Created at Source Raw Value Validated value
Nov. 16, 2021, 6:30 p.m. usa

subjects will not be eligible for the trial if they meet any of the following criteria: known allergy/hypersensitivity to dexamethasone or excipients of the investigational medicinal product (e.g. parabens, benzyl alcohol); fulfilled criteria for ards for ≥ 14 days at enrolment; pregnancy or breastfeeding; unwillingness to comply with contraception measurements from the enrolment to at least 1 week after the last dose of dexamethasone (sexual abstinence is considered as the adequate contraception method); end-of-life decision or patient is expected to die within next 24 hours; decision not to intubate or ceilings of treatment in place; immunosuppression and/or immunosuppressive drugs in medical history: systemic immunosuppressive drugs or chemotherapy in the past 30 days; systemic corticosteroids use before hospitalization; any dose of dexamethasone during the present hospital stay for covid-19 for more than (≥) last 5 days before enrolment; systemic corticosteroids during present hospital stay for other conditions than covid-19 (e.g. septic shock); present haematological or generalized solid malignancy; any of contraindications of corticosteroids, e.g. intractable hyperglycaemia; active gastrointestinal bleeding; adrenal gland disorders; a presence of superinfection diagnosed with locally established clinical and laboratory criteria without adequate antimicrobial treatment; cardiac arrest before icu admission; participation in another interventional trial in the last 30 days.

subjects will not be eligible for the trial if they meet any of the following criteria: known allergy/hypersensitivity to dexamethasone or excipients of the investigational medicinal product (e.g. parabens, benzyl alcohol); fulfilled criteria for ards for ≥ 14 days at enrolment; pregnancy or breastfeeding; unwillingness to comply with contraception measurements from the enrolment to at least 1 week after the last dose of dexamethasone (sexual abstinence is considered as the adequate contraception method); end-of-life decision or patient is expected to die within next 24 hours; decision not to intubate or ceilings of treatment in place; immunosuppression and/or immunosuppressive drugs in medical history: systemic immunosuppressive drugs or chemotherapy in the past 30 days; systemic corticosteroids use before hospitalization; any dose of dexamethasone during the present hospital stay for covid-19 for more than (≥) last 5 days before enrolment; systemic corticosteroids during present hospital stay for other conditions than covid-19 (e.g. septic shock); present haematological or generalized solid malignancy; any of contraindications of corticosteroids, e.g. intractable hyperglycaemia; active gastrointestinal bleeding; adrenal gland disorders; a presence of superinfection diagnosed with locally established clinical and laboratory criteria without adequate antimicrobial treatment; cardiac arrest before icu admission; participation in another interventional trial in the last 30 days.

Feb. 4, 2021, 12:31 a.m. usa

subjects will not be eligible for the trial if they meet any of the following criteria: 1. known allergy/hypersensitivity to dexamethasone or excipients of the investigational medicinal product (e.g. parabens, benzyl alcohol); 2. fulfilled criteria for ards for ≥ 14 days at enrolment; 3. pregnancy or breastfeeding; 4. unwillingness to comply with contraception measurements from the enrolment to at least 1 week after the last dose of dexamethasone (sexual abstinence is considered as the adequate contraception method); 5. end-of-life decision or patient is expected to die within next 24 hours; 6. decision not to intubate or ceilings of treatment in place; 7. immunosuppression and/or immunosuppressive drugs in medical history: 1. systemic immunosuppressive drugs or chemotherapy in the past 30 days; 2. systemic corticosteroids use before hospitalization; 3. any dose of dexamethasone during the present hospital stay for covid-19 for more than (≥) last 5 days before enrolment; 4. systemic corticosteroids during present hospital stay for other conditions than covid-19 (e.g. septic shock); 8. present haematological or generalized solid malignancy; 9. any of contraindications of corticosteroids, e.g. - intractable hyperglycaemia; - active gastrointestinal bleeding; - adrenal gland disorders; - a presence of superinfection diagnosed with locally established clinical and laboratory criteria without adequate antimicrobial treatment; 10. cardiac arrest before icu admission; 11. participation in another interventional trial in the last 30 days.

subjects will not be eligible for the trial if they meet any of the following criteria: 1. known allergy/hypersensitivity to dexamethasone or excipients of the investigational medicinal product (e.g. parabens, benzyl alcohol); 2. fulfilled criteria for ards for ≥ 14 days at enrolment; 3. pregnancy or breastfeeding; 4. unwillingness to comply with contraception measurements from the enrolment to at least 1 week after the last dose of dexamethasone (sexual abstinence is considered as the adequate contraception method); 5. end-of-life decision or patient is expected to die within next 24 hours; 6. decision not to intubate or ceilings of treatment in place; 7. immunosuppression and/or immunosuppressive drugs in medical history: 1. systemic immunosuppressive drugs or chemotherapy in the past 30 days; 2. systemic corticosteroids use before hospitalization; 3. any dose of dexamethasone during the present hospital stay for covid-19 for more than (≥) last 5 days before enrolment; 4. systemic corticosteroids during present hospital stay for other conditions than covid-19 (e.g. septic shock); 8. present haematological or generalized solid malignancy; 9. any of contraindications of corticosteroids, e.g. - intractable hyperglycaemia; - active gastrointestinal bleeding; - adrenal gland disorders; - a presence of superinfection diagnosed with locally established clinical and laboratory criteria without adequate antimicrobial treatment; 10. cardiac arrest before icu admission; 11. participation in another interventional trial in the last 30 days.

