Created at Source Raw Value Validated value
June 24, 2022, 1:30 p.m. usa

inclusion criteria: subjects must exhibit symptoms (including at least one lower respiratory symptom such as shortness of breath or dyspnea) of covid-19 disease at screening and/or since the start of their hospitalization (may include treated symptoms; subjects must be 18 years and older, of either gender; subjects must have at least one of the following factors/co-morbidities: controlled or uncontrolled diabetes; pre-existing cardiovascular disease, including hypertension; pre-existing respiratory disease such as copd, asthma, emphysema; active or a former smoker with a 20 pack-years of smoking history; obesity as depicted by body mass index ≥ 30; laboratory tests indicative of a higher risk of covid-19-related complications, such as troponin >1.5 upper limit of normal, d-dimer >3.0 upper limit of normal and/or crp >1.5 upper limit of normal patient aged 70 years and older who, based on the judgment of the investigator, is at a higher risk of developing complications. subjects must have a documented positive test for the sars-cov-2 virus; subjects must be under observation by, or admitted to a controlled facility or hospital to receive standard-of-care for covid-19 disease (care for covid-19 disease should be for no more than 72 hours before screening, including any prior stay in another hospital); subject's health status must be 3 or 4 on the ordinal scale, and not previously a "5 or a 6"; if female, must be either post-menopausal (one year or greater without menses), surgically sterile, or, for female subjects of child-bearing potential who are capable of conception, must be: practicing a highly effective method of birth control (acceptable methods include intrauterine device, complete abstinence, spermicide + barrier, male partner surgical sterilization, or hormonal contraception) during the study and through 30 days after the last dose of the study medication. periodical abstinence is not classified as an effective method of birth control. a pregnancy test must be negative at the screening visit; subjects must have the ability to understand and give informed consent, which can be verbal with a witness, according to local requirements; subjects deemed capable of adequate compliance including attending scheduled visits for the duration of the study; subjects must be able to swallow the study drug capsules.

inclusion criteria: subjects must exhibit symptoms (including at least one lower respiratory symptom such as shortness of breath or dyspnea) of covid-19 disease at screening and/or since the start of their hospitalization (may include treated symptoms; subjects must be 18 years and older, of either gender; subjects must have at least one of the following factors/co-morbidities: controlled or uncontrolled diabetes; pre-existing cardiovascular disease, including hypertension; pre-existing respiratory disease such as copd, asthma, emphysema; active or a former smoker with a 20 pack-years of smoking history; obesity as depicted by body mass index ≥ 30; laboratory tests indicative of a higher risk of covid-19-related complications, such as troponin >1.5 upper limit of normal, d-dimer >3.0 upper limit of normal and/or crp >1.5 upper limit of normal patient aged 70 years and older who, based on the judgment of the investigator, is at a higher risk of developing complications. subjects must have a documented positive test for the sars-cov-2 virus; subjects must be under observation by, or admitted to a controlled facility or hospital to receive standard-of-care for covid-19 disease (care for covid-19 disease should be for no more than 72 hours before screening, including any prior stay in another hospital); subject's health status must be 3 or 4 on the ordinal scale, and not previously a "5 or a 6"; if female, must be either post-menopausal (one year or greater without menses), surgically sterile, or, for female subjects of child-bearing potential who are capable of conception, must be: practicing a highly effective method of birth control (acceptable methods include intrauterine device, complete abstinence, spermicide + barrier, male partner surgical sterilization, or hormonal contraception) during the study and through 30 days after the last dose of the study medication. periodical abstinence is not classified as an effective method of birth control. a pregnancy test must be negative at the screening visit; subjects must have the ability to understand and give informed consent, which can be verbal with a witness, according to local requirements; subjects deemed capable of adequate compliance including attending scheduled visits for the duration of the study; subjects must be able to swallow the study drug capsules.

