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

inclusion criteria: male or female adult ≥ 18 years of age at time of screening. subjects hospitalized with severe or critical illness caused by coronavirus 2019 infection as defined below: a. severe illness: - diagnosed with covid-19 by standard rt-pcr assay or equivalent testing within 5 days of screening and symptoms of severe systemic illness/infection with covid-19: - at least 1 of the following: fever, cough, sore throat, malaise, headache, muscle pain, shortness of breath at rest or with exertion, confusion, or symptoms of severe lower respiratory symptoms including dyspnea at rest or respiratory distress and clinical signs indicative of severe systemic illness/infection with covid-19, with at least 1 of the following: - rr ≥ 30, hr ≥ 125, sao2 <93% on room air or requires > 2l oxygen by nc in order maintain sao2 ≥93%, pao2/fio2 <300 and - none of the following: respiratory failure (defined by endotracheal intubation and mechanical ventilation, oxygen delivered by high-flow nasal cannula, noninvasive positive pressure ventilation, or clinical diagnosis of respiratory failure in setting of resource limitations), septic shock (defined by sbp < 90 mm hg, or diastolic bp < 60 mm hg), multiple organ dysfunction/failure b. critical illness: - diagnosed with covid-19 by standard rt-pcr assay or equivalent testing within 5 days of screening and evidence of critical illness, defined by at least 1 of the following: - respiratory failure defined based on resource utilization requiring at least 1 of the following: endotracheal intubation and mechanical ventilation, oxygen delivered by high-flow nasal cannula, noninvasive positive pressure ventilation, ecmo, or clinical diagnosis of respiratory failure (in setting of resource limitation) or - shock (defined by sbp < 90 mm hg, or diastolic bp < 60 mm hg or requiring vasopressors) or -multiple organ dysfunction/failure subject, if intubated, positive endexpiratory pressure (peep) <15 cmh2o with pao2/fio2 >150 mmhg. electrocardiogram (ecg) with no clinically significant findings as assessed by the investigator subject (or legally authorized representative) provides written informed consent prior to initiation of any study procedures. understands and agrees to comply with planned study procedures. women of childbearing potential and their partner must agree to use at least one highly effective method of contraception (e.g., hormonal contraceptives [implants, injectables, combination oral contraceptives, transdermal patches, or contraceptive rings], intrauterine devices, bilateral tubal occlusion, or sexual abstinence) for the duration of the study.

inclusion criteria: male or female adult ≥ 18 years of age at time of screening. subjects hospitalized with severe or critical illness caused by coronavirus 2019 infection as defined below: a. severe illness: - diagnosed with covid-19 by standard rt-pcr assay or equivalent testing within 5 days of screening and symptoms of severe systemic illness/infection with covid-19: - at least 1 of the following: fever, cough, sore throat, malaise, headache, muscle pain, shortness of breath at rest or with exertion, confusion, or symptoms of severe lower respiratory symptoms including dyspnea at rest or respiratory distress and clinical signs indicative of severe systemic illness/infection with covid-19, with at least 1 of the following: - rr ≥ 30, hr ≥ 125, sao2 <93% on room air or requires > 2l oxygen by nc in order maintain sao2 ≥93%, pao2/fio2 <300 and - none of the following: respiratory failure (defined by endotracheal intubation and mechanical ventilation, oxygen delivered by high-flow nasal cannula, noninvasive positive pressure ventilation, or clinical diagnosis of respiratory failure in setting of resource limitations), septic shock (defined by sbp < 90 mm hg, or diastolic bp < 60 mm hg), multiple organ dysfunction/failure b. critical illness: - diagnosed with covid-19 by standard rt-pcr assay or equivalent testing within 5 days of screening and evidence of critical illness, defined by at least 1 of the following: - respiratory failure defined based on resource utilization requiring at least 1 of the following: endotracheal intubation and mechanical ventilation, oxygen delivered by high-flow nasal cannula, noninvasive positive pressure ventilation, ecmo, or clinical diagnosis of respiratory failure (in setting of resource limitation) or - shock (defined by sbp < 90 mm hg, or diastolic bp < 60 mm hg or requiring vasopressors) or -multiple organ dysfunction/failure subject, if intubated, positive endexpiratory pressure (peep) <15 cmh2o with pao2/fio2 >150 mmhg. electrocardiogram (ecg) with no clinically significant findings as assessed by the investigator subject (or legally authorized representative) provides written informed consent prior to initiation of any study procedures. understands and agrees to comply with planned study procedures. women of childbearing potential and their partner must agree to use at least one highly effective method of contraception (e.g., hormonal contraceptives [implants, injectables, combination oral contraceptives, transdermal patches, or contraceptive rings], intrauterine devices, bilateral tubal occlusion, or sexual abstinence) for the duration of the study.