Jan. 20, 2021, 12:31 a.m. usa

subjects will not be eligible for the trial if they meet any of the following criteria: 1. known allergy/hypersensitivity to dexamethasone or excipients of the investigational medicinal product (e.g. parabens, benzyl alcohol); 2. fulfilled criteria for ards for ≥ 14 days at enrolment; 3. pregnancy or breastfeeding; 4. end-of-life decision or patient is expected to die within next 24 hours; 5. decision not to intubate or ceilings of treatment in place; 6. immunosuppression and/or immunosuppressive drugs in medical history: 1. systemic immunosuppressive drugs or chemotherapy in the past 30 days; 2. systemic corticosteroids use before hospitalization; 3. any dose of dexamethasone during the present hospital stay for covid-19 for more than (≥) last 5 days before enrolment; 4. systemic corticosteroids during present hospital stay for other conditions than covid-19 (e.g. septic shock); 7. present haematological or generalized solid malignancy; 8. any of contraindications of corticosteroids, e.g. - intractable hyperglycaemia; - active gastrointestinal bleeding; - adrenal gland disorders; - a presence of superinfection diagnosed with locally established clinical and laboratory criteria without adequate antimicrobial treatment; 9. cardiac arrest before icu admission; 10. participation in another interventional trial in the last 30 days.

subjects will not be eligible for the trial if they meet any of the following criteria: 1. known allergy/hypersensitivity to dexamethasone or excipients of the investigational medicinal product (e.g. parabens, benzyl alcohol); 2. fulfilled criteria for ards for ≥ 14 days at enrolment; 3. pregnancy or breastfeeding; 4. end-of-life decision or patient is expected to die within next 24 hours; 5. decision not to intubate or ceilings of treatment in place; 6. immunosuppression and/or immunosuppressive drugs in medical history: 1. systemic immunosuppressive drugs or chemotherapy in the past 30 days; 2. systemic corticosteroids use before hospitalization; 3. any dose of dexamethasone during the present hospital stay for covid-19 for more than (≥) last 5 days before enrolment; 4. systemic corticosteroids during present hospital stay for other conditions than covid-19 (e.g. septic shock); 7. present haematological or generalized solid malignancy; 8. any of contraindications of corticosteroids, e.g. - intractable hyperglycaemia; - active gastrointestinal bleeding; - adrenal gland disorders; - a presence of superinfection diagnosed with locally established clinical and laboratory criteria without adequate antimicrobial treatment; 9. cardiac arrest before icu admission; 10. participation in another interventional trial in the last 30 days.

Dec. 13, 2020, 12:31 a.m. usa

- known dexamethasone allergy - fulfilled criteria for ards 14 days at enrolment - pregnancy or active lactation - end-of-life decision or patient is expected to die within next 24 hours - decision not to intubate or ceilings of treatment in place. - participation in another outcome-based interventional trial within the last 30 days - immunosuppression in history, e.g. immunosuppressive drugs or chemotherapy in the past 30 days - corticosteroids before hospitalisation for other conditions than covid-19 - dexamethasone of any dose during present hospital stay for covid-19 72 hours - corticosteroids during present hospital stay for other conditions than covid-19, for example septic shock - present haematological or generalised solid malignancy - withdrawal of wic (written informed consent) - any of contraindications of corticosteroids at discretion of the investigator, e.g. intractable hyperglycaemia, active gastrointestinal bleeding and adrenal disorders. cardiac arrest before icu admission

- known dexamethasone allergy - fulfilled criteria for ards 14 days at enrolment - pregnancy or active lactation - end-of-life decision or patient is expected to die within next 24 hours - decision not to intubate or ceilings of treatment in place. - participation in another outcome-based interventional trial within the last 30 days - immunosuppression in history, e.g. immunosuppressive drugs or chemotherapy in the past 30 days - corticosteroids before hospitalisation for other conditions than covid-19 - dexamethasone of any dose during present hospital stay for covid-19 72 hours - corticosteroids during present hospital stay for other conditions than covid-19, for example septic shock - present haematological or generalised solid malignancy - withdrawal of wic (written informed consent) - any of contraindications of corticosteroids at discretion of the investigator, e.g. intractable hyperglycaemia, active gastrointestinal bleeding and adrenal disorders. cardiac arrest before icu admission