Jan. 23, 2022, 12:30 p.m. usa

inclusion criteria: subjects must exhibit symptoms of covid-19 disease at screening and/or since the start of their hospitalization (may include treated symptoms; subjects must be 18 years and older, of either gender; subjects must have at least one of the following factors/co-morbidities: controlled or uncontrolled diabetes; pre-existing cardiovascular disease, including hypertension; pre-existing respiratory disease such as copd, asthma, emphysema; active or a former smoker with a 20 pack-years of smoking history; obesity as depicted by body mass index ≥ 30; laboratory tests indicative of a higher risk of covid-19-related complications, such as troponin >1.5 upper limit of normal, d-dimer >3.0 upper limit of normal and/or crp >1.5 upper limit of normal patient aged 70 years and older who, based on the judgment of the investigator, is at a higher risk of developing complications. subjects must have a documented positive test for the sars-cov-2 virus; subjects must be under observation by, or admitted to a controlled facility or hospital (for no more than 48 hours before screening, including any prior stay in another hospital) to receive standard-of-care for covid-19 disease; subject's health status must be 3 or 4 on the ordinal scale, and not previously a "5 or a 6"; if female, must be either post-menopausal (one year or greater without menses), surgically sterile, or, for female subjects of child-bearing potential who are capable of conception, must be: practicing a highly effective method of birth control (acceptable methods include intrauterine device, complete abstinence, spermicide + barrier, male partner surgical sterilization, or hormonal contraception) during the study and through 30 days after the last dose of the study medication. periodical abstinence is not classified as an effective method of birth control. a pregnancy test must be negative at the screening visit; subjects must have the ability to understand and give informed consent, which can be verbal with a witness, according to local requirements; subjects deemed capable of adequate compliance including attending scheduled visits for the duration of the study; subjects must be able to swallow the study drug capsules.

inclusion criteria: subjects must exhibit symptoms of covid-19 disease at screening and/or since the start of their hospitalization (may include treated symptoms; subjects must be 18 years and older, of either gender; subjects must have at least one of the following factors/co-morbidities: controlled or uncontrolled diabetes; pre-existing cardiovascular disease, including hypertension; pre-existing respiratory disease such as copd, asthma, emphysema; active or a former smoker with a 20 pack-years of smoking history; obesity as depicted by body mass index ≥ 30; laboratory tests indicative of a higher risk of covid-19-related complications, such as troponin >1.5 upper limit of normal, d-dimer >3.0 upper limit of normal and/or crp >1.5 upper limit of normal patient aged 70 years and older who, based on the judgment of the investigator, is at a higher risk of developing complications. subjects must have a documented positive test for the sars-cov-2 virus; subjects must be under observation by, or admitted to a controlled facility or hospital (for no more than 48 hours before screening, including any prior stay in another hospital) to receive standard-of-care for covid-19 disease; subject's health status must be 3 or 4 on the ordinal scale, and not previously a "5 or a 6"; if female, must be either post-menopausal (one year or greater without menses), surgically sterile, or, for female subjects of child-bearing potential who are capable of conception, must be: practicing a highly effective method of birth control (acceptable methods include intrauterine device, complete abstinence, spermicide + barrier, male partner surgical sterilization, or hormonal contraception) during the study and through 30 days after the last dose of the study medication. periodical abstinence is not classified as an effective method of birth control. a pregnancy test must be negative at the screening visit; subjects must have the ability to understand and give informed consent, which can be verbal with a witness, according to local requirements; subjects deemed capable of adequate compliance including attending scheduled visits for the duration of the study; subjects must be able to swallow the study drug capsules.

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

inclusion criteria: subjects must exhibit symptoms of covid-19 disease at screening; subjects must be 18 years and older, of either gender; subjects must have at least one of the following factors/co-morbidities: controlled or uncontrolled diabetes; pre-existing cardiovascular disease, including hypertension; pre-existing respiratory disease such as copd, asthma, emphysema; active smoker with a 20 pack-years of smoking; obesity as depicted by body mass index ≥ 30; laboratory tests indicative of a higher risk of covid-19-related complications, such as troponin >1.5 upper limit of normal and/or crp >1.5 upper limit of normal patient aged 70 years and older who, based on the judgment of the investigator, is at a higher risk of developing complications. subjects must have a documented positive test for the sars-cov-2 virus or be suspected to be positive and with a test result pending; subjects must be under observation by, or admitted to a controlled facility or hospital to receive standard-of-care for covid-19 disease; subject's health status must be 3, 4 or 5 on the ordinal scale, and not previously a 6; if female, must be either post-menopausal (one year or greater without menses), surgically sterile, or, for female subjects of child-bearing potential who are capable of conception, must be: practicing a highly effective method of birth control (acceptable methods include intrauterine device, complete abstinence, spermicide + barrier, male partner surgical sterilization, or hormonal contraception) during the study and through 30 days after the last dose of the study medication. periodical abstinence is not classified as an effective method of birth control. a pregnancy test must be negative at the screening visit; subjects must have the ability to understand and give informed consent, which can be verbal with a witness, according to local requirements; subjects deemed capable of adequate compliance including attending scheduled visits for the duration of the study; subjects must be able to swallow the study drug capsules.

