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

inclusion criteria: 1. male and female patients aged ≥18 years at screening 2. signed informed consent form (icf) by patient capable of giving consent, or, when the patient is not capable of giving consent, by his or her legal/authorized representative (if allowed according to local requirements) 3. clinically diagnosed with the sars-cov-2 virus by polymerase chain reaction (pcr) or by other approved diagnostic methodology within 7 days prior to randomization 4. hospitalized with covid-19-induced pneumonia evidenced by chest x-ray, computed tomography scan (ct scan) or magnetic resonance scan (mr scan) (taken within 5 days prior to randomization) 5. impaired respiratory function, defined as peripheral oxygen saturation (spo2) ≤93% on room air or partial pressure of oxygen (pao2) / fraction of inspired oxygen (fio2) \<300 millimeter of mercury (mmhg) at time of screening for cities located at altitudes greater than 2500 m above sea level, these will be substituted with spo2 \<90% and pao2/fio2 \<250 mmhg 6. acute physiologic assessment and chronic health evaluation (apache) ii score of ≥10 at time of screening 7. crp ≥20 mg/l or ferritin level ≥600 μg/l at screening 8. body weight between 45 kg and 145 kg, inclusive, at screening 9. ability to comply with the study protocol, in the investigator's judgment

inclusion criteria: 1. male and female patients aged ≥18 years at screening 2. signed informed consent form (icf) by patient capable of giving consent, or, when the patient is not capable of giving consent, by his or her legal/authorized representative (if allowed according to local requirements) 3. clinically diagnosed with the sars-cov-2 virus by polymerase chain reaction (pcr) or by other approved diagnostic methodology within 7 days prior to randomization 4. hospitalized with covid-19-induced pneumonia evidenced by chest x-ray, computed tomography scan (ct scan) or magnetic resonance scan (mr scan) (taken within 5 days prior to randomization) 5. impaired respiratory function, defined as peripheral oxygen saturation (spo2) ≤93% on room air or partial pressure of oxygen (pao2) / fraction of inspired oxygen (fio2) \<300 millimeter of mercury (mmhg) at time of screening for cities located at altitudes greater than 2500 m above sea level, these will be substituted with spo2 \<90% and pao2/fio2 \<250 mmhg 6. acute physiologic assessment and chronic health evaluation (apache) ii score of ≥10 at time of screening 7. crp ≥20 mg/l or ferritin level ≥600 μg/l at screening 8. body weight between 45 kg and 145 kg, inclusive, at screening 9. ability to comply with the study protocol, in the investigator's judgment

April 21, 2022, 1 a.m. usa

inclusion criteria: male and female patients aged ≥18 years at screening signed informed consent form (icf) by patient capable of giving consent, or, when the patient is not capable of giving consent, by his or her legal/authorized representative (if allowed according to local requirements) clinically diagnosed with the sars-cov-2 virus by polymerase chain reaction (pcr) or by other approved diagnostic methodology within 7 days prior to randomization hospitalized with covid-19-induced pneumonia evidenced by chest x-ray, computed tomography scan (ct scan) or magnetic resonance scan (mr scan) (taken within 5 days prior to randomization) impaired respiratory function, defined as peripheral oxygen saturation (spo2) ≤93% on room air or partial pressure of oxygen (pao2) / fraction of inspired oxygen (fio2) <300 millimeter of mercury (mmhg) at time of screening for cities located at altitudes greater than 2500 m above sea level, these will be substituted with spo2 <90% and pao2/fio2 <250 mmhg acute physiologic assessment and chronic health evaluation (apache) ii score of ≥10 at time of screening crp ≥20 mg/l or ferritin level ≥600 μg/l at screening body weight between 45 kg and 145 kg, inclusive, at screening ability to comply with the study protocol, in the investigator's judgment

