Created at Source Raw Value Validated value
June 25, 2024, noon usa

candidates will be excluded from study entry if any of the following exclusion criteria exist at the time of the screening visit (prior to randomization): * co-administration of other investigational agents against covid-19 * active sars-cov-2 infection based on clinical judgment * currently pregnant or breast feeding * current use of prednisone or equivalent \> 10 mg/daily or immunosuppressive therapy or disease modifying agents * use of full dose anticoagulation therapy or high dose anti platelet drug therapy at screening (at the discretion of the investigator, anticoagulation therapy may be added if clinically indicated) * history of myocardial infarction within past 90 days * life threatening bleed * hemodynamic instability or shock * superimposed pulmonary bacterial infection * pre-existing interstitial lung disease * active hep a/b/c hepatitis as measured with pcr for viral load and/or serologies * pre-existing liver disease: including abnormal laboratory liver function: childs pugh b/c, ast/alt \> 3 times the upper limit of normal (uln). if child pugh a, can participate on nintedanib 100 mg by mouth twice daily. * subjects with a creatinine clearance \<30 ml/min or currently on hemodialysis * inability to tolerate orally administered medication (medication must be taken with meals) * patients who are in the intensive care unit (icu) or in the step-down unit on invasive or non-invasive mechanical ventilation, ecmo, or high flow nasal cannula oxygen, will not be included. * any condition that in the opinion of the investigator, constitute a risk or a contraindication for the participation of the patient into the study or that could interfere with the study objectives, conduct or evaluation. * patients with known hypersensitivity to nintedanib, peanut, soy, or to any of the excipients.

candidates will be excluded from study entry if any of the following exclusion criteria exist at the time of the screening visit (prior to randomization): * co-administration of other investigational agents against covid-19 * active sars-cov-2 infection based on clinical judgment * currently pregnant or breast feeding * current use of prednisone or equivalent \> 10 mg/daily or immunosuppressive therapy or disease modifying agents * use of full dose anticoagulation therapy or high dose anti platelet drug therapy at screening (at the discretion of the investigator, anticoagulation therapy may be added if clinically indicated) * history of myocardial infarction within past 90 days * life threatening bleed * hemodynamic instability or shock * superimposed pulmonary bacterial infection * pre-existing interstitial lung disease * active hep a/b/c hepatitis as measured with pcr for viral load and/or serologies * pre-existing liver disease: including abnormal laboratory liver function: childs pugh b/c, ast/alt \> 3 times the upper limit of normal (uln). if child pugh a, can participate on nintedanib 100 mg by mouth twice daily. * subjects with a creatinine clearance \<30 ml/min or currently on hemodialysis * inability to tolerate orally administered medication (medication must be taken with meals) * patients who are in the intensive care unit (icu) or in the step-down unit on invasive or non-invasive mechanical ventilation, ecmo, or high flow nasal cannula oxygen, will not be included. * any condition that in the opinion of the investigator, constitute a risk or a contraindication for the participation of the patient into the study or that could interfere with the study objectives, conduct or evaluation. * patients with known hypersensitivity to nintedanib, peanut, soy, or to any of the excipients.

Oct. 17, 2022, 12:34 p.m. usa

candidates will be excluded from study entry if any of the following exclusion criteria exist at the time of the screening visit (prior to randomization): co-administration of other investigational agents against covid-19 active sars-cov-2 infection based on clinical judgment currently pregnant or breast feeding current use of prednisone or equivalent > 10 mg/daily or immunosuppressive therapy or disease modifying agents use of full dose anticoagulation therapy or high dose anti platelet drug therapy at screening (at the discretion of the investigator, anticoagulation therapy may be added if clinically indicated) history of myocardial infarction within past 90 days life threatening bleed hemodynamic instability or shock superimposed pulmonary bacterial infection pre-existing interstitial lung disease active hep a/b/c hepatitis as measured with pcr for viral load and/or serologies pre-existing liver disease: including abnormal laboratory liver function: childs pugh b/c, ast/alt > 3 times the upper limit of normal (uln). if child pugh a, can participate on nintedanib 100 mg by mouth twice daily. subjects with a creatinine clearance <30 ml/min or currently on hemodialysis inability to tolerate orally administered medication (medication must be taken with meals) patients who are in the intensive care unit (icu) or in the step-down unit on invasive or non-invasive mechanical ventilation, ecmo, or high flow nasal cannula oxygen, will not be included. any condition that in the opinion of the investigator, constitute a risk or a contraindication for the participation of the patient into the study or that could interfere with the study objectives, conduct or evaluation. patients with known hypersensitivity to nintedanib, peanut, soy, or to any of the excipients.