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

inclusion criteria: 1. male or female adult ≥ 18 years of age at time of screening. 2. subjects hospitalized with severe or critical illness caused by coronavirus 2019 infection as defined below: a. severe illness: - diagnosed with covid-19 by standard rt-pcr assay or equivalent testing within 5 days of screening and symptoms of severe systemic illness/infection with covid-19: - at least 1 of the following: fever, cough, sore throat, malaise, headache, muscle pain, shortness of breath at rest or with exertion, confusion, or symptoms of severe lower respiratory symptoms including dyspnea at rest or respiratory distress and clinical signs indicative of severe systemic illness/infection with covid-19, with at least 1 of the following: - rr ≥ 30, hr ≥ 125, sao2 <93% on room air or requires > 2l oxygen by nc in order maintain sao2 ≥93%, pao2/fio2 <300 and - none of the following: respiratory failure (defined by endotracheal intubation and mechanical ventilation, oxygen delivered by high-flow nasal cannula, noninvasive positive pressure ventilation, or clinical diagnosis of respiratory failure in setting of resource limitations), septic shock (defined by sbp < 90 mm hg, or diastolic bp < 60 mm hg), multiple organ dysfunction/failure b. critical illness: - diagnosed with covid-19 by standard rt-pcr assay or equivalent testing within 5 days of screening and evidence of critical illness, defined by at least 1 of the following: - respiratory failure defined based on resource utilization requiring at least 1 of the following: endotracheal intubation and mechanical ventilation, oxygen delivered by high-flow nasal cannula, noninvasive positive pressure ventilation, ecmo, or clinical diagnosis of respiratory failure (in setting of resource limitation) or - shock (defined by sbp < 90 mm hg, or diastolic bp < 60 mm hg or requiring vasopressors) or -multiple organ dysfunction/failure 3. subject, if intubated, positive endexpiratory pressure (peep) <15 cmh2o with pao2/fio2 >150 mmhg. 4. electrocardiogram (ecg) with no clinically significant findings as assessed by the investigator 5. subject (or legally authorized representative) provides written informed consent prior to initiation of any study procedures. 6. understands and agrees to comply with planned study procedures. 7. women of childbearing potential and their partner must agree to use at least one highly effective method of contraception (e.g., hormonal contraceptives [implants, injectables, combination oral contraceptives, transdermal patches, or contraceptive rings], intrauterine devices, bilateral tubal occlusion, or sexual abstinence) for the duration of the study.

inclusion criteria: 1. male or female adult ≥ 18 years of age at time of screening. 2. subjects hospitalized with severe or critical illness caused by coronavirus 2019 infection as defined below: a. severe illness: - diagnosed with covid-19 by standard rt-pcr assay or equivalent testing within 5 days of screening and symptoms of severe systemic illness/infection with covid-19: - at least 1 of the following: fever, cough, sore throat, malaise, headache, muscle pain, shortness of breath at rest or with exertion, confusion, or symptoms of severe lower respiratory symptoms including dyspnea at rest or respiratory distress and clinical signs indicative of severe systemic illness/infection with covid-19, with at least 1 of the following: - rr ≥ 30, hr ≥ 125, sao2 <93% on room air or requires > 2l oxygen by nc in order maintain sao2 ≥93%, pao2/fio2 <300 and - none of the following: respiratory failure (defined by endotracheal intubation and mechanical ventilation, oxygen delivered by high-flow nasal cannula, noninvasive positive pressure ventilation, or clinical diagnosis of respiratory failure in setting of resource limitations), septic shock (defined by sbp < 90 mm hg, or diastolic bp < 60 mm hg), multiple organ dysfunction/failure b. critical illness: - diagnosed with covid-19 by standard rt-pcr assay or equivalent testing within 5 days of screening and evidence of critical illness, defined by at least 1 of the following: - respiratory failure defined based on resource utilization requiring at least 1 of the following: endotracheal intubation and mechanical ventilation, oxygen delivered by high-flow nasal cannula, noninvasive positive pressure ventilation, ecmo, or clinical diagnosis of respiratory failure (in setting of resource limitation) or - shock (defined by sbp < 90 mm hg, or diastolic bp < 60 mm hg or requiring vasopressors) or -multiple organ dysfunction/failure 3. subject, if intubated, positive endexpiratory pressure (peep) <15 cmh2o with pao2/fio2 >150 mmhg. 4. electrocardiogram (ecg) with no clinically significant findings as assessed by the investigator 5. subject (or legally authorized representative) provides written informed consent prior to initiation of any study procedures. 6. understands and agrees to comply with planned study procedures. 7. women of childbearing potential and their partner must agree to use at least one highly effective method of contraception (e.g., hormonal contraceptives [implants, injectables, combination oral contraceptives, transdermal patches, or contraceptive rings], intrauterine devices, bilateral tubal occlusion, or sexual abstinence) for the duration of the study.