inclusion criteria: male and female patients aged ≥18 years at screening signed informed consent form (icf) by patient capable of giving consent, or, when the patient is not capable of giving consent, by his or her legal/authorized representative (if allowed according to local requirements) clinically diagnosed with the sars-cov-2 virus by polymerase chain reaction (pcr) or by other approved diagnostic methodology within 7 days prior to randomization hospitalized with covid-19-induced pneumonia evidenced by chest x-ray, computed tomography scan (ct scan) or magnetic resonance scan (mr scan) (taken within 5 days prior to randomization) impaired respiratory function, defined as peripheral oxygen saturation (spo2) ≤93% on room air or partial pressure of oxygen (pao2) / fraction of inspired oxygen (fio2) <300 millimeter of mercury (mmhg) at time of screening for cities located at altitudes greater than 2500 m above sea level, these will be substituted with spo2 <90% and pao2/fio2 <250 mmhg acute physiologic assessment and chronic health evaluation (apache) ii score of ≥10 at time of screening crp ≥20 mg/l or ferritin level ≥600 μg/l at screening body weight between 45 kg and 145 kg, inclusive, at screening ability to comply with the study protocol, in the investigator's judgment

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

inclusion criteria: participants eligible for inclusion in this study must meet all of the following criteria: male and female patients aged ≥18 years at screening signed informed consent form (icf) by patient capable of giving consent, or, when the patient is not capable of giving consent, by his or her legal/authorized representative (if allowed according to local requirements) clinically diagnosed with the sars-cov-2 virus by polymerase chain reaction (pcr) or by other approved diagnostic methodology within 7 days prior to randomization hospitalized with covid-19-induced pneumonia evidenced by chest x-ray, computed tomography scan (ct scan) or magnetic resonance scan (mr scan) (taken within 5 days prior to randomization) impaired respiratory function, defined as peripheral oxygen saturation (spo2) ≤93% on room air or partial pressure of oxygen (pao2) / fraction of inspired oxygen (fio2) <300 millimeter of mercury (mmhg) at time of screening for cities located at altitudes greater than 2500 m above sea level, these will be substituted with spo2 <90% and pao2/fio2 <250 mmhg acute physiologic assessment and chronic health evaluation (apache) ii score of ≥10 at time of screening crp ≥20 mg/l or ferritin level ≥600 μg/l at screening body weight between 45 kg and 145 kg, inclusive, at screening ability to comply with the study protocol, in the investigator's judgment

inclusion criteria: participants eligible for inclusion in this study must meet all of the following criteria: male and female patients aged ≥18 years at screening signed informed consent form (icf) by patient capable of giving consent, or, when the patient is not capable of giving consent, by his or her legal/authorized representative (if allowed according to local requirements) clinically diagnosed with the sars-cov-2 virus by polymerase chain reaction (pcr) or by other approved diagnostic methodology within 7 days prior to randomization hospitalized with covid-19-induced pneumonia evidenced by chest x-ray, computed tomography scan (ct scan) or magnetic resonance scan (mr scan) (taken within 5 days prior to randomization) impaired respiratory function, defined as peripheral oxygen saturation (spo2) ≤93% on room air or partial pressure of oxygen (pao2) / fraction of inspired oxygen (fio2) <300 millimeter of mercury (mmhg) at time of screening for cities located at altitudes greater than 2500 m above sea level, these will be substituted with spo2 <90% and pao2/fio2 <250 mmhg acute physiologic assessment and chronic health evaluation (apache) ii score of ≥10 at time of screening crp ≥20 mg/l or ferritin level ≥600 μg/l at screening body weight between 45 kg and 145 kg, inclusive, at screening ability to comply with the study protocol, in the investigator's judgment

Nov. 4, 2020, 11:31 p.m. usa

inclusion criteria: participants eligible for inclusion in this study must meet all of the following criteria: 1. male and female patients aged ≥18 years at screening 2. signed informed consent form (icf) by patient capable of giving consent, or, when the patient is not capable of giving consent, by his or her legal/authorized representative (if allowed according to local requirements) 3. clinically diagnosed with the sars-cov-2 virus by polymerase chain reaction (pcr) or by other approved diagnostic methodology within 7 days prior to randomization 4. hospitalized with covid-19-induced pneumonia evidenced by chest x-ray, computed tomography scan (ct scan) or magnetic resonance scan (mr scan) (taken within 5 days prior to randomization) 5. impaired respiratory function, defined as peripheral oxygen saturation (spo2) ≤93% on room air or partial pressure of oxygen (pao2) / fraction of inspired oxygen (fio2) <300 millimeter of mercury (mmhg) at time of screening for cities located at altitudes greater than 2500 m above sea level, these will be substituted with spo2 <90% and pao2/fio2 <250 mmhg 6. acute physiologic assessment and chronic health evaluation (apache) ii score of ≥10 at time of screening 7. crp ≥20 mg/l or ferritin level ≥600 μg/l at screening 8. body weight between 45 kg and 145 kg, inclusive, at screening 9. ability to comply with the study protocol, in the investigator's judgment

