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

inclusion criteria: 1. age: 45 and older (in france: 55 and older) 2. a confirmed diagnosis of covid-19 infection, within the last 28 days, prior to randomization, as determined by pcr or other approved commercial or public health assay, in a specimen as specified by the test used. 3. hospitalized, in observation or planned to be hospitalized due to covid-19 infection symptoms with anticipated hospitalization duration \>=3 days a. patients can be included even if treated with: oxygen supplementation, high-flow oxygen (hfo2), bipap and cpap 4. with evidence of pneumonia based on all of the following: 1. clinical findings on a physical examination 2. respiratory symptoms developed within the past 14 days 5. with evidence of respiratory decompensation that started not more than 7 days before start of study medication and present at screening, meeting one of the following criteria, as assessed by healthcare staff: 1. tachypnea: ≥25 breaths per minute 2. arterial oxygen saturation ≤92% 3. a special note should be made if there is suspicion of covid-19- related myocarditis or pericarditis, as the presence of these is a stratification criterion 6. without a significant deterioration in liver function tests: 1. alt and ast ≤ 5x upper limit of normal (uln) 2. gamma-glutamyl transferase (ggt) ≤ 5x uln 3. total bilirubin ≤ 5×uln 7. willing to participate and able to sign an informed consent form (icf) 8. female subjects should be: at least 5 years post-menopausal (i.e., persistent amenorrhea 5 years in the absence of an alternative medical cause) or surgically sterile; or 1. have a negative urine pregnancy test at screening 2. be willing to use a contraceptive method as outlined in inclusion criterion 9 from screening to 30 days after last dose. 9. male subjects who are sexually active with a female partner must agree to the use of an effective method of birth control throughout the study and until 3 months after the last administration of investigational product; note: medically acceptable methods of contraception that may be used by the subject and/or partner include combined oral contraceptive, contraceptive vaginal ring, contraceptive injection, intrauterine device, etonogestrel implant, each supplemented with a condom, as well as sterilization and vasectomy. 10. male subjects must agree not to donate sperm for the purpose of reproduction throughout the study and until 3 months after the last administration of investigational product; 11. for france only: being affiliated with a european social security.

inclusion criteria: 1. age: 45 and older (in france: 55 and older) 2. a confirmed diagnosis of covid-19 infection, within the last 28 days, prior to randomization, as determined by pcr or other approved commercial or public health assay, in a specimen as specified by the test used. 3. hospitalized, in observation or planned to be hospitalized due to covid-19 infection symptoms with anticipated hospitalization duration \>=3 days a. patients can be included even if treated with: oxygen supplementation, high-flow oxygen (hfo2), bipap and cpap 4. with evidence of pneumonia based on all of the following: 1. clinical findings on a physical examination 2. respiratory symptoms developed within the past 14 days 5. with evidence of respiratory decompensation that started not more than 7 days before start of study medication and present at screening, meeting one of the following criteria, as assessed by healthcare staff: 1. tachypnea: ≥25 breaths per minute 2. arterial oxygen saturation ≤92% 3. a special note should be made if there is suspicion of covid-19- related myocarditis or pericarditis, as the presence of these is a stratification criterion 6. without a significant deterioration in liver function tests: 1. alt and ast ≤ 5x upper limit of normal (uln) 2. gamma-glutamyl transferase (ggt) ≤ 5x uln 3. total bilirubin ≤ 5×uln 7. willing to participate and able to sign an informed consent form (icf) 8. female subjects should be: at least 5 years post-menopausal (i.e., persistent amenorrhea 5 years in the absence of an alternative medical cause) or surgically sterile; or 1. have a negative urine pregnancy test at screening 2. be willing to use a contraceptive method as outlined in inclusion criterion 9 from screening to 30 days after last dose. 9. male subjects who are sexually active with a female partner must agree to the use of an effective method of birth control throughout the study and until 3 months after the last administration of investigational product; note: medically acceptable methods of contraception that may be used by the subject and/or partner include combined oral contraceptive, contraceptive vaginal ring, contraceptive injection, intrauterine device, etonogestrel implant, each supplemented with a condom, as well as sterilization and vasectomy. 10. male subjects must agree not to donate sperm for the purpose of reproduction throughout the study and until 3 months after the last administration of investigational product; 11. for france only: being affiliated with a european social security.

