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

inclusion criteria: 1. male and female subjects ≥ 18 years of age; 2. sars-cov-2-positive, confirmed by food and drug administration (fda)- or european medicines agency (ema)-authorized covid-19 test ≤ 7 days prior to randomization; 3. less than or equal to 7 days from first symptom onset to randomization; 4. subjects with moderate covid-19 consistent with the definition of "moderate" as set forth by the february 2021 fda guidance for industry: covid-19: developing drugs and biological products for treatment or prevention (fda, 2021) who at the screening/baseline/day 1 visit: 1. have felt feverish within the past 24 hours, 2. have an spo2 \> 93% on room air at sea level when sitting, and 3. meet at least one of the following criteria: i). respiratory rate: ≥ 20 breaths/minute, when the subject is sitting, ii). spo2: ≤ 96% on room air at sea level, when the subject is sitting, iii). shortness of breath: with exertion, not requiring oxygen, or vi). heart rate: ≥ 90 beats/minute, when the subject is sitting; 5. if all the criteria in inclusion 4c are met, subject must possess at least one of the following high-risk conditions known to have an underlying increased level of cytokine production; otherwise, at least two of these high-risk conditions must be met: 1. 70 years or more of age, 2. obesity (bmi ≥ 30 kg/m2), 3. diabetes (type 1 or 2), 4. uncontrolled hypertension, defined as diastolic \> 100 mm hg and/or systolic \> 150 mm hg without any current anti-hypertensive medications. at the time of screening if the subject is on anti- hypertensive medication(s) and diastolic or systolic rates are elevated, subject may be enrolled after consultation with the medical monitor, 5. known respiratory disease (including asthma or chronic obstructive pulmonary disease \[copd\]), 6. known heart failure (note: subjects with new york heart association class iv congestive heart failure cannot be enrolled per exclusion criterion 4), or 7. known coronary disease; 6. plasma crp level must be collected at screening/baseline/day 1 visit; 7. acceptable overall medical condition to be safely enrolled in and complete the study (with specific regard to cardiovascular, renal, and hepatic conditions) in the opinion of the investigator; 8. ability to provide written, informed consent prior to initiation of any study- related procedures, and ability in the opinion of the investigator to understand and comply with all the requirements of the study, which includes abstaining from the use of prohibited medications. 9. subject must present with at least moderate symptomatology, based on having symptoms in the prior 24 hours that were uncomfortable and interfered with daily activities or required treatment other than study drug and having at least one of the following symptoms: cough; fatigue; myalgia; diarrhea; vomiting; nausea; headache; sore throat; nasal congestion; rhinorrhea; loss of taste; loss of smell; fainting; or chills, shivering, and/or sweating.

inclusion criteria: 1. male and female subjects ≥ 18 years of age; 2. sars-cov-2-positive, confirmed by food and drug administration (fda)- or european medicines agency (ema)-authorized covid-19 test ≤ 7 days prior to randomization; 3. less than or equal to 7 days from first symptom onset to randomization; 4. subjects with moderate covid-19 consistent with the definition of "moderate" as set forth by the february 2021 fda guidance for industry: covid-19: developing drugs and biological products for treatment or prevention (fda, 2021) who at the screening/baseline/day 1 visit: 1. have felt feverish within the past 24 hours, 2. have an spo2 \> 93% on room air at sea level when sitting, and 3. meet at least one of the following criteria: i). respiratory rate: ≥ 20 breaths/minute, when the subject is sitting, ii). spo2: ≤ 96% on room air at sea level, when the subject is sitting, iii). shortness of breath: with exertion, not requiring oxygen, or vi). heart rate: ≥ 90 beats/minute, when the subject is sitting; 5. if all the criteria in inclusion 4c are met, subject must possess at least one of the following high-risk conditions known to have an underlying increased level of cytokine production; otherwise, at least two of these high-risk conditions must be met: 1. 70 years or more of age, 2. obesity (bmi ≥ 30 kg/m2), 3. diabetes (type 1 or 2), 4. uncontrolled hypertension, defined as diastolic \> 100 mm hg and/or systolic \> 150 mm hg without any current anti-hypertensive medications. at the time of screening if the subject is on anti- hypertensive medication(s) and diastolic or systolic rates are elevated, subject may be enrolled after consultation with the medical monitor, 5. known respiratory disease (including asthma or chronic obstructive pulmonary disease \[copd\]), 6. known heart failure (note: subjects with new york heart association class iv congestive heart failure cannot be enrolled per exclusion criterion 4), or 7. known coronary disease; 6. plasma crp level must be collected at screening/baseline/day 1 visit; 7. acceptable overall medical condition to be safely enrolled in and complete the study (with specific regard to cardiovascular, renal, and hepatic conditions) in the opinion of the investigator; 8. ability to provide written, informed consent prior to initiation of any study- related procedures, and ability in the opinion of the investigator to understand and comply with all the requirements of the study, which includes abstaining from the use of prohibited medications. 9. subject must present with at least moderate symptomatology, based on having symptoms in the prior 24 hours that were uncomfortable and interfered with daily activities or required treatment other than study drug and having at least one of the following symptoms: cough; fatigue; myalgia; diarrhea; vomiting; nausea; headache; sore throat; nasal congestion; rhinorrhea; loss of taste; loss of smell; fainting; or chills, shivering, and/or sweating.

