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

inclusion criteria: * subject must be willing, understanding and able to provide written informed consent * subject must be a man or a woman with age \> 18 years at screening * subject must have an active moderate to severe covid-19 confirmed by o a positive sars-cov-2 pcr test in the last 14 days * at least one of the following features should be present * d-dimer elevation \> 1.5 uln (age adjusted cut-offs) and/or * cardiac injury reflected by an elevation in hs-ctnt \> 2.0 upper limit of normal (uln) and at least one of the following conditions: * known coronary artery disease (cad) * known diabetes mellitus * active smoking * a woman of childbearing potential must have a negative serum or urine pregnancy test before randomization occurs. before randomization, a woman must be either: * postmenopausal, defined as \>45 years of age with amenorrhea for at least 18 months, * if menstruating: * if heterosexually active, practicing a highly effective method of birth control, including hormonal prescription oral contraceptives, contraceptive injections, contraceptive patch, intrauterine device, double-barrier method \[(e.g., condoms, diaphragm, or cervical cap, with spermicidal foam, cream, or gel)\], or male partner sterilization, consistent with local regulations regarding use of birth control methods for subjects participating in clinical studies, for the duration of their participation in the study, or * surgically sterile (have had a hysterectomy or bilateral oophorectomy, tubal ligation, or otherwise be incapable of pregnancy), or * not heterosexually active

inclusion criteria: * subject must be willing, understanding and able to provide written informed consent * subject must be a man or a woman with age \> 18 years at screening * subject must have an active moderate to severe covid-19 confirmed by o a positive sars-cov-2 pcr test in the last 14 days * at least one of the following features should be present * d-dimer elevation \> 1.5 uln (age adjusted cut-offs) and/or * cardiac injury reflected by an elevation in hs-ctnt \> 2.0 upper limit of normal (uln) and at least one of the following conditions: * known coronary artery disease (cad) * known diabetes mellitus * active smoking * a woman of childbearing potential must have a negative serum or urine pregnancy test before randomization occurs. before randomization, a woman must be either: * postmenopausal, defined as \>45 years of age with amenorrhea for at least 18 months, * if menstruating: * if heterosexually active, practicing a highly effective method of birth control, including hormonal prescription oral contraceptives, contraceptive injections, contraceptive patch, intrauterine device, double-barrier method \[(e.g., condoms, diaphragm, or cervical cap, with spermicidal foam, cream, or gel)\], or male partner sterilization, consistent with local regulations regarding use of birth control methods for subjects participating in clinical studies, for the duration of their participation in the study, or * surgically sterile (have had a hysterectomy or bilateral oophorectomy, tubal ligation, or otherwise be incapable of pregnancy), or * not heterosexually active

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

inclusion criteria: - subject must be willing, understanding and able to provide written informed consent - subject must be a man or a woman with age > 18 years at screening - subject must have an active moderate to severe covid-19 confirmed by o a positive sars-cov-2 pcr test in the last 14 days - at least one of the following features should be present - d-dimer elevation > 1.5 uln (age adjusted cut-offs) and/or - cardiac injury reflected by an elevation in hs-ctnt > 2.0 upper limit of normal (uln) and at least one of the following conditions: - known coronary artery disease (cad) - known diabetes mellitus - active smoking - a woman of childbearing potential must have a negative serum or urine pregnancy test before randomization occurs. before randomization, a woman must be either: - postmenopausal, defined as >45 years of age with amenorrhea for at least 18 months, - if menstruating: - if heterosexually active, practicing a highly effective method of birth control, including hormonal prescription oral contraceptives, contraceptive injections, contraceptive patch, intrauterine device, double-barrier method [(e.g., condoms, diaphragm, or cervical cap, with spermicidal foam, cream, or gel)], or male partner sterilization, consistent with local regulations regarding use of birth control methods for subjects participating in clinical studies, for the duration of their participation in the study, or - surgically sterile (have had a hysterectomy or bilateral oophorectomy, tubal ligation, or otherwise be incapable of pregnancy), or - not heterosexually active

inclusion criteria: - subject must be willing, understanding and able to provide written informed consent - subject must be a man or a woman with age > 18 years at screening - subject must have an active moderate to severe covid-19 confirmed by o a positive sars-cov-2 pcr test in the last 14 days - at least one of the following features should be present - d-dimer elevation > 1.5 uln (age adjusted cut-offs) and/or - cardiac injury reflected by an elevation in hs-ctnt > 2.0 upper limit of normal (uln) and at least one of the following conditions: - known coronary artery disease (cad) - known diabetes mellitus - active smoking - a woman of childbearing potential must have a negative serum or urine pregnancy test before randomization occurs. before randomization, a woman must be either: - postmenopausal, defined as >45 years of age with amenorrhea for at least 18 months, - if menstruating: - if heterosexually active, practicing a highly effective method of birth control, including hormonal prescription oral contraceptives, contraceptive injections, contraceptive patch, intrauterine device, double-barrier method [(e.g., condoms, diaphragm, or cervical cap, with spermicidal foam, cream, or gel)], or male partner sterilization, consistent with local regulations regarding use of birth control methods for subjects participating in clinical studies, for the duration of their participation in the study, or - surgically sterile (have had a hysterectomy or bilateral oophorectomy, tubal ligation, or otherwise be incapable of pregnancy), or - not heterosexually active