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

inclusion criteria: age: 45 and older (in france: 55 and older) a confirmed diagnosis of covid-19 infection, within the last 28 days, prior to randomization, as determined by pcr or other approved commercial or public health assay, in a specimen as specified by the test used. hospitalized, in observation or planned to be hospitalized due to covid-19 infection symptoms with anticipated hospitalization duration >=3 days a. patients can be included even if treated with: oxygen supplementation, high-flow oxygen (hfo2), bipap and cpap with evidence of pneumonia based on all of the following: clinical findings on a physical examination respiratory symptoms developed within the past 14 days with evidence of respiratory decompensation that started not more than 7 days before start of study medication and present at screening, meeting one of the following criteria, as assessed by healthcare staff: tachypnea: ≥25 breaths per minute arterial oxygen saturation ≤92% a special note should be made if there is suspicion of covid-19- related myocarditis or pericarditis, as the presence of these is a stratification criterion without a significant deterioration in liver function tests: alt and ast ≤ 5x upper limit of normal (uln) gamma-glutamyl transferase (ggt) ≤ 5x uln total bilirubin ≤ 5×uln willing to participate and able to sign an informed consent form (icf) female subjects should be: at least 5 years post-menopausal (i.e., persistent amenorrhea 5 years in the absence of an alternative medical cause) or surgically sterile; or have a negative urine pregnancy test at screening be willing to use a contraceptive method as outlined in inclusion criterion 9 from screening to 30 days after last dose. male subjects who are sexually active with a female partner must agree to the use of an effective method of birth control throughout the study and until 3 months after the last administration of investigational product; note: medically acceptable methods of contraception that may be used by the subject and/or partner include combined oral contraceptive, contraceptive vaginal ring, contraceptive injection, intrauterine device, etonogestrel implant, each supplemented with a condom, as well as sterilization and vasectomy. male subjects must agree not to donate sperm for the purpose of reproduction throughout the study and until 3 months after the last administration of investigational product; for france only: being affiliated with a european social security.

inclusion criteria: age: 45 and older (in france: 55 and older) a confirmed diagnosis of covid-19 infection, within the last 28 days, prior to randomization, as determined by pcr or other approved commercial or public health assay, in a specimen as specified by the test used. hospitalized, in observation or planned to be hospitalized due to covid-19 infection symptoms with anticipated hospitalization duration >=3 days a. patients can be included even if treated with: oxygen supplementation, high-flow oxygen (hfo2), bipap and cpap with evidence of pneumonia based on all of the following: clinical findings on a physical examination respiratory symptoms developed within the past 14 days with evidence of respiratory decompensation that started not more than 7 days before start of study medication and present at screening, meeting one of the following criteria, as assessed by healthcare staff: tachypnea: ≥25 breaths per minute arterial oxygen saturation ≤92% a special note should be made if there is suspicion of covid-19- related myocarditis or pericarditis, as the presence of these is a stratification criterion without a significant deterioration in liver function tests: alt and ast ≤ 5x upper limit of normal (uln) gamma-glutamyl transferase (ggt) ≤ 5x uln total bilirubin ≤ 5×uln willing to participate and able to sign an informed consent form (icf) female subjects should be: at least 5 years post-menopausal (i.e., persistent amenorrhea 5 years in the absence of an alternative medical cause) or surgically sterile; or have a negative urine pregnancy test at screening be willing to use a contraceptive method as outlined in inclusion criterion 9 from screening to 30 days after last dose. male subjects who are sexually active with a female partner must agree to the use of an effective method of birth control throughout the study and until 3 months after the last administration of investigational product; note: medically acceptable methods of contraception that may be used by the subject and/or partner include combined oral contraceptive, contraceptive vaginal ring, contraceptive injection, intrauterine device, etonogestrel implant, each supplemented with a condom, as well as sterilization and vasectomy. male subjects must agree not to donate sperm for the purpose of reproduction throughout the study and until 3 months after the last administration of investigational product; for france only: being affiliated with a european social security.