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

inclusion criteria: male and female subjects ≥ 18 years of age; sars-cov-2-positive, confirmed by food and drug administration (fda)- or european medicines agency (ema)-authorized covid-19 test ≤ 7 days prior to randomization; less than or equal to 7 days from first symptom onset to randomization; subjects with moderate covid-19 consistent with the definition of "moderate" as set forth by the february 2021 fda guidance for industry: covid-19: developing drugs and biological products for treatment or prevention (fda, 2021) who at the screening/baseline/day 1 visit: have felt feverish within the past 24 hours, have an spo2 > 93% on room air at sea level when sitting, and meet at least one of the following criteria: i). respiratory rate: ≥ 20 breaths/minute, when the subject is sitting, ii). spo2: ≤ 96% on room air at sea level, when the subject is sitting, iii). shortness of breath: with exertion, not requiring oxygen, or vi). heart rate: ≥ 90 beats/minute, when the subject is sitting; if all the criteria in inclusion 4c are met, subject must possess at least one of the following high-risk conditions known to have an underlying increased level of cytokine production; otherwise, at least two of these high-risk conditions must be met: 70 years or more of age, obesity (bmi ≥ 30 kg/m2), diabetes (type 1 or 2), uncontrolled hypertension, defined as diastolic > 100 mm hg and/or systolic > 150 mm hg without any current anti-hypertensive medications. at the time of screening if the subject is on anti- hypertensive medication(s) and diastolic or systolic rates are elevated, subject may be enrolled after consultation with the medical monitor, known respiratory disease (including asthma or chronic obstructive pulmonary disease [copd]), known heart failure (note: subjects with new york heart association class iv congestive heart failure cannot be enrolled per exclusion criterion 4), or known coronary disease; plasma crp level must be collected at screening/baseline/day 1 visit; acceptable overall medical condition to be safely enrolled in and complete the study (with specific regard to cardiovascular, renal, and hepatic conditions) in the opinion of the investigator; ability to provide written, informed consent prior to initiation of any study- related procedures, and ability in the opinion of the investigator to understand and comply with all the requirements of the study, which includes abstaining from the use of prohibited medications. subject must present with at least moderate symptomatology, based on having symptoms in the prior 24 hours that were uncomfortable and interfered with daily activities or required treatment other than study drug and having at least one of the following symptoms: cough; fatigue; myalgia; diarrhea; vomiting; nausea; headache; sore throat; nasal congestion; rhinorrhea; loss of taste; loss of smell; fainting; or chills, shivering, and/or sweating.

