Created at Source Raw Value Validated value
Nov. 16, 2021, 6:30 p.m. usa

inclusion criteria: age ≥18 years laboratory-confirmed sars-cov-2 infection as determined by polymerase chain reaction (pcr) or other commercial or public health assay < 7 days prior to screening sars-cov-2 infection with duration at least 7 days (i e may be included on day 7) as determined by onset of symptoms (defined as day 1) 5 liters/minute of oxygen for at least 8 hours to maintain spo2 at ≥93%. a shorter duration is also accepted if presentation is acute, and the patient needs more than 10 liters/minute of oxygen, or high flow nasal cannula or non-invasive ventilation, to maintain spo2 at ≥93%.. crp > 70 mg/l with no non-sars-cov2 infections. values measured up to 48 hours before inclusion are accepted. ferritin > 500 µg/l values measured up to 48 hours before inclusion are accepted. at least two points on a scale of 0-3 where 1 point is awarded for each value of; lymphocytes < 1x 10(9)/l; d-dimer ≥ 0.5 mg/l and; lactate dehydrogenase ≥ 8 microkatal/l. the values do not have to be concurrently positive and may be up to 3 days old at inclusion. ability to provide informed consent signed by study patient willingness and ability to comply with study-related procedures/assessments in fertile females, willing to comply with effective contraceptive methods for up to 3 months after last dose of study drug. these may include surgical sterilization of patient or partner, intrauterine device or condoms. gestagen-only birth control pills (mini-pills), which do not increase the risk of deep venous thrombosis, may also be used. non-fertile woman is defined as more than 12 months of amenorrhea without an alternative medical cause or, in case of ambiguities, an fsh level in the postmenopausal range.

inclusion criteria: age ≥18 years laboratory-confirmed sars-cov-2 infection as determined by polymerase chain reaction (pcr) or other commercial or public health assay < 7 days prior to screening sars-cov-2 infection with duration at least 7 days (i e may be included on day 7) as determined by onset of symptoms (defined as day 1) 5 liters/minute of oxygen for at least 8 hours to maintain spo2 at ≥93%. a shorter duration is also accepted if presentation is acute, and the patient needs more than 10 liters/minute of oxygen, or high flow nasal cannula or non-invasive ventilation, to maintain spo2 at ≥93%.. crp > 70 mg/l with no non-sars-cov2 infections. values measured up to 48 hours before inclusion are accepted. ferritin > 500 µg/l values measured up to 48 hours before inclusion are accepted. at least two points on a scale of 0-3 where 1 point is awarded for each value of; lymphocytes < 1x 10(9)/l; d-dimer ≥ 0.5 mg/l and; lactate dehydrogenase ≥ 8 microkatal/l. the values do not have to be concurrently positive and may be up to 3 days old at inclusion. ability to provide informed consent signed by study patient willingness and ability to comply with study-related procedures/assessments in fertile females, willing to comply with effective contraceptive methods for up to 3 months after last dose of study drug. these may include surgical sterilization of patient or partner, intrauterine device or condoms. gestagen-only birth control pills (mini-pills), which do not increase the risk of deep venous thrombosis, may also be used. non-fertile woman is defined as more than 12 months of amenorrhea without an alternative medical cause or, in case of ambiguities, an fsh level in the postmenopausal range.

Feb. 20, 2021, 12:31 a.m. usa

inclusion criteria: 1. age ≥18 years 2. laboratory-confirmed sars-cov-2 infection as determined by polymerase chain reaction (pcr) or other commercial or public health assay < 7 days prior to screening 3. sars-cov-2 infection with duration at least 7 days (i e may be included on day 7) as determined by onset of symptoms (defined as day 1) 4. 5 liters/minute of oxygen for at least 8 hours to maintain spo2 at ≥93%. a shorter duration is also accepted if presentation is acute, and the patient needs more than 10 liters/minute of oxygen, or high flow nasal cannula or non-invasive ventilation, to maintain spo2 at ≥93%.. 5. crp > 70 mg/l with no non-sars-cov2 infections. values measured up to 48 hours before inclusion are accepted. 6. ferritin > 500 µg/l values measured up to 48 hours before inclusion are accepted. 7. at least two points on a scale of 0-3 where 1 point is awarded for each value of; lymphocytes < 1x 10(9)/l; d-dimer ≥ 0.5 mg/l and; lactate dehydrogenase ≥ 8 microkatal/l. the values do not have to be concurrently positive and may be up to 3 days old at inclusion. 8. ability to provide informed consent signed by study patient 9. willingness and ability to comply with study-related procedures/assessments 10. in fertile females, willing to comply with effective contraceptive methods for up to 3 months after last dose of study drug. these may include surgical sterilization of patient or partner, intrauterine device or condoms. gestagen-only birth control pills (mini-pills), which do not increase the risk of deep venous thrombosis, may also be used. non-fertile woman is defined as more than 12 months of amenorrhea without an alternative medical cause or, in case of ambiguities, an fsh level in the postmenopausal range.

