of the test is targeted at 0.05.
T80 11117-11172 Sentence denotes The significance level of the test is targeted at 0.05.
T81 11173-11241 Sentence denotes The significance level actually achieved by this design is α=0.0385.
T81 11173-11241 Sentence denotes The significance level actually achieved by this design is α=0.0385.
T82 11242-11330 Sentence denotes The power of the test is calculated using binomial enumeration of all possible outcomes.
T82 11242-11330 Sentence denotes The power of the test is calculated using binomial enumeration of all possible outcomes.
T83 11331-11486 Sentence denotes The primary analysis will be conducted using an intention to treat principle (ITT) for participants who at least receive one dose of study drug or placebo.
T83 11331-11486 Sentence denotes The primary analysis will be conducted using an intention to treat principle (ITT) for participants who at least receive one dose of study drug or placebo.
T84 11487-11532 Sentence denotes The sample size is not inflated for dropouts.
T84 11487-11532 Sentence denotes The sample size is not inflated for dropouts.
T85 11533-11617 Sentence denotes All patients will be evaluable irrespective of the clinical course of their disease.
T85 11533-11617 Sentence denotes All patients will be evaluable irrespective of the clinical course of their disease.
T86 11618-11631 Sentence denotes TRIAL STATUS:
T86 11618-11631 Sentence denotes TRIAL STATUS:
T87 11632-11681 Sentence denotes Current protocol version is 1.2 from May 8, 2020.
T87 11632-11681 Sentence denotes Current protocol version is 1.2 from May 8, 2020.
T88 11682-11738 Sentence denotes The recruitment started on June 15, 2020 and is ongoing.
T88 11682-11738 Sentence denotes The recruitment started on June 15, 2020 and is ongoing.
T89 11739-11817 Sentence denotes We originally anticipated that the trial would finish recruitment by mid 2021.
T89 11739-11817 Sentence denotes We originally anticipated that the trial would finish recruitment by mid 2021.
T90 11818-11957 Sentence denotes We are aware of the enrollment requirement of approximately 200 patients, which is required to provide scientific integrity of the results.
T90 11818-11957 Sentence denotes We are aware of the enrollment requirement of approximately 200 patients, which is required to provide scientific integrity of the results.
T91 11958-12179 Sentence denotes We are also aware of the fact that enrolling this number of patients in a single-site at University of Maryland Medical Center (UMMC) may take longer than expected, particularly taken into account other competing studies.
T91 11958-12179 Sentence denotes We are also aware of the fact that enrolling this number of patients in a single-site at University of Maryland Medical Center (UMMC) may take longer than expected, particularly taken into account other competing studies.
T92 12180-12261 Sentence denotes For this reason, we are actively considering opening the protocol in other sites.
T92 12180-12261 Sentence denotes For this reason, we are actively considering opening the protocol in other sites.
T93 12262-12386 Sentence denotes After identification of other sites, we will fulfill all regulatory requirements before opening the protocol in other sites.
T93 12262-12386 Sentence denotes After identification of other sites, we will fulfill all regulatory requirements before opening the protocol in other sites.
T94 12387-12406 Sentence denotes TRIAL REGISTRATION:
T94 12387-12406 Sentence denotes TRIAL REGISTRATION:
T95 12407-12451 Sentence denotes ClinicalTrials.gov Identifier: NCT04394416 .
T95 12407-12451 Sentence denotes ClinicalTrials.gov Identifier: NCT04394416 .
T96 12452-12465 Sentence denotes First Posted:
T96 12452-12465 Sentence denotes First Posted:
T97 12466-12499 Sentence denotes May 19, 2020; Last Update Posted:
T97 12466-12499 Sentence denotes May 19, 2020; Last Update Posted:
T98 12500-12513 Sentence denotes June 4, 2020.
T98 12500-12513 Sentence denotes June 4, 2020.
T99 12514-12639 Sentence denotes FDA has issued the "Study May Proceed" Letter for this clinical trial under the Investigational New Drug (IND) number 149239.
T99 12514-12639 Sentence denotes FDA has issued the "Study May Proceed" Letter for this clinical trial under the Investigational New Drug (IND) number 149239.
T100 12640-12654 Sentence denotes FULL PROTOCOL:
T100 12640-12654 Sentence denotes FULL PROTOCOL:
T101 12655-12763 Sentence denotes The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1).
T101 12655-12763 Sentence denotes The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1).
T102 12764-12944 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.
T102 12764-12944 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.