Feb. 25, 2021, 7:58 p.m. usa

inclusion criteria: 1. age: 45 and older (in france: 55 and older) 2. a confirmed diagnosis of covid-19 infection, within the last 28 days, prior to randomization, as determined by pcr or other approved commercial or public health assay, in a specimen as specified by the test used. 3. hospitalized, in observation or planned to be hospitalized due to covid-19 infection symptoms with anticipated hospitalization duration >=3 days a. patients can be included even if treated with: oxygen supplementation, high-flow oxygen (hfo2), bipap and cpap 4. with evidence of pneumonia based on all of the following: 1. clinical findings on a physical examination 2. respiratory symptoms developed within the past 14 days 5. with evidence of respiratory decompensation that started not more than 7 days before start of study medication and present at screening, meeting one of the following criteria, as assessed by healthcare staff: 1. tachypnea: ≥25 breaths per minute 2. arterial oxygen saturation ≤92% 3. a special note should be made if there is suspicion of covid-19- related myocarditis or pericarditis, as the presence of these is a stratification criterion 6. without a significant deterioration in liver function tests: 1. alt and ast ≤ 5x upper limit of normal (uln) 2. gamma-glutamyl transferase (ggt) ≤ 5x uln 3. total bilirubin ≤ 5×uln 7. willing to participate and able to sign an informed consent form (icf) 8. female subjects should be: at least 5 years post-menopausal (i.e., persistent amenorrhea 5 years in the absence of an alternative medical cause) or surgically sterile; or 1. have a negative urine pregnancy test at screening 2. be willing to use a contraceptive method as outlined in inclusion criterion 9 from screening to 30 days after last dose. 9. male subjects who are sexually active with a female partner must agree to the use of an effective method of birth control throughout the study and until 3 months after the last administration of investigational product; note: medically acceptable methods of contraception that may be used by the subject and/or partner include combined oral contraceptive, contraceptive vaginal ring, contraceptive injection, intrauterine device, etonogestrel implant, each supplemented with a condom, as well as sterilization and vasectomy. 10. male subjects must agree not to donate sperm for the purpose of reproduction throughout the study and until 3 months after the last administration of investigational product; 11. for france only: being affiliated with a european social security.

inclusion criteria: 1. age: 45 and older (in france: 55 and older) 2. a confirmed diagnosis of covid-19 infection, within the last 28 days, prior to randomization, as determined by pcr or other approved commercial or public health assay, in a specimen as specified by the test used. 3. hospitalized, in observation or planned to be hospitalized due to covid-19 infection symptoms with anticipated hospitalization duration >=3 days a. patients can be included even if treated with: oxygen supplementation, high-flow oxygen (hfo2), bipap and cpap 4. with evidence of pneumonia based on all of the following: 1. clinical findings on a physical examination 2. respiratory symptoms developed within the past 14 days 5. with evidence of respiratory decompensation that started not more than 7 days before start of study medication and present at screening, meeting one of the following criteria, as assessed by healthcare staff: 1. tachypnea: ≥25 breaths per minute 2. arterial oxygen saturation ≤92% 3. a special note should be made if there is suspicion of covid-19- related myocarditis or pericarditis, as the presence of these is a stratification criterion 6. without a significant deterioration in liver function tests: 1. alt and ast ≤ 5x upper limit of normal (uln) 2. gamma-glutamyl transferase (ggt) ≤ 5x uln 3. total bilirubin ≤ 5×uln 7. willing to participate and able to sign an informed consent form (icf) 8. female subjects should be: at least 5 years post-menopausal (i.e., persistent amenorrhea 5 years in the absence of an alternative medical cause) or surgically sterile; or 1. have a negative urine pregnancy test at screening 2. be willing to use a contraceptive method as outlined in inclusion criterion 9 from screening to 30 days after last dose. 9. male subjects who are sexually active with a female partner must agree to the use of an effective method of birth control throughout the study and until 3 months after the last administration of investigational product; note: medically acceptable methods of contraception that may be used by the subject and/or partner include combined oral contraceptive, contraceptive vaginal ring, contraceptive injection, intrauterine device, etonogestrel implant, each supplemented with a condom, as well as sterilization and vasectomy. 10. male subjects must agree not to donate sperm for the purpose of reproduction throughout the study and until 3 months after the last administration of investigational product; 11. for france only: being affiliated with a european social security.

