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

inclusion criteria: * ability to voluntarily provide informed consent that is documented per local requirements * an understanding, ability, and willingness to fully comply with study procedures and restrictions * hospitalized subjects with a confirmed sars-cov-2 infection * laboratory (polymerase chain reaction \[pcr\]) confirmed infection with sars-cov-2 * age ≥ 50 years * covid-19 illness of any duration, and oxygen saturation measurements ≤ 94% over 5 minutes on room air (note: low flow oxygen is permitted, but room air oxygen saturation must be ≤ 94%) * not in respiratory failure as defined by at least one of the following: 1. respiratory failure defined by requiring at least one of the following: * endotracheal intubation and mechanical ventilation * oxygen delivered by high-flow nasal cannula at flow rates \> 20 l/min with fraction of delivered oxygen ≥ 0.5) * nippv * ecmo * clinical diagnosis of respiratory failure (i.e., need for one of the preceding therapies, but preceding therapies are not being administered because it is unavailable in the current setting) 2. hemodynamic compromise (defined by systolic blood pressure \< 90 mm hg, or diastolic blood pressure \< 60 mm hg) or requiring vasopressors 3. multi-organ dysfunction/failure * females subjects of childbearing potential must have a negative pregnancy test at screening or pre-treatment on day 1 * male and female subjects of childbearing potential must agree to use methods of contraception that are consistent with local regulations for those participating in clinical studies

inclusion criteria: * ability to voluntarily provide informed consent that is documented per local requirements * an understanding, ability, and willingness to fully comply with study procedures and restrictions * hospitalized subjects with a confirmed sars-cov-2 infection * laboratory (polymerase chain reaction \[pcr\]) confirmed infection with sars-cov-2 * age ≥ 50 years * covid-19 illness of any duration, and oxygen saturation measurements ≤ 94% over 5 minutes on room air (note: low flow oxygen is permitted, but room air oxygen saturation must be ≤ 94%) * not in respiratory failure as defined by at least one of the following: 1. respiratory failure defined by requiring at least one of the following: * endotracheal intubation and mechanical ventilation * oxygen delivered by high-flow nasal cannula at flow rates \> 20 l/min with fraction of delivered oxygen ≥ 0.5) * nippv * ecmo * clinical diagnosis of respiratory failure (i.e., need for one of the preceding therapies, but preceding therapies are not being administered because it is unavailable in the current setting) 2. hemodynamic compromise (defined by systolic blood pressure \< 90 mm hg, or diastolic blood pressure \< 60 mm hg) or requiring vasopressors 3. multi-organ dysfunction/failure * females subjects of childbearing potential must have a negative pregnancy test at screening or pre-treatment on day 1 * male and female subjects of childbearing potential must agree to use methods of contraception that are consistent with local regulations for those participating in clinical studies

Nov. 16, 2021, 6:30 p.m. usa

inclusion criteria: ability to voluntarily provide informed consent that is documented per local requirements an understanding, ability, and willingness to fully comply with study procedures and restrictions hospitalized subjects with a confirmed sars-cov-2 infection laboratory (polymerase chain reaction [pcr]) confirmed infection with sars-cov-2 age ≥ 50 years covid-19 illness of any duration, and oxygen saturation measurements ≤ 94% over 5 minutes on room air (note: low flow oxygen is permitted, but room air oxygen saturation must be ≤ 94%) not in respiratory failure as defined by at least one of the following: respiratory failure defined by requiring at least one of the following: endotracheal intubation and mechanical ventilation oxygen delivered by high-flow nasal cannula at flow rates > 20 l/min with fraction of delivered oxygen ≥ 0.5) nippv ecmo clinical diagnosis of respiratory failure (i.e., need for one of the preceding therapies, but preceding therapies are not being administered because it is unavailable in the current setting) hemodynamic compromise (defined by systolic blood pressure < 90 mm hg, or diastolic blood pressure < 60 mm hg) or requiring vasopressors multi-organ dysfunction/failure females subjects of childbearing potential must have a negative pregnancy test at screening or pre-treatment on day 1 male and female subjects of childbearing potential must agree to use methods of contraception that are consistent with local regulations for those participating in clinical studies

inclusion criteria: ability to voluntarily provide informed consent that is documented per local requirements an understanding, ability, and willingness to fully comply with study procedures and restrictions hospitalized subjects with a confirmed sars-cov-2 infection laboratory (polymerase chain reaction [pcr]) confirmed infection with sars-cov-2 age ≥ 50 years covid-19 illness of any duration, and oxygen saturation measurements ≤ 94% over 5 minutes on room air (note: low flow oxygen is permitted, but room air oxygen saturation must be ≤ 94%) not in respiratory failure as defined by at least one of the following: respiratory failure defined by requiring at least one of the following: endotracheal intubation and mechanical ventilation oxygen delivered by high-flow nasal cannula at flow rates > 20 l/min with fraction of delivered oxygen ≥ 0.5) nippv ecmo clinical diagnosis of respiratory failure (i.e., need for one of the preceding therapies, but preceding therapies are not being administered because it is unavailable in the current setting) hemodynamic compromise (defined by systolic blood pressure < 90 mm hg, or diastolic blood pressure < 60 mm hg) or requiring vasopressors multi-organ dysfunction/failure females subjects of childbearing potential must have a negative pregnancy test at screening or pre-treatment on day 1 male and female subjects of childbearing potential must agree to use methods of contraception that are consistent with local regulations for those participating in clinical studies