inclusion criteria: subjects must exhibit symptoms of covid-19 disease at screening; subjects must be 18 years and older, of either gender; subjects must have at least one of the following factors/co-morbidities: controlled or uncontrolled diabetes; pre-existing cardiovascular disease, including hypertension; pre-existing respiratory disease such as copd, asthma, emphysema; active smoker with a 20 pack-years of smoking; obesity as depicted by body mass index ≥ 30; laboratory tests indicative of a higher risk of covid-19-related complications, such as troponin >1.5 upper limit of normal and/or crp >1.5 upper limit of normal patient aged 70 years and older who, based on the judgment of the investigator, is at a higher risk of developing complications. subjects must have a documented positive test for the sars-cov-2 virus or be suspected to be positive and with a test result pending; subjects must be under observation by, or admitted to a controlled facility or hospital to receive standard-of-care for covid-19 disease; subject's health status must be 3, 4 or 5 on the ordinal scale, and not previously a 6; if female, must be either post-menopausal (one year or greater without menses), surgically sterile, or, for female subjects of child-bearing potential who are capable of conception, must be: practicing a highly effective method of birth control (acceptable methods include intrauterine device, complete abstinence, spermicide + barrier, male partner surgical sterilization, or hormonal contraception) during the study and through 30 days after the last dose of the study medication. periodical abstinence is not classified as an effective method of birth control. a pregnancy test must be negative at the screening visit; subjects must have the ability to understand and give informed consent, which can be verbal with a witness, according to local requirements; subjects deemed capable of adequate compliance including attending scheduled visits for the duration of the study; subjects must be able to swallow the study drug capsules.

Nov. 27, 2020, 12:31 a.m. usa

inclusion criteria: 1. subjects must exhibit symptoms of covid-19 disease at screening; 2. subjects must be 18 years and older, of either gender; 3. subjects must have at least one of the following factors/co-morbidities: 1. controlled or uncontrolled diabetes; 2. pre-existing cardiovascular disease, including hypertension; 3. pre-existing respiratory disease such as copd, asthma, emphysema; 4. active smoker with a 20 pack-years of smoking; 5. obesity as depicted by body mass index ≥ 30; 6. laboratory tests indicative of a higher risk of covid-19-related complications, such as troponin >1.5 upper limit of normal and/or crp >1.5 upper limit of normal 7. patient aged 70 years and older who, based on the judgment of the investigator, is at a higher risk of developing complications. 4. subjects must have a documented positive test for the sars-cov-2 virus or be suspected to be positive and with a test result pending; 5. subjects must be under observation by, or admitted to a controlled facility or hospital to receive standard-of-care for covid-19 disease; 6. subject's health status must be 3, 4 or 5 on the ordinal scale, and not previously a 6; 7. if female, must be either post-menopausal (one year or greater without menses), surgically sterile, or, for female subjects of child-bearing potential who are capable of conception, must be: practicing a highly effective method of birth control (acceptable methods include intrauterine device, complete abstinence, spermicide + barrier, male partner surgical sterilization, or hormonal contraception) during the study and through 30 days after the last dose of the study medication. periodical abstinence is not classified as an effective method of birth control. a pregnancy test must be negative at the screening visit; 8. subjects must have the ability to understand and give informed consent, which can be verbal with a witness, according to local requirements; 9. subjects deemed capable of adequate compliance including attending scheduled visits for the duration of the study; 10. subjects must be able to swallow the study drug capsules.