inclusion criteria: 1. age ≥18 years 2. laboratory-confirmed sars-cov-2 infection as determined by polymerase chain reaction (pcr) or other commercial or public health assay < 7 days prior to screening 3. sars-cov-2 infection with duration at least 7 days (i e may be included on day 7) as determined by onset of symptoms (defined as day 1) 4. 5 liters/minute of oxygen for at least 8 hours to maintain spo2 at ≥93%. a shorter duration is also accepted if presentation is acute, and the patient needs more than 10 liters/minute of oxygen, or high flow nasal cannula or non-invasive ventilation, to maintain spo2 at ≥93%.. 5. crp > 70 mg/l with no non-sars-cov2 infections. values measured up to 48 hours before inclusion are accepted. 6. ferritin > 500 µg/l values measured up to 48 hours before inclusion are accepted. 7. at least two points on a scale of 0-3 where 1 point is awarded for each value of; lymphocytes < 1x 10(9)/l; d-dimer ≥ 0.5 mg/l and; lactate dehydrogenase ≥ 8 microkatal/l. the values do not have to be concurrently positive and may be up to 3 days old at inclusion. 8. ability to provide informed consent signed by study patient 9. willingness and ability to comply with study-related procedures/assessments 10. in fertile females, willing to comply with effective contraceptive methods for up to 3 months after last dose of study drug. these may include surgical sterilization of patient or partner, intrauterine device or condoms. gestagen-only birth control pills (mini-pills), which do not increase the risk of deep venous thrombosis, may also be used. non-fertile woman is defined as more than 12 months of amenorrhea without an alternative medical cause or, in case of ambiguities, an fsh level in the postmenopausal range.

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

inclusion criteria: 1. laboratory-confirmed sars-cov-2 infection as determined by polymerase chain reaction (pcr) or other commercial or public health assay 2. sars-cov-2 infection with duration at least 7 days (as determined by onset of symptoms) 3. pao2 (or spo2)/fio2 < 26,8 kpa (200 mm hg) for at least 8 hours, corresponding to 5 liters/minute of oxygen to maintain spo2 at 94%. 4. crp > 70 mg/l with no non-sars-cov2 infections. 5. ferritin > 500 µg/l 6. at least two points on a scale of 0-3 where 1 point is awarded for each value of; lymphocytes < 1x 10(9)/l; d-dimer ≥ 0.5 mg/l and; lactate dehydrogenase ≥ 8 microkatal/l. 7. ability to provide informed consent signed by study patient 8. willingness and ability to comply with study-related procedures/assessments 9. in fertile females, willing to comply with effective contraceptive methods for up to 3 months after last dose of study drug. these may include birth control pills, surgical sterilization of patient or partner or intrauterine device. non-fertile woman is defined as more than 12 months of amenorrhea without an alternative medical cause or, in case of ambiguities, an fsh level in the postmenopausal range.

inclusion criteria: 1. laboratory-confirmed sars-cov-2 infection as determined by polymerase chain reaction (pcr) or other commercial or public health assay 2. sars-cov-2 infection with duration at least 7 days (as determined by onset of symptoms) 3. pao2 (or spo2)/fio2 < 26,8 kpa (200 mm hg) for at least 8 hours, corresponding to 5 liters/minute of oxygen to maintain spo2 at 94%. 4. crp > 70 mg/l with no non-sars-cov2 infections. 5. ferritin > 500 µg/l 6. at least two points on a scale of 0-3 where 1 point is awarded for each value of; lymphocytes < 1x 10(9)/l; d-dimer ≥ 0.5 mg/l and; lactate dehydrogenase ≥ 8 microkatal/l. 7. ability to provide informed consent signed by study patient 8. willingness and ability to comply with study-related procedures/assessments 9. in fertile females, willing to comply with effective contraceptive methods for up to 3 months after last dose of study drug. these may include birth control pills, surgical sterilization of patient or partner or intrauterine device. non-fertile woman is defined as more than 12 months of amenorrhea without an alternative medical cause or, in case of ambiguities, an fsh level in the postmenopausal range.