inclusion criteria: male and female subjects ≥ 18 years of age; sars-cov-2-positive, confirmed by food and drug administration (fda)- or european medicines agency (ema)-authorized covid-19 test ≤ 7 days prior to randomization; less than or equal to 7 days from first symptom onset to randomization; subjects with moderate covid-19 consistent with the definition of "moderate" as set forth by the february 2021 fda guidance for industry: covid-19: developing drugs and biological products for treatment or prevention (fda, 2021) who at the screening/baseline/day 1 visit: have felt feverish within the past 24 hours, have an spo2 > 93% on room air at sea level when sitting, and meet at least one of the following criteria: i). respiratory rate: ≥ 20 breaths/minute, when the subject is sitting, ii). spo2: ≤ 96% on room air at sea level, when the subject is sitting, iii). shortness of breath: with exertion, not requiring oxygen, or vi). heart rate: ≥ 90 beats/minute, when the subject is sitting; if all the criteria in inclusion 4c are met, subject must possess at least one of the following high-risk conditions known to have an underlying increased level of cytokine production; otherwise, at least two of these high-risk conditions must be met: 70 years or more of age, obesity (bmi ≥ 30 kg/m2), diabetes (type 1 or 2), uncontrolled hypertension, defined as diastolic > 100 mm hg and/or systolic > 150 mm hg without any current anti-hypertensive medications. at the time of screening if the subject is on anti- hypertensive medication(s) and diastolic or systolic rates are elevated, subject may be enrolled after consultation with the medical monitor, known respiratory disease (including asthma or chronic obstructive pulmonary disease [copd]), known heart failure (note: subjects with new york heart association class iv congestive heart failure cannot be enrolled per exclusion criterion 4), or known coronary disease; plasma crp level must be collected at screening/baseline/day 1 visit; acceptable overall medical condition to be safely enrolled in and complete the study (with specific regard to cardiovascular, renal, and hepatic conditions) in the opinion of the investigator; ability to provide written, informed consent prior to initiation of any study- related procedures, and ability in the opinion of the investigator to understand and comply with all the requirements of the study, which includes abstaining from the use of prohibited medications. subject must present with at least moderate symptomatology, based on having symptoms in the prior 24 hours that were uncomfortable and interfered with daily activities or required treatment other than study drug and having at least one of the following symptoms: cough; fatigue; myalgia; diarrhea; vomiting; nausea; headache; sore throat; nasal congestion; rhinorrhea; loss of taste; loss of smell; fainting; or chills, shivering, and/or sweating.

July 8, 2021, 4 a.m. usa

inclusion criteria: 1. male and female subjects ≥ 18 years of age; 2. sars-cov-2-positive, confirmed by food and drug administration (fda)- or european medicines agency (ema)-authorized covid-19 test ≤ 7 days prior to randomization; 3. less than or equal to 7 days from first symptom onset to randomization; 4. subjects with moderate covid-19 consistent with the definition of "moderate" as set forth by the february 2021 fda guidance for industry: covid-19: developing drugs and biological products for treatment or prevention (fda, 2021) who at the screening/baseline/day 1 visit: 1. have felt feverish within the past 24 hours, 2. have an spo2 > 93% on room air at sea level when sitting, and 3. meet at least one of the following criteria: i). respiratory rate: ≥ 20 breaths/minute, when the subject is sitting, ii). spo2: ≤ 96% on room air at sea level, when the subject is sitting, iii). shortness of breath: with exertion, not requiring oxygen, or vi). heart rate: ≥ 90 beats/minute, when the subject is sitting; 5. if all the criteria in inclusion 4c are met, subject must possess at least one of the following high-risk conditions known to have an underlying increased level of cytokine production; otherwise, at least two of these high-risk conditions must be met: 1. 70 years or more of age, 2. obesity (bmi ≥ 30 kg/m2), 3. diabetes (type 1 or 2), 4. uncontrolled hypertension, defined as diastolic > 100 mm hg and/or systolic > 150 mm hg without any current anti-hypertensive medications. at the time of screening if the subject is on anti- hypertensive medication(s) and diastolic or systolic rates are elevated, subject may be enrolled after consultation with the medical monitor, 5. known respiratory disease (including asthma or chronic obstructive pulmonary disease [copd]), 6. known heart failure (note: subjects with new york heart association class iv congestive heart failure cannot be enrolled per exclusion criterion 4), or 7. known coronary disease; 6. plasma crp level must be collected at screening/baseline/day 1 visit; 7. acceptable overall medical condition to be safely enrolled in and complete the study (with specific regard to cardiovascular, renal, and hepatic conditions) in the opinion of the investigator; 8. ability to provide written, informed consent prior to initiation of any study- related procedures, and ability in the opinion of the investigator to understand and comply with all the requirements of the study, which includes abstaining from the use of prohibited medications. 9. subject must present with at least moderate symptomatology, based on having symptoms in the prior 24 hours that were uncomfortable and interfered with daily activities or required treatment other than study drug and having at least one of the following symptoms: cough; fatigue; myalgia; diarrhea; vomiting; nausea; headache; sore throat; nasal congestion; rhinorrhea; loss of taste; loss of smell; fainting; or chills, shivering, and/or sweating.