July 14, 2021, 6 a.m. usa

inclusion criteria: - ability to voluntarily provide informed consent that is documented per local requirements - an understanding, ability, and willingness to fully comply with study procedures and restrictions - hospitalized subjects with a confirmed sars-cov-2 infection - laboratory (polymerase chain reaction [pcr]) confirmed infection with sars-cov-2 - age ≥ 50 years - covid-19 illness of any duration, and oxygen saturation measurements ≤ 94% over 5 minutes on room air (note: low flow oxygen is permitted, but room air oxygen saturation must be ≤ 94%) - not in respiratory failure as defined by at least one of the following: 1. respiratory failure defined by requiring at least one of the following: - endotracheal intubation and mechanical ventilation - oxygen delivered by high-flow nasal cannula at flow rates > 20 l/min with fraction of delivered oxygen ≥ 0.5) - nippv - ecmo - clinical diagnosis of respiratory failure (i.e., need for one of the preceding therapies, but preceding therapies are not being administered because it is unavailable in the current setting) 2. hemodynamic compromise (defined by systolic blood pressure < 90 mm hg, or diastolic blood pressure < 60 mm hg) or requiring vasopressors 3. multi-organ dysfunction/failure - females subjects of childbearing potential must have a negative pregnancy test at screening or pre-treatment on day 1 - male and female subjects of childbearing potential must agree to use methods of contraception that are consistent with local regulations for those participating in clinical studies

inclusion criteria: - ability to voluntarily provide informed consent that is documented per local requirements - an understanding, ability, and willingness to fully comply with study procedures and restrictions - hospitalized subjects with a confirmed sars-cov-2 infection - laboratory (polymerase chain reaction [pcr]) confirmed infection with sars-cov-2 - age ≥ 50 years - covid-19 illness of any duration, and oxygen saturation measurements ≤ 94% over 5 minutes on room air (note: low flow oxygen is permitted, but room air oxygen saturation must be ≤ 94%) - not in respiratory failure as defined by at least one of the following: 1. respiratory failure defined by requiring at least one of the following: - endotracheal intubation and mechanical ventilation - oxygen delivered by high-flow nasal cannula at flow rates > 20 l/min with fraction of delivered oxygen ≥ 0.5) - nippv - ecmo - clinical diagnosis of respiratory failure (i.e., need for one of the preceding therapies, but preceding therapies are not being administered because it is unavailable in the current setting) 2. hemodynamic compromise (defined by systolic blood pressure < 90 mm hg, or diastolic blood pressure < 60 mm hg) or requiring vasopressors 3. multi-organ dysfunction/failure - females subjects of childbearing potential must have a negative pregnancy test at screening or pre-treatment on day 1 - male and female subjects of childbearing potential must agree to use methods of contraception that are consistent with local regulations for those participating in clinical studies

Jan. 14, 2021, 12:31 a.m. usa

inclusion criteria: - ability to voluntarily provide informed consent that is documented per local requirements - an understanding, ability, and willingness to fully comply with study procedures and restrictions - hospitalized subjects with a confirmed sars-cov-2 infection - laboratory (polymerase chain reaction [pcr]) confirmed infection with sars-cov-2 - age ≥ 60 years - covid-19 illness of any duration, and oxygen saturation measurements ≤ 94% over 5 minutes on room air (note: low flow oxygen is permitted, but room air oxygen saturation must be ≤ 94%) - not in respiratory failure as defined by at least one of the following: 1. respiratory failure defined by requiring at least one of the following: - endotracheal intubation and mechanical ventilation - oxygen delivered by high-flow nasal cannula at flow rates > 20 l/min with fraction of delivered oxygen ≥ 0.5) - nippv - ecmo - clinical diagnosis of respiratory failure (i.e., need for one of the preceding therapies, but preceding therapies are not being administered because it is unavailable in the current setting) 2. hemodynamic compromise (defined by systolic blood pressure < 90 mm hg, or diastolic blood pressure < 60 mm hg) or requiring vasopressors 3. multi-organ dysfunction/failure - females subjects of childbearing potential must have a negative pregnancy test at screening or pre-treatment on day 1 - male and female subjects of childbearing potential must agree to use methods of contraception that are consistent with local regulations for those participating in clinical studies

inclusion criteria: - ability to voluntarily provide informed consent that is documented per local requirements - an understanding, ability, and willingness to fully comply with study procedures and restrictions - hospitalized subjects with a confirmed sars-cov-2 infection - laboratory (polymerase chain reaction [pcr]) confirmed infection with sars-cov-2 - age ≥ 60 years - covid-19 illness of any duration, and oxygen saturation measurements ≤ 94% over 5 minutes on room air (note: low flow oxygen is permitted, but room air oxygen saturation must be ≤ 94%) - not in respiratory failure as defined by at least one of the following: 1. respiratory failure defined by requiring at least one of the following: - endotracheal intubation and mechanical ventilation - oxygen delivered by high-flow nasal cannula at flow rates > 20 l/min with fraction of delivered oxygen ≥ 0.5) - nippv - ecmo - clinical diagnosis of respiratory failure (i.e., need for one of the preceding therapies, but preceding therapies are not being administered because it is unavailable in the current setting) 2. hemodynamic compromise (defined by systolic blood pressure < 90 mm hg, or diastolic blood pressure < 60 mm hg) or requiring vasopressors 3. multi-organ dysfunction/failure - females subjects of childbearing potential must have a negative pregnancy test at screening or pre-treatment on day 1 - male and female subjects of childbearing potential must agree to use methods of contraception that are consistent with local regulations for those participating in clinical studies