inclusion criteria: 1. subjects must exhibit symptoms of covid-19 disease at screening; 2. subjects must be 18 years and older, of either gender; 3. subjects must have at least one of the following factors/co-morbidities: 1. controlled or uncontrolled diabetes; 2. pre-existing cardiovascular disease, including hypertension; 3. pre-existing respiratory disease such as copd, asthma, emphysema; 4. active smoker with a 20 pack-years of smoking; 5. obesity as depicted by body mass index ≥ 30; 6. laboratory tests indicative of a higher risk of covid-19-related complications, such as troponin >1.5 upper limit of normal and/or crp >1.5 upper limit of normal 7. patient aged 70 years and older who, based on the judgment of the investigator, is at a higher risk of developing complications. 4. subjects must have a documented positive test for the sars-cov-2 virus or be suspected to be positive and with a test result pending; 5. subjects must be under observation by, or admitted to a controlled facility or hospital to receive standard-of-care for covid-19 disease; 6. subject's health status must be 3, 4 or 5 on the ordinal scale, and not previously a 6; 7. if female, must be either post-menopausal (one year or greater without menses), surgically sterile, or, for female subjects of child-bearing potential who are capable of conception, must be: practicing a highly effective method of birth control (acceptable methods include intrauterine device, complete abstinence, spermicide + barrier, male partner surgical sterilization, or hormonal contraception) during the study and through 30 days after the last dose of the study medication. periodical abstinence is not classified as an effective method of birth control. a pregnancy test must be negative at the screening visit; 8. subjects must have the ability to understand and give informed consent, which can be verbal with a witness, according to local requirements; 9. subjects deemed capable of adequate compliance including attending scheduled visits for the duration of the study; 10. subjects must be able to swallow the study drug capsules.

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

inclusion criteria: 1. subjects must exhibit symptoms of covid-19 disease at screening; 2. subjects must be 45 years and older, of either gender; 3. subjects must have at least one of the following factors/co-morbidities: 1. controlled or uncontrolled diabetes; 2. pre-existing cardiovascular disease, including hypertension; 3. pre-existing respiratory disease such as copd, asthma, emphysema; 4. active smoker with a 20 pack-years of smoking; 5. obesity as depicted by body mass index ≥ 30; 6. laboratory tests indicative of a higher risk of covid-19-related complications, such as troponin >1.5 upper limit of normal and/or crp >1.5 upper limit of normal 7. patient aged 70 years and older who, based on the judgment of the investigator, is at a higher risk of developing complications. 4. subjects must have a documented positive test for the sars-cov-2 virus or be suspected to be positive and with a test result pending; 5. subjects must be under observation by, or admitted to a controlled facility or hospital to receive standard-of-care for covid-19 disease; 6. subject's health status must be 3 or 4 on the ordinal scale; 7. if female, must be either post-menopausal (one year or greater without menses), surgically sterile, or, for female subjects of child-bearing potential who are capable of conception, must be: practicing a highly effective method of birth control (acceptable methods include intrauterine device, complete abstinence, spermicide + barrier, male partner surgical sterilization, or hormonal contraception) during the study and through 30 days after the last dose of the study medication. periodical abstinence is not classified as an effective method of birth control. a pregnancy test must be negative at the screening visit; 8. subjects must have the ability to understand and give informed consent, which can be verbal with a witness, according to local requirements; 9. subjects deemed capable of adequate compliance including attending scheduled visits for the duration of the study; 10. subjects must be able to swallow the study drug capsules.

inclusion criteria: 1. subjects must exhibit symptoms of covid-19 disease at screening; 2. subjects must be 45 years and older, of either gender; 3. subjects must have at least one of the following factors/co-morbidities: 1. controlled or uncontrolled diabetes; 2. pre-existing cardiovascular disease, including hypertension; 3. pre-existing respiratory disease such as copd, asthma, emphysema; 4. active smoker with a 20 pack-years of smoking; 5. obesity as depicted by body mass index ≥ 30; 6. laboratory tests indicative of a higher risk of covid-19-related complications, such as troponin >1.5 upper limit of normal and/or crp >1.5 upper limit of normal 7. patient aged 70 years and older who, based on the judgment of the investigator, is at a higher risk of developing complications. 4. subjects must have a documented positive test for the sars-cov-2 virus or be suspected to be positive and with a test result pending; 5. subjects must be under observation by, or admitted to a controlled facility or hospital to receive standard-of-care for covid-19 disease; 6. subject's health status must be 3 or 4 on the ordinal scale; 7. if female, must be either post-menopausal (one year or greater without menses), surgically sterile, or, for female subjects of child-bearing potential who are capable of conception, must be: practicing a highly effective method of birth control (acceptable methods include intrauterine device, complete abstinence, spermicide + barrier, male partner surgical sterilization, or hormonal contraception) during the study and through 30 days after the last dose of the study medication. periodical abstinence is not classified as an effective method of birth control. a pregnancy test must be negative at the screening visit; 8. subjects must have the ability to understand and give informed consent, which can be verbal with a witness, according to local requirements; 9. subjects deemed capable of adequate compliance including attending scheduled visits for the duration of the study; 10. subjects must be able to swallow the study drug capsules.