inclusion criteria: 1. male and female subjects ≥ 18 years of age; 2. sars-cov-2-positive, confirmed by food and drug administration (fda)- or european medicines agency (ema)-authorized covid-19 test ≤ 7 days prior to randomization; 3. less than or equal to 7 days from first symptom onset to randomization; 4. subjects with moderate covid-19 consistent with the definition of "moderate" as set forth by the february 2021 fda guidance for industry: covid-19: developing drugs and biological products for treatment or prevention (fda, 2021) who at the screening/baseline/day 1 visit: 1. have felt feverish within the past 24 hours, 2. have an spo2 > 93% on room air at sea level when sitting, and 3. meet at least one of the following criteria: i). respiratory rate: ≥ 20 breaths/minute, when the subject is sitting, ii). spo2: ≤ 96% on room air at sea level, when the subject is sitting, iii). shortness of breath: with exertion, not requiring oxygen, or vi). heart rate: ≥ 90 beats/minute, when the subject is sitting; 5. if all the criteria in inclusion 4c are met, subject must possess at least one of the following high-risk conditions known to have an underlying increased level of cytokine production; otherwise, at least two of these high-risk conditions must be met: 1. 70 years or more of age, 2. obesity (bmi ≥ 30 kg/m2), 3. diabetes (type 1 or 2), 4. uncontrolled hypertension, defined as diastolic > 100 mm hg and/or systolic > 150 mm hg without any current anti-hypertensive medications. at the time of screening if the subject is on anti- hypertensive medication(s) and diastolic or systolic rates are elevated, subject may be enrolled after consultation with the medical monitor, 5. known respiratory disease (including asthma or chronic obstructive pulmonary disease [copd]), 6. known heart failure (note: subjects with new york heart association class iv congestive heart failure cannot be enrolled per exclusion criterion 4), or 7. known coronary disease; 6. plasma crp level must be collected at screening/baseline/day 1 visit; 7. acceptable overall medical condition to be safely enrolled in and complete the study (with specific regard to cardiovascular, renal, and hepatic conditions) in the opinion of the investigator; 8. ability to provide written, informed consent prior to initiation of any study- related procedures, and ability in the opinion of the investigator to understand and comply with all the requirements of the study, which includes abstaining from the use of prohibited medications. 9. subject must present with at least moderate symptomatology, based on having symptoms in the prior 24 hours that were uncomfortable and interfered with daily activities or required treatment other than study drug and having at least one of the following symptoms: cough; fatigue; myalgia; diarrhea; vomiting; nausea; headache; sore throat; nasal congestion; rhinorrhea; loss of taste; loss of smell; fainting; or chills, shivering, and/or sweating.