candidates will be excluded from study entry if any of the following exclusion criteria exist at the time of the screening visit (prior to randomization): co-administration of other investigational agents against covid-19 active sars-cov-2 infection based on clinical judgment currently pregnant or breast feeding current use of prednisone or equivalent > 10 mg/daily or immunosuppressive therapy or disease modifying agents use of full dose anticoagulation therapy or high dose anti platelet drug therapy at screening (at the discretion of the investigator, anticoagulation therapy may be added if clinically indicated) history of myocardial infarction within past 90 days life threatening bleed hemodynamic instability or shock superimposed pulmonary bacterial infection pre-existing interstitial lung disease active hep a/b/c hepatitis as measured with pcr for viral load and/or serologies pre-existing liver disease: including abnormal laboratory liver function: childs pugh b/c, ast/alt > 3 times the upper limit of normal (uln). if child pugh a, can participate on nintedanib 100 mg by mouth twice daily. subjects with a creatinine clearance <30 ml/min or currently on hemodialysis inability to tolerate orally administered medication (medication must be taken with meals) patients who are in the intensive care unit (icu) or in the step-down unit on invasive or non-invasive mechanical ventilation, ecmo, or high flow nasal cannula oxygen, will not be included. any condition that in the opinion of the investigator, constitute a risk or a contraindication for the participation of the patient into the study or that could interfere with the study objectives, conduct or evaluation. patients with known hypersensitivity to nintedanib, peanut, soy, or to any of the excipients.

April 15, 2022, 11:30 p.m. usa

candidates will be excluded from study entry if any of the following exclusion criteria exist at the time of the screening visit (prior to randomization): co-administration of other investigational agents against covid-19 active sars-cov-2 infection based on clinical judgment currently pregnant or breast feeding current use of prednisone or equivalent > 10 mg/daily use of full dose anticoagulation therapy or high dose anti platelet drug therapy at screening (at the discretion of the investigator, anticoagulation therapy may be added if clinically indicated) history of myocardial infarction within past 90 days life threatening bleed hemodynamic instability or shock superimposed pulmonary bacterial infection pre-existing interstitial lung disease active hep a/b/c hepatitis as measured with pcr for viral load and/or serologies pre-existing liver disease: including abnormal laboratory liver function: childs pugh b/c, ast/alt > 3 times the upper limit of normal (uln). if child pugh a, can participate on nintedanib 100 mg by mouth twice daily. subjects with a creatinine clearance <30 ml/min or currently on hemodialysis inability to tolerate orally administered medication (medication must be taken with meals) patients who are in the intensive care unit (icu) or in the step-down unit on invasive or non-invasive mechanical ventilation, ecmo, or high flow nasal cannula oxygen, will not be included. any condition that in the opinion of the investigator, constitute a risk or a contraindication for the participation of the patient into the study or that could interfere with the study objectives, conduct or evaluation. patients with known hypersensitivity to nintedanib, peanut, soy, or to any of the excipients.

candidates will be excluded from study entry if any of the following exclusion criteria exist at the time of the screening visit (prior to randomization): co-administration of other investigational agents against covid-19 active sars-cov-2 infection based on clinical judgment currently pregnant or breast feeding current use of prednisone or equivalent > 10 mg/daily use of full dose anticoagulation therapy or high dose anti platelet drug therapy at screening (at the discretion of the investigator, anticoagulation therapy may be added if clinically indicated) history of myocardial infarction within past 90 days life threatening bleed hemodynamic instability or shock superimposed pulmonary bacterial infection pre-existing interstitial lung disease active hep a/b/c hepatitis as measured with pcr for viral load and/or serologies pre-existing liver disease: including abnormal laboratory liver function: childs pugh b/c, ast/alt > 3 times the upper limit of normal (uln). if child pugh a, can participate on nintedanib 100 mg by mouth twice daily. subjects with a creatinine clearance <30 ml/min or currently on hemodialysis inability to tolerate orally administered medication (medication must be taken with meals) patients who are in the intensive care unit (icu) or in the step-down unit on invasive or non-invasive mechanical ventilation, ecmo, or high flow nasal cannula oxygen, will not be included. any condition that in the opinion of the investigator, constitute a risk or a contraindication for the participation of the patient into the study or that could interfere with the study objectives, conduct or evaluation. patients with known hypersensitivity to nintedanib, peanut, soy, or to any of the excipients.

