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

inclusion criteria: * laboratory-confirmed novel coronavirus (sars-cov-2) infection as determined by qualitative polymerase chain reaction (pcr) at least 24 weeks prior to baseline * promis fatigue sf 7a raw score of 21 or greater at screening (confirm onset of fatigue was post-infection) * able to communicate and able to provide valid, written informed consent * ages 18 to 75 inclusive * minimum weight of 45 kg * female participants shall be either of non-child-bearing potential (permanently sterilized by bilateral tubal occlusion, hysterectomy, or bilateral salpingectomy), or menopausal (more than one year since last menstrual cycle and confirmed by blood fsh levels \> 22 miu/ml) or practicing highly effective contraception (e.g., oral (but not including progestogen-only oral contraceptives), injectable, implantable or transdermal contraceptives, a non-hormonal intrauterine device \[iud\] or an intrauterine hormone releasing system \[ius\]) for at least 2 months prior to dosing and until 125 days after the last dose. in terms of sexual relations, female participants not practicing highly effective contraception as described above should abstain or only engage with male partners who are sterile or vasectomized. female participants of child-bearing potential will also be required to have a negative serum pregnancy test \[beta human chorionic gonadotropin \[ß-hcg\]) at screening and negative pregnancy urine test at baseline. female participants must agree not to donate eggs from the first dose until 125 days after the last dose * male participants, who are not sterile or vasectomized, must agree to abstain or only engage with female partners who use highly effective contraception from the first dose until 125 days after the last dose. male participants must also agree not to donate sperm from the first dose until 125 days after the last dose

inclusion criteria: * laboratory-confirmed novel coronavirus (sars-cov-2) infection as determined by qualitative polymerase chain reaction (pcr) at least 24 weeks prior to baseline * promis fatigue sf 7a raw score of 21 or greater at screening (confirm onset of fatigue was post-infection) * able to communicate and able to provide valid, written informed consent * ages 18 to 75 inclusive * minimum weight of 45 kg * female participants shall be either of non-child-bearing potential (permanently sterilized by bilateral tubal occlusion, hysterectomy, or bilateral salpingectomy), or menopausal (more than one year since last menstrual cycle and confirmed by blood fsh levels \> 22 miu/ml) or practicing highly effective contraception (e.g., oral (but not including progestogen-only oral contraceptives), injectable, implantable or transdermal contraceptives, a non-hormonal intrauterine device \[iud\] or an intrauterine hormone releasing system \[ius\]) for at least 2 months prior to dosing and until 125 days after the last dose. in terms of sexual relations, female participants not practicing highly effective contraception as described above should abstain or only engage with male partners who are sterile or vasectomized. female participants of child-bearing potential will also be required to have a negative serum pregnancy test \[beta human chorionic gonadotropin \[ß-hcg\]) at screening and negative pregnancy urine test at baseline. female participants must agree not to donate eggs from the first dose until 125 days after the last dose * male participants, who are not sterile or vasectomized, must agree to abstain or only engage with female partners who use highly effective contraception from the first dose until 125 days after the last dose. male participants must also agree not to donate sperm from the first dose until 125 days after the last dose

April 2, 2022, 4 p.m. usa

inclusion criteria: laboratory-confirmed novel coronavirus (sars-cov-2) infection as determined by qualitative polymerase chain reaction (pcr) at least 24 weeks prior to baseline promis fatigue sf 7a raw score of 21 or greater at screening (confirm onset of fatigue was post-infection) able to communicate and able to provide valid, written informed consent ages 18 to 75 inclusive minimum weight of 45 kg female participants shall be either of non-child-bearing potential (permanently sterilized by bilateral tubal occlusion, hysterectomy, or bilateral salpingectomy), or menopausal (more than one year since last menstrual cycle and confirmed by blood fsh levels > 22 miu/ml) or practicing highly effective contraception (e.g., oral (but not including progestogen-only oral contraceptives), injectable, implantable or transdermal contraceptives, a non-hormonal intrauterine device [iud] or an intrauterine hormone releasing system [ius]) for at least 2 months prior to dosing and until 125 days after the last dose. in terms of sexual relations, female participants not practicing highly effective contraception as described above should abstain or only engage with male partners who are sterile or vasectomized. female participants of child-bearing potential will also be required to have a negative serum pregnancy test [beta human chorionic gonadotropin [ß-hcg]) at screening and negative pregnancy urine test at baseline. female participants must agree not to donate eggs from the first dose until 125 days after the last dose male participants, who are not sterile or vasectomized, must agree to abstain or only engage with female partners who use highly effective contraception from the first dose until 125 days after the last dose. male participants must also agree not to donate sperm from the first dose until 125 days after the last dose