Feb. 18, 2021, 12:31 a.m. usa

inclusion criteria: 1. male and female subjects ≥ 18 years of age; 2. sars-cov-2-positive, confirmed by food and drug administration (fda)- or european medicines agency (ema)-authorized covid-19 test ≤ 7 days prior to randomization; 3. less than or equal to 7 days from first symptom onset to randomization; 4. subjects with moderate covid-19 who have fever (temperature ≥ 38 ̊c / 100.4 ̊f) and shortness of breath (with exertion), not requiring oxygen, and meeting the definition of "moderate" as set forth by the may 2020 fda guidance for industry: covid-19: developing drugs and biological products for treatment or prevention (fda, 2020), which includes all of the following criteria when the subject is sitting: 1. respiratory rate: ≥ 20 breaths/minute, 2. spo2: > 93% and ≤ 96% on room air at sea level, and 3. heart rate: ≥ 90 beats/minute; 5. subject must possess at least one of the following high-risk conditions known to have an underlying increased level of cytokine production: 1. 70 years or more of age, 2. obesity (bmi ≥ 30 kg/m2), 3. diabetes (type 1 or 2), 4. uncontrolled hypertension, defined as diastolic > 100 mm hg and/or systolic > 150 mm hg without any current anti-hypertensive medications. at the time of screening if the subject is on anti- hypertensive medication(s) and diastolic or systolic rates are elevated, subject may be enrolled after consultation with the medical monitor, 5. known respiratory disease (including asthma or chronic obstructive pulmonary disease [copd]), 6. known heart failure (note: subjects with new york heart association class iv congestive heart failure cannot be enrolled per exclusion criterion 4), or 7. known coronary disease; 6. plasma crp level ≤ 20 mg/l within 72 hours of screening/baseline/day 1 visit; 7. acceptable overall medical condition to be safely enrolled in and complete the study (with specific regard to cardiovascular, renal, and hepatic conditions) in the opinion of the investigator; 8. ability to provide written, informed consent prior to initiation of any study- related procedures, and ability in the opinion of the investigator to understand and comply with all the requirements of the study, which includes abstaining from the use of prohibited medications. 9. subject must present with at least moderate symptomatology, based on having symptoms in the prior 24 hours that were uncomfortable and interfered with daily activities or required treatment other than study drug and having at least one of the following symptoms: cough; fatigue; myalgia; diarrhea; vomiting; nausea; headache; sore throat; nasal congestion; rhinorrhea; loss of taste; loss of smell; fainting; or chills, shivering, and/or sweating.

inclusion criteria: 1. male and female subjects ≥ 18 years of age; 2. sars-cov-2-positive, confirmed by food and drug administration (fda)- or european medicines agency (ema)-authorized covid-19 test ≤ 7 days prior to randomization; 3. less than or equal to 7 days from first symptom onset to randomization; 4. subjects with moderate covid-19 who have fever (temperature ≥ 38 ̊c / 100.4 ̊f) and shortness of breath (with exertion), not requiring oxygen, and meeting the definition of "moderate" as set forth by the may 2020 fda guidance for industry: covid-19: developing drugs and biological products for treatment or prevention (fda, 2020), which includes all of the following criteria when the subject is sitting: 1. respiratory rate: ≥ 20 breaths/minute, 2. spo2: > 93% and ≤ 96% on room air at sea level, and 3. heart rate: ≥ 90 beats/minute; 5. subject must possess at least one of the following high-risk conditions known to have an underlying increased level of cytokine production: 1. 70 years or more of age, 2. obesity (bmi ≥ 30 kg/m2), 3. diabetes (type 1 or 2), 4. uncontrolled hypertension, defined as diastolic > 100 mm hg and/or systolic > 150 mm hg without any current anti-hypertensive medications. at the time of screening if the subject is on anti- hypertensive medication(s) and diastolic or systolic rates are elevated, subject may be enrolled after consultation with the medical monitor, 5. known respiratory disease (including asthma or chronic obstructive pulmonary disease [copd]), 6. known heart failure (note: subjects with new york heart association class iv congestive heart failure cannot be enrolled per exclusion criterion 4), or 7. known coronary disease; 6. plasma crp level ≤ 20 mg/l within 72 hours of screening/baseline/day 1 visit; 7. acceptable overall medical condition to be safely enrolled in and complete the study (with specific regard to cardiovascular, renal, and hepatic conditions) in the opinion of the investigator; 8. ability to provide written, informed consent prior to initiation of any study- related procedures, and ability in the opinion of the investigator to understand and comply with all the requirements of the study, which includes abstaining from the use of prohibited medications. 9. subject must present with at least moderate symptomatology, based on having symptoms in the prior 24 hours that were uncomfortable and interfered with daily activities or required treatment other than study drug and having at least one of the following symptoms: cough; fatigue; myalgia; diarrhea; vomiting; nausea; headache; sore throat; nasal congestion; rhinorrhea; loss of taste; loss of smell; fainting; or chills, shivering, and/or sweating.