Oct. 27, 2021, 11 a.m. usa

candidates will be excluded from study entry if any of the following exclusion criteria exist at the time of the screening visit (prior to randomization): - co-administration of other investigational agents against covid-19 - active sars-cov-2 infection based on clinical judgment - currently pregnant or breast feeding - current use of prednisone or equivalent > 10 mg/daily - use of full dose anticoagulation therapy or high dose anti platelet drug therapy at screening (at the discretion of the investigator, anticoagulation therapy may be added if clinically indicated) - history of myocardial infarction within past 90 days - life threatening bleed - hemodynamic instability or shock - superimposed pulmonary bacterial infection - pre-existing interstitial lung disease - active hep a/b/c hepatitis as measured with pcr for viral load and/or serologies - pre-existing liver disease: including abnormal laboratory liver function: childs pugh b/c, ast/alt > 3 times the upper limit of normal (uln). if child pugh a, can participate on nintedanib 100 mg by mouth twice daily. - subjects with a creatinine clearance <30 ml/min or currently on hemodialysis - inability to tolerate orally administered medication (medication must be taken with meals) - patients who are in the intensive care unit (icu) or in the step-down unit on invasive or non-invasive mechanical ventilation, ecmo, or high flow nasal cannula oxygen, will not be included. - any condition that in the opinion of the investigator, constitute a risk or a contraindication for the participation of the patient into the study or that could interfere with the study objectives, conduct or evaluation.

candidates will be excluded from study entry if any of the following exclusion criteria exist at the time of the screening visit (prior to randomization): - co-administration of other investigational agents against covid-19 - active sars-cov-2 infection based on clinical judgment - currently pregnant or breast feeding - current use of prednisone or equivalent > 10 mg/daily - use of full dose anticoagulation therapy or high dose anti platelet drug therapy at screening (at the discretion of the investigator, anticoagulation therapy may be added if clinically indicated) - history of myocardial infarction within past 90 days - life threatening bleed - hemodynamic instability or shock - superimposed pulmonary bacterial infection - pre-existing interstitial lung disease - active hep a/b/c hepatitis as measured with pcr for viral load and/or serologies - pre-existing liver disease: including abnormal laboratory liver function: childs pugh b/c, ast/alt > 3 times the upper limit of normal (uln). if child pugh a, can participate on nintedanib 100 mg by mouth twice daily. - subjects with a creatinine clearance <30 ml/min or currently on hemodialysis - inability to tolerate orally administered medication (medication must be taken with meals) - patients who are in the intensive care unit (icu) or in the step-down unit on invasive or non-invasive mechanical ventilation, ecmo, or high flow nasal cannula oxygen, will not be included. - any condition that in the opinion of the investigator, constitute a risk or a contraindication for the participation of the patient into the study or that could interfere with the study objectives, conduct or evaluation.

Nov. 7, 2020, 11:31 p.m. usa

candidates will be excluded from study entry if any of the following exclusion criteria exist at the time of the screening visit (prior to randomization): - co-administration of other investigational agents against covid-19 - active sars-cov-2 infection based on clinical judgment - currently pregnant or breast feeding - current use of prednisone or equivalent > 10 mg/daily - use of full dose anticoagulation therapy or high dose anti platelet drug therapy at screening (at the discretion of the investigator, anticoagulation therapy may be added if clinically indicated) - history of myocardial infarction within past 90 days - life threatening bleed - hemodynamic instability or shock - superimposed pulmonary bacterial infection - pre-existing interstitial lung disease - active hep a/b/c hepatitis as measured with pcr for viral load and/or serologies - pre-existing liver disease: including abnormal laboratory liver function: childs pugh b/c, ast/alt > 3 times the upper limit of normal (uln). if child pugh a, can participate on nintedanib 100 mg by mouth twice daily. - subjects with a creatinine clearance <30 ml/min or currently on hemodialysis - inability to tolerate orally administered medication (medication must be taken with meals)

candidates will be excluded from study entry if any of the following exclusion criteria exist at the time of the screening visit (prior to randomization): - co-administration of other investigational agents against covid-19 - active sars-cov-2 infection based on clinical judgment - currently pregnant or breast feeding - current use of prednisone or equivalent > 10 mg/daily - use of full dose anticoagulation therapy or high dose anti platelet drug therapy at screening (at the discretion of the investigator, anticoagulation therapy may be added if clinically indicated) - history of myocardial infarction within past 90 days - life threatening bleed - hemodynamic instability or shock - superimposed pulmonary bacterial infection - pre-existing interstitial lung disease - active hep a/b/c hepatitis as measured with pcr for viral load and/or serologies - pre-existing liver disease: including abnormal laboratory liver function: childs pugh b/c, ast/alt > 3 times the upper limit of normal (uln). if child pugh a, can participate on nintedanib 100 mg by mouth twice daily. - subjects with a creatinine clearance <30 ml/min or currently on hemodialysis - inability to tolerate orally administered medication (medication must be taken with meals)