inclusion criteria: laboratory-confirmed novel coronavirus (sars-cov-2) infection as determined by qualitative polymerase chain reaction (pcr) at least 24 weeks prior to baseline promis fatigue sf 7a raw score of 21 or greater at screening (confirm onset of fatigue was post-infection) able to communicate and able to provide valid, written informed consent ages 18 to 75 inclusive minimum weight of 45 kg female participants shall be either of non-child-bearing potential (permanently sterilized by bilateral tubal occlusion, hysterectomy, or bilateral salpingectomy), or menopausal (more than one year since last menstrual cycle and confirmed by blood fsh levels > 22 miu/ml) or practicing highly effective contraception (e.g., oral (but not including progestogen-only oral contraceptives), injectable, implantable or transdermal contraceptives, a non-hormonal intrauterine device [iud] or an intrauterine hormone releasing system [ius]) for at least 2 months prior to dosing and until 125 days after the last dose. in terms of sexual relations, female participants not practicing highly effective contraception as described above should abstain or only engage with male partners who are sterile or vasectomized. female participants of child-bearing potential will also be required to have a negative serum pregnancy test [beta human chorionic gonadotropin [ß-hcg]) at screening and negative pregnancy urine test at baseline. female participants must agree not to donate eggs from the first dose until 125 days after the last dose male participants, who are not sterile or vasectomized, must agree to abstain or only engage with female partners who use highly effective contraception from the first dose until 125 days after the last dose. male participants must also agree not to donate sperm from the first dose until 125 days after the last dose

Oct. 1, 2021, 9 a.m. usa

inclusion criteria: - laboratory-confirmed novel coronavirus (sars-cov-2) infection as determined by qualitative polymerase chain reaction (pcr) at least 12 weeks prior to baseline, but less than 24 weeks prior to baseline - promis fatigue sf 7a score of 21 or greater at screening (confirm onset of fatigue was post-infection) - able to communicate and able to provide valid, written informed consent - ages 18 to 75 inclusive - minimum weight of 45 kg - female participants shall be either of non-child-bearing potential (permanently sterilized by bilateral tubal occlusion, hysterectomy, or bilateral salpingectomy), or menopausal (more than one year since last menstrual cycle and confirmed by blood fsh levels > 22 miu/ml) or practicing highly effective contraception (e.g., oral (but not including progestogen-only oral contraceptives), injectable, implantable or transdermal contraceptives, a non-hormonal intrauterine device [iud] or an intrauterine hormone releasing system [ius]) for at least 2 months prior to dosing and until 125 days after the last dose. in terms of sexual relations, female participants not practicing highly effective contraception as described above should abstain or only engage with male partners who are sterile or vasectomized. female participants of child-bearing potential will also be required to have a negative serum pregnancy test [ß-hcg] at screening and negative pregnancy urine test at baseline. female participants must agree not to donate eggs from the first dose until 125 days after the last dose - male participants, who are not sterile or vasectomized, must agree to abstain or only engage with female partners who use highly effective contraception from the first dose until 125 days after the last dose. male participants must also agree not to donate sperm from the first dose until 125 days after the last dose