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

inclusion criteria: 1. male and female subjects ≥ 18 years of age; 2. sars-cov-2-positive, confirmed by food and drug administration (fda)- or european medicines agency (ema)-authorized covid-19 test ≤ 5 days prior to randomization; 3. less than or equal to 120 hours from first symptom onset to randomization; 4. subjects with moderate covid-19 who have fever (temperature ≥ 38 ̊c / 100.4 ̊f) and shortness of breath (with exertion), not requiring oxygen, and meeting the definition of "moderate" as set forth by the may 2020 fda guidance for industry: covid-19: developing drugs and biological products for treatment or prevention (fda, 2020), which includes all of the following criteria: 1. respiratory rate: ≥ 20 breaths/minute, 2. spo2: > 93% on room air at sea level, and 3. heart rate: ≥ 90 beats/minute; 5. subject must possess at least one of the following high-risk conditions known to have an underlying increased level of cytokine production: 1. 70 years or more of age, 2. obesity (bmi ≥ 30 kg/m2), 3. diabetes (type 1 or 2), 4. uncontrolled hypertension, defined as diastolic > 100 mm hg and/or systolic > 150 mm hg without any current anti-hypertensive medications. at the time of screening if the patient is on anti- hypertensive medication(s) and diastolic or systolic rates are elevated, patient may be enrolled after consultation with the medical monitor, 5. known respiratory disease (including asthma or chronic obstructive pulmonary disease [copd]), 6. known heart failure (note: subjects with new york heart association class iv congestive heart failure cannot be enrolled per exclusion criterion 4), or 7. known coronary disease; 6. plasma crp level ≤ 20 mg/l at screening/baseline/day 1 visit; 7. acceptable overall medical condition to be safely enrolled in and complete the study (with specific regard to cardiovascular, renal, and hepatic conditions) in the opinion of the investigator; 8. ability to provide written, informed consent prior to initiation of any study- related procedures, and ability (in the opinion of the investigator) to understand and comply with all the requirements of the study, which includes abstaining from the use of prohibited medications.

inclusion criteria: 1. male and female subjects ≥ 18 years of age; 2. sars-cov-2-positive, confirmed by food and drug administration (fda)- or european medicines agency (ema)-authorized covid-19 test ≤ 5 days prior to randomization; 3. less than or equal to 120 hours from first symptom onset to randomization; 4. subjects with moderate covid-19 who have fever (temperature ≥ 38 ̊c / 100.4 ̊f) and shortness of breath (with exertion), not requiring oxygen, and meeting the definition of "moderate" as set forth by the may 2020 fda guidance for industry: covid-19: developing drugs and biological products for treatment or prevention (fda, 2020), which includes all of the following criteria: 1. respiratory rate: ≥ 20 breaths/minute, 2. spo2: > 93% on room air at sea level, and 3. heart rate: ≥ 90 beats/minute; 5. subject must possess at least one of the following high-risk conditions known to have an underlying increased level of cytokine production: 1. 70 years or more of age, 2. obesity (bmi ≥ 30 kg/m2), 3. diabetes (type 1 or 2), 4. uncontrolled hypertension, defined as diastolic > 100 mm hg and/or systolic > 150 mm hg without any current anti-hypertensive medications. at the time of screening if the patient is on anti- hypertensive medication(s) and diastolic or systolic rates are elevated, patient may be enrolled after consultation with the medical monitor, 5. known respiratory disease (including asthma or chronic obstructive pulmonary disease [copd]), 6. known heart failure (note: subjects with new york heart association class iv congestive heart failure cannot be enrolled per exclusion criterion 4), or 7. known coronary disease; 6. plasma crp level ≤ 20 mg/l at screening/baseline/day 1 visit; 7. acceptable overall medical condition to be safely enrolled in and complete the study (with specific regard to cardiovascular, renal, and hepatic conditions) in the opinion of the investigator; 8. ability to provide written, informed consent prior to initiation of any study- related procedures, and ability (in the opinion of the investigator) to understand and comply with all the requirements of the study, which includes abstaining from the use of prohibited medications.