inclusion criteria: participants eligible for inclusion in this study must meet all of the following criteria: 1. male and female patients aged ≥18 years at screening 2. signed informed consent form (icf) by patient capable of giving consent, or, when the patient is not capable of giving consent, by his or her legal/authorized representative (if allowed according to local requirements) 3. clinically diagnosed with the sars-cov-2 virus by polymerase chain reaction (pcr) or by other approved diagnostic methodology within 7 days prior to randomization 4. hospitalized with covid-19-induced pneumonia evidenced by chest x-ray, computed tomography scan (ct scan) or magnetic resonance scan (mr scan) (taken within 5 days prior to randomization) 5. impaired respiratory function, defined as peripheral oxygen saturation (spo2) ≤93% on room air or partial pressure of oxygen (pao2) / fraction of inspired oxygen (fio2) <300 millimeter of mercury (mmhg) at time of screening for cities located at altitudes greater than 2500 m above sea level, these will be substituted with spo2 <90% and pao2/fio2 <250 mmhg 6. acute physiologic assessment and chronic health evaluation (apache) ii score of ≥10 at time of screening 7. crp ≥20 mg/l or ferritin level ≥600 μg/l at screening 8. body weight between 45 kg and 145 kg, inclusive, at screening 9. ability to comply with the study protocol, in the investigator's judgment

Oct. 26, 2020, 11:31 p.m. usa

inclusion criteria: participants eligible for inclusion in this study must meet all of the following criteria: 1. male and female patients aged 18-80 years inclusive at screening 2. signed informed consent form (icf) by patient capable of giving consent, or, when the patient is not capable of giving consent, by his or her legal/authorized representative (if allowed according to local requirements) 3. clinically diagnosed with the sars-cov-2 virus by polymerase chain reaction (pcr) or by other approved diagnostic methodology within 7 days prior to randomization 4. hospitalized with covid-19-induced pneumonia evidenced by chest x-ray, computed tomography scan (ct scan) or magnetic resonance scan (mr scan) (taken within 5 days prior to randomization) 5. impaired respiratory function, defined as peripheral oxygen saturation (spo2) ≤93% on room air or partial pressure of oxygen (pao2) / fraction of inspired oxygen (fio2) <300 millimeter of mercury (mmhg) at time of screening 6. acute physiologic assessment and chronic health evaluation (apache) ii score of ≥10 at time of screening 7. crp ≥20 mg/l and/or ferritin level ≥600 μg/l at screening 8. body weight between 45 kg and 120 kg, inclusive, at screening 9. ability to comply with the study protocol, in the investigator's judgment

inclusion criteria: participants eligible for inclusion in this study must meet all of the following criteria: 1. male and female patients aged 18-80 years inclusive at screening 2. signed informed consent form (icf) by patient capable of giving consent, or, when the patient is not capable of giving consent, by his or her legal/authorized representative (if allowed according to local requirements) 3. clinically diagnosed with the sars-cov-2 virus by polymerase chain reaction (pcr) or by other approved diagnostic methodology within 7 days prior to randomization 4. hospitalized with covid-19-induced pneumonia evidenced by chest x-ray, computed tomography scan (ct scan) or magnetic resonance scan (mr scan) (taken within 5 days prior to randomization) 5. impaired respiratory function, defined as peripheral oxygen saturation (spo2) ≤93% on room air or partial pressure of oxygen (pao2) / fraction of inspired oxygen (fio2) <300 millimeter of mercury (mmhg) at time of screening 6. acute physiologic assessment and chronic health evaluation (apache) ii score of ≥10 at time of screening 7. crp ≥20 mg/l and/or ferritin level ≥600 μg/l at screening 8. body weight between 45 kg and 120 kg, inclusive, at screening 9. ability to comply with the study protocol, in the investigator's judgment