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

inclusion criteria: * adults (≥18 years) with laboratory-confirmed sars cov 2 infection as determined by pcr or other commercial or public health assay, which is fda cleared or approved for emergency use (test results must be obtained within 72 hours of day * a score of grade 3 (hospitalized, requiring supplemental oxygen) or grade 4 (hospitalized, on non-invasive ventilation or high flow oxygen devices) on the 6-point ordinal scale. * willingness and ability to comply with study-related procedures and assessments. * ability to provide informed consent signed by study subject or legally authorized representative. * male and/or female a)male subjects: * a male subject must agree to use contraception as detailed in appendix 12.3 of this protocol during the treatment period and for at least 6 months, corresponding to time needed to eliminate study treatment for both genotoxic and teratogenic study treatments, after the last dose of study treatment. b)female subjects: * a female subject is eligible to participate if she is not pregnant (see appendix 12.3), not planning to get pregnant in the next 6 months, not breastfeeding, and at least 1 of the following conditions applies: i) not a woman of childbearing potential (wocbp) as defined in appendix 12.3. or ii) a wocbp who agrees to follow the contraceptive guidance in appendix 12.3 during the treatment period and for at least 130 days, (5 terminal half lives and, for genotoxic products, an additional 30 days, corresponding to time needed to eliminate study treatment plus 30 days for study treatments with genotoxic potential) after the last dose of study treatment.

inclusion criteria: * adults (≥18 years) with laboratory-confirmed sars cov 2 infection as determined by pcr or other commercial or public health assay, which is fda cleared or approved for emergency use (test results must be obtained within 72 hours of day * a score of grade 3 (hospitalized, requiring supplemental oxygen) or grade 4 (hospitalized, on non-invasive ventilation or high flow oxygen devices) on the 6-point ordinal scale. * willingness and ability to comply with study-related procedures and assessments. * ability to provide informed consent signed by study subject or legally authorized representative. * male and/or female a)male subjects: * a male subject must agree to use contraception as detailed in appendix 12.3 of this protocol during the treatment period and for at least 6 months, corresponding to time needed to eliminate study treatment for both genotoxic and teratogenic study treatments, after the last dose of study treatment. b)female subjects: * a female subject is eligible to participate if she is not pregnant (see appendix 12.3), not planning to get pregnant in the next 6 months, not breastfeeding, and at least 1 of the following conditions applies: i) not a woman of childbearing potential (wocbp) as defined in appendix 12.3. or ii) a wocbp who agrees to follow the contraceptive guidance in appendix 12.3 during the treatment period and for at least 130 days, (5 terminal half lives and, for genotoxic products, an additional 30 days, corresponding to time needed to eliminate study treatment plus 30 days for study treatments with genotoxic potential) after the last dose of study treatment.

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

inclusion criteria: - adults (≥18 years) with laboratory-confirmed sars cov 2 infection as determined by pcr or other commercial or public health assay, which is fda cleared or approved for emergency use (test results must be obtained within 72 hours of day - a score of grade 3 (hospitalized, requiring supplemental oxygen) or grade 4 (hospitalized, on non-invasive ventilation or high flow oxygen devices) on the 6-point ordinal scale. - willingness and ability to comply with study-related procedures and assessments. - ability to provide informed consent signed by study subject or legally authorized representative. - male and/or female a)male subjects: - a male subject must agree to use contraception as detailed in appendix 12.3 of this protocol during the treatment period and for at least 6 months, corresponding to time needed to eliminate study treatment for both genotoxic and teratogenic study treatments, after the last dose of study treatment. b)female subjects: - a female subject is eligible to participate if she is not pregnant (see appendix 12.3), not planning to get pregnant in the next 6 months, not breastfeeding, and at least 1 of the following conditions applies: i) not a woman of childbearing potential (wocbp) as defined in appendix 12.3. or ii) a wocbp who agrees to follow the contraceptive guidance in appendix 12.3 during the treatment period and for at least 130 days, (5 terminal half lives and, for genotoxic products, an additional 30 days, corresponding to time needed to eliminate study treatment plus 30 days for study treatments with genotoxic potential) after the last dose of study treatment.

inclusion criteria: - adults (≥18 years) with laboratory-confirmed sars cov 2 infection as determined by pcr or other commercial or public health assay, which is fda cleared or approved for emergency use (test results must be obtained within 72 hours of day - a score of grade 3 (hospitalized, requiring supplemental oxygen) or grade 4 (hospitalized, on non-invasive ventilation or high flow oxygen devices) on the 6-point ordinal scale. - willingness and ability to comply with study-related procedures and assessments. - ability to provide informed consent signed by study subject or legally authorized representative. - male and/or female a)male subjects: - a male subject must agree to use contraception as detailed in appendix 12.3 of this protocol during the treatment period and for at least 6 months, corresponding to time needed to eliminate study treatment for both genotoxic and teratogenic study treatments, after the last dose of study treatment. b)female subjects: - a female subject is eligible to participate if she is not pregnant (see appendix 12.3), not planning to get pregnant in the next 6 months, not breastfeeding, and at least 1 of the following conditions applies: i) not a woman of childbearing potential (wocbp) as defined in appendix 12.3. or ii) a wocbp who agrees to follow the contraceptive guidance in appendix 12.3 during the treatment period and for at least 130 days, (5 terminal half lives and, for genotoxic products, an additional 30 days, corresponding to time needed to eliminate study treatment plus 30 days for study treatments with genotoxic potential) after the last dose of study treatment.