inclusion criteria: - laboratory-confirmed novel coronavirus (sars-cov-2) infection as determined by qualitative polymerase chain reaction (pcr) at least 12 weeks prior to baseline, but less than 24 weeks prior to baseline - promis fatigue sf 7a score of 21 or greater at screening (confirm onset of fatigue was post-infection) - able to communicate and able to provide valid, written informed consent - ages 18 to 75 inclusive - minimum weight of 45 kg - female participants shall be either of non-child-bearing potential (permanently sterilized by bilateral tubal occlusion, hysterectomy, or bilateral salpingectomy), or menopausal (more than one year since last menstrual cycle and confirmed by blood fsh levels > 22 miu/ml) or practicing highly effective contraception (e.g., oral (but not including progestogen-only oral contraceptives), injectable, implantable or transdermal contraceptives, a non-hormonal intrauterine device [iud] or an intrauterine hormone releasing system [ius]) for at least 2 months prior to dosing and until 125 days after the last dose. in terms of sexual relations, female participants not practicing highly effective contraception as described above should abstain or only engage with male partners who are sterile or vasectomized. female participants of child-bearing potential will also be required to have a negative serum pregnancy test [ß-hcg] at screening and negative pregnancy urine test at baseline. female participants must agree not to donate eggs from the first dose until 125 days after the last dose - male participants, who are not sterile or vasectomized, must agree to abstain or only engage with female partners who use highly effective contraception from the first dose until 125 days after the last dose. male participants must also agree not to donate sperm from the first dose until 125 days after the last dose

July 1, 2021, 2:30 a.m. usa

inclusion criteria: - laboratory-confirmed novel coronavirus (sars-cov-2) infection as determined by qualitative polymerase chain reaction (pcr) at least 12 weeks prior to baseline, but less than 24 weeks prior to baseline - facit fatigue score of </=29 at screening - patient global impression questionnaire reporting moderate or severe covid-19-related symptoms within seven days of screening - able to communicate and able to provide valid, written informed consent - ages 18 to 75 inclusive - minimum weight of 45 kg - female participants shall be either of non-child-bearing potential (permanently sterilized by bilateral tubal occlusion, hysterectomy, or bilateral salpingectomy), or menopausal (more than one year since last menstrual cycle and confirmed by blood fsh levels > 22 miu/ml) or practicing highly effective contraception (e.g., oral (but not including progestogen-only oral contraceptives), injectable, implantable or transdermal contraceptives, a non-hormonal intrauterine device [iud] or an intrauterine hormone releasing system [ius]) for at least 2 months prior to dosing and until 125 days after the last dose. in terms of sexual relations, female participants not practicing highly effective contraception as described above should abstain or only engage with male partners who are sterile or vasectomized. female participants of child-bearing potential will also be required to have a negative serum pregnancy test [ß-hcg] at screening and negative pregnancy urine test at baseline. female participants must agree not to donate eggs from the first dose until 125 days after the last dose - male participants, who are not sterile or vasectomized, must agree to abstain or only engage with female partners who use highly effective contraception from the first dose until 125 days after the last dose. male participants must also agree not to donate sperm from the first dose until 125 days after the last dose

inclusion criteria: - laboratory-confirmed novel coronavirus (sars-cov-2) infection as determined by qualitative polymerase chain reaction (pcr) at least 12 weeks prior to baseline, but less than 24 weeks prior to baseline - facit fatigue score of </=29 at screening - patient global impression questionnaire reporting moderate or severe covid-19-related symptoms within seven days of screening - able to communicate and able to provide valid, written informed consent - ages 18 to 75 inclusive - minimum weight of 45 kg - female participants shall be either of non-child-bearing potential (permanently sterilized by bilateral tubal occlusion, hysterectomy, or bilateral salpingectomy), or menopausal (more than one year since last menstrual cycle and confirmed by blood fsh levels > 22 miu/ml) or practicing highly effective contraception (e.g., oral (but not including progestogen-only oral contraceptives), injectable, implantable or transdermal contraceptives, a non-hormonal intrauterine device [iud] or an intrauterine hormone releasing system [ius]) for at least 2 months prior to dosing and until 125 days after the last dose. in terms of sexual relations, female participants not practicing highly effective contraception as described above should abstain or only engage with male partners who are sterile or vasectomized. female participants of child-bearing potential will also be required to have a negative serum pregnancy test [ß-hcg] at screening and negative pregnancy urine test at baseline. female participants must agree not to donate eggs from the first dose until 125 days after the last dose - male participants, who are not sterile or vasectomized, must agree to abstain or only engage with female partners who use highly effective contraception from the first dose until 125 days after the last dose. male participants must also agree not to donate sperm from the first dose until 125 days after the last dose