Jan. 29, 2021, 12:31 a.m. usa

inclusion criteria: 1. age: 45 and older (in france: 55 and older) 2. a confirmed diagnosis of covid-19 infection, within the last 28 days, prior to randomization, as determined by pcr or other approved commercial or public health assay, in a specimen as specified by the test used. 3. hospitalized, in observation or planned to be hospitalized due to covid-19 infection symptoms with anticipated hospitalization duration >=3 days 4. with evidence of pneumonia based on all of the following: 1. clinical findings on a physical examination 2. respiratory symptoms developed within the past 14 days 5. with evidence of respiratory decompensation that started not more than 7 days before start of study medication and present at screening, meeting one of the following criteria, as assessed by healthcare staff: 1. tachypnea: ≥25 breaths per minute 2. arterial oxygen saturation ≤92% 3. a special note should be made if there is suspicion of covid-19- related myocarditis or pericarditis, as the presence of these is a stratification criterion 6. without a significant deterioration in liver function tests: 1. alt and ast ≤ 5x upper limit of normal (uln) 2. gamma-glutamyl transferase (ggt) ≤ 5x uln 3. total bilirubin ≤ 5×uln 7. willing to participate and able to sign an informed consent form (icf) 8. female subjects should be: at least 5 years post-menopausal (i.e., persistent amenorrhea 5 years in the absence of an alternative medical cause) or surgically sterile; or 1. have a negative urine pregnancy test at screening 2. be willing to use a contraceptive method as outlined in inclusion criterion 9 from screening to 30 days after last dose. 9. male subjects who are sexually active with a female partner must agree to the use of an effective method of birth control throughout the study and until 3 months after the last administration of investigational product; note: medically acceptable methods of contraception that may be used by the subject and/or partner include combined oral contraceptive, contraceptive vaginal ring, contraceptive injection, intrauterine device, etonogestrel implant, each supplemented with a condom, as well as sterilization and vasectomy. 10. male subjects must agree not to donate sperm for the purpose of reproduction throughout the study and until 3 months after the last administration of investigational product; 11. for france only: being affiliated with a european social security.

inclusion criteria: 1. age: 45 and older (in france: 55 and older) 2. a confirmed diagnosis of covid-19 infection, within the last 28 days, prior to randomization, as determined by pcr or other approved commercial or public health assay, in a specimen as specified by the test used. 3. hospitalized, in observation or planned to be hospitalized due to covid-19 infection symptoms with anticipated hospitalization duration >=3 days 4. with evidence of pneumonia based on all of the following: 1. clinical findings on a physical examination 2. respiratory symptoms developed within the past 14 days 5. with evidence of respiratory decompensation that started not more than 7 days before start of study medication and present at screening, meeting one of the following criteria, as assessed by healthcare staff: 1. tachypnea: ≥25 breaths per minute 2. arterial oxygen saturation ≤92% 3. a special note should be made if there is suspicion of covid-19- related myocarditis or pericarditis, as the presence of these is a stratification criterion 6. without a significant deterioration in liver function tests: 1. alt and ast ≤ 5x upper limit of normal (uln) 2. gamma-glutamyl transferase (ggt) ≤ 5x uln 3. total bilirubin ≤ 5×uln 7. willing to participate and able to sign an informed consent form (icf) 8. female subjects should be: at least 5 years post-menopausal (i.e., persistent amenorrhea 5 years in the absence of an alternative medical cause) or surgically sterile; or 1. have a negative urine pregnancy test at screening 2. be willing to use a contraceptive method as outlined in inclusion criterion 9 from screening to 30 days after last dose. 9. male subjects who are sexually active with a female partner must agree to the use of an effective method of birth control throughout the study and until 3 months after the last administration of investigational product; note: medically acceptable methods of contraception that may be used by the subject and/or partner include combined oral contraceptive, contraceptive vaginal ring, contraceptive injection, intrauterine device, etonogestrel implant, each supplemented with a condom, as well as sterilization and vasectomy. 10. male subjects must agree not to donate sperm for the purpose of reproduction throughout the study and until 3 months after the last administration of investigational product; 11. for france only: being affiliated with a european social security.

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

inclusion criteria: 1. age: 55 and older. 2. a confirmed diagnosis of covid-19 infection, within the last 14 days, prior to randomization, as determined by pcr or other approved commercial or public health assay, in a specimen as specified by the test used. 3. hospitalized, in observation or planned to be hospitalized due to covid-19 infection symptoms with anticipated hospitalization duration >=3 days 4. with evidence of pneumonia based on all of the following: 1. clinical findings on a physical examination 2. respiratory symptoms developed within the past 7 days 5. with evidence of respiratory decompensation that started not more than 4 days before start of study medication and present at screening, meeting one of the following criteria, as assessed by healthcare staff: 1. tachypnea: ≥25 breaths per minute 2. arterial oxygen saturation ≤92%, on oxygen at at least 3l/min 3. a special note should be made if there is suspicion of covid-19- related myocarditis or pericarditis, as the presence of these is a stratification criterion 6. without a significant deterioration in liver function tests: 1. alt and ast ≤ 5x upper limit of normal (uln) 2. gamma-glutamyl transferase (ggt) ≤ 5x uln 3. total bilirubin ≤ 5×uln 7. willing to participate and able to sign an informed consent form (icf) 8. female subjects should be: at least 5 years post-menopausal (i.e., persistent amenorrhea 5 years in the absence of an alternative medical cause) or surgically sterile; or 1. have a negative urine pregnancy test at screening 2. be willing to use a contraceptive method as outlined in inclusion criterion 9 from screening to 30 days after last dose. 9. male subjects who are sexually active with a female partner must agree to the use of an effective method of birth control throughout the study and until 3 months after the last administration of investigational product; note: medically acceptable methods of contraception that may be used by the subject and/or partner include combined oral contraceptive, contraceptive vaginal ring, contraceptive injection, intrauterine device,etonogestrel implant, each supplemented with a condom, as well as sterilization and vasectomy. 10. male subjects must agree not to donate sperm for the purpose of reproduction throughout the study and until 3 months after the last administration of investigational product; 11. for france only: being affiliated with a european social security.

inclusion criteria: 1. age: 55 and older. 2. a confirmed diagnosis of covid-19 infection, within the last 14 days, prior to randomization, as determined by pcr or other approved commercial or public health assay, in a specimen as specified by the test used. 3. hospitalized, in observation or planned to be hospitalized due to covid-19 infection symptoms with anticipated hospitalization duration >=3 days 4. with evidence of pneumonia based on all of the following: 1. clinical findings on a physical examination 2. respiratory symptoms developed within the past 7 days 5. with evidence of respiratory decompensation that started not more than 4 days before start of study medication and present at screening, meeting one of the following criteria, as assessed by healthcare staff: 1. tachypnea: ≥25 breaths per minute 2. arterial oxygen saturation ≤92%, on oxygen at at least 3l/min 3. a special note should be made if there is suspicion of covid-19- related myocarditis or pericarditis, as the presence of these is a stratification criterion 6. without a significant deterioration in liver function tests: 1. alt and ast ≤ 5x upper limit of normal (uln) 2. gamma-glutamyl transferase (ggt) ≤ 5x uln 3. total bilirubin ≤ 5×uln 7. willing to participate and able to sign an informed consent form (icf) 8. female subjects should be: at least 5 years post-menopausal (i.e., persistent amenorrhea 5 years in the absence of an alternative medical cause) or surgically sterile; or 1. have a negative urine pregnancy test at screening 2. be willing to use a contraceptive method as outlined in inclusion criterion 9 from screening to 30 days after last dose. 9. male subjects who are sexually active with a female partner must agree to the use of an effective method of birth control throughout the study and until 3 months after the last administration of investigational product; note: medically acceptable methods of contraception that may be used by the subject and/or partner include combined oral contraceptive, contraceptive vaginal ring, contraceptive injection, intrauterine device,etonogestrel implant, each supplemented with a condom, as well as sterilization and vasectomy. 10. male subjects must agree not to donate sperm for the purpose of reproduction throughout the study and until 3 months after the last administration of investigational product; 11. for france only: being affiliated with a european social security.