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

inclusion criteria: subjects who meet all of the following criteria will be eligible to participate in the study: 1. must have provided informed consent in a manner approved by the investigator's institutional review board (irb) or independent ethics committee (iec) prior to any assessments. if a patient is unable to provide informed consent due to their medical condition, the patient's legally authorized representative may consent on behalf of the study patient, as permitted by local law and institutional standard operating procedures; 2. age range: 19-85 years old 3. male or female gender 4. confirmed sars-cov-2 infection by nasopharyngeal swab pcr or serum assay for igm antibody 5. requiring hospital but not mechanical ventilation 6. oxygen supplementation not greater than 10l delivered by any device 7. with evidence of severe covid-19 (at least 2 of the following): 1. fever \> 38c within 72 hours 2. pulmonary infiltrate on cxr 3. need for supplemental o2 to maintain saturation \> 92% 8. and at least 1 of the following: 1. ferritin \> 500 ng/ml 2. crp \> 50 mg/l 3. ldh \>250 u/l 4. d-dimer \> 1000 ng/ml 9. women of childbearing potential (ie, not post-menopausal or surgically sterilized) must have a negative highly sensitive urine or serum pregnancy test before randomization. participating women of childbearing potential must be willing to consistently use effective methods of contraception (ie, condom, combined oral contraceptive, implant, injectable, indwelling intrauterine device, or a vasectomized partner) from screening until at least 90 days after administration of the last dose of study drug; 10. the subject must be willing and able to provide informed consent and abide all study requirements and restrictions.

inclusion criteria: subjects who meet all of the following criteria will be eligible to participate in the study: 1. must have provided informed consent in a manner approved by the investigator's institutional review board (irb) or independent ethics committee (iec) prior to any assessments. if a patient is unable to provide informed consent due to their medical condition, the patient's legally authorized representative may consent on behalf of the study patient, as permitted by local law and institutional standard operating procedures; 2. age range: 19-85 years old 3. male or female gender 4. confirmed sars-cov-2 infection by nasopharyngeal swab pcr or serum assay for igm antibody 5. requiring hospital but not mechanical ventilation 6. oxygen supplementation not greater than 10l delivered by any device 7. with evidence of severe covid-19 (at least 2 of the following): 1. fever \> 38c within 72 hours 2. pulmonary infiltrate on cxr 3. need for supplemental o2 to maintain saturation \> 92% 8. and at least 1 of the following: 1. ferritin \> 500 ng/ml 2. crp \> 50 mg/l 3. ldh \>250 u/l 4. d-dimer \> 1000 ng/ml 9. women of childbearing potential (ie, not post-menopausal or surgically sterilized) must have a negative highly sensitive urine or serum pregnancy test before randomization. participating women of childbearing potential must be willing to consistently use effective methods of contraception (ie, condom, combined oral contraceptive, implant, injectable, indwelling intrauterine device, or a vasectomized partner) from screening until at least 90 days after administration of the last dose of study drug; 10. the subject must be willing and able to provide informed consent and abide all study requirements and restrictions.

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

inclusion criteria: subjects who meet all of the following criteria will be eligible to participate in the study: must have provided informed consent in a manner approved by the investigator's institutional review board (irb) or independent ethics committee (iec) prior to any assessments. if a patient is unable to provide informed consent due to their medical condition, the patient's legally authorized representative may consent on behalf of the study patient, as permitted by local law and institutional standard operating procedures; age range: 19-85 years old male or female gender confirmed sars-cov-2 infection by nasopharyngeal swab pcr or serum assay for igm antibody requiring hospital but not mechanical ventilation oxygen supplementation not greater than 10l delivered by any device with evidence of severe covid-19 (at least 2 of the following): fever > 38c within 72 hours pulmonary infiltrate on cxr need for supplemental o2 to maintain saturation > 92% and at least 1 of the following: ferritin > 500 ng/ml crp > 50 mg/l ldh >250 u/l d-dimer > 1000 ng/ml women of childbearing potential (ie, not post-menopausal or surgically sterilized) must have a negative highly sensitive urine or serum pregnancy test before randomization. participating women of childbearing potential must be willing to consistently use effective methods of contraception (ie, condom, combined oral contraceptive, implant, injectable, indwelling intrauterine device, or a vasectomized partner) from screening until at least 90 days after administration of the last dose of study drug; the subject must be willing and able to provide informed consent and abide all study requirements and restrictions.

inclusion criteria: subjects who meet all of the following criteria will be eligible to participate in the study: must have provided informed consent in a manner approved by the investigator's institutional review board (irb) or independent ethics committee (iec) prior to any assessments. if a patient is unable to provide informed consent due to their medical condition, the patient's legally authorized representative may consent on behalf of the study patient, as permitted by local law and institutional standard operating procedures; age range: 19-85 years old male or female gender confirmed sars-cov-2 infection by nasopharyngeal swab pcr or serum assay for igm antibody requiring hospital but not mechanical ventilation oxygen supplementation not greater than 10l delivered by any device with evidence of severe covid-19 (at least 2 of the following): fever > 38c within 72 hours pulmonary infiltrate on cxr need for supplemental o2 to maintain saturation > 92% and at least 1 of the following: ferritin > 500 ng/ml crp > 50 mg/l ldh >250 u/l d-dimer > 1000 ng/ml women of childbearing potential (ie, not post-menopausal or surgically sterilized) must have a negative highly sensitive urine or serum pregnancy test before randomization. participating women of childbearing potential must be willing to consistently use effective methods of contraception (ie, condom, combined oral contraceptive, implant, injectable, indwelling intrauterine device, or a vasectomized partner) from screening until at least 90 days after administration of the last dose of study drug; the subject must be willing and able to provide informed consent and abide all study requirements and restrictions.

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

inclusion criteria: subjects who meet all of the following criteria will be eligible to participate in the study: 1. must have provided informed consent in a manner approved by the investigator's institutional review board (irb) or independent ethics committee (iec) prior to any assessments. if a patient is unable to provide informed consent due to their medical condition, the patient's legally authorized representative may consent on behalf of the study patient, as permitted by local law and institutional standard operating procedures; 2. age range: 19-85 years old 3. male or female gender 4. confirmed sars-cov-2 infection by nasopharyngeal swab pcr or serum assay for igm antibody 5. requiring hospital but not mechanical ventilation 6. oxygen supplementation not greater than 10l delivered by any device 7. with evidence of severe covid-19 (at least 2 of the following): 1. fever > 38c within 72 hours 2. pulmonary infiltrate on cxr 3. need for supplemental o2 to maintain saturation > 92% 8. and at least 1 of the following: 1. ferritin > 500 ng/ml 2. crp > 50 mg/l 3. ldh >250 u/l 4. d-dimer > 1000 ng/ml 9. women of childbearing potential (ie, not post-menopausal or surgically sterilized) must have a negative highly sensitive urine or serum pregnancy test before randomization. participating women of childbearing potential must be willing to consistently use effective methods of contraception (ie, condom, combined oral contraceptive, implant, injectable, indwelling intrauterine device, or a vasectomized partner) from screening until at least 90 days after administration of the last dose of study drug; 10. the subject must be willing and able to provide informed consent and abide all study requirements and restrictions.

inclusion criteria: subjects who meet all of the following criteria will be eligible to participate in the study: 1. must have provided informed consent in a manner approved by the investigator's institutional review board (irb) or independent ethics committee (iec) prior to any assessments. if a patient is unable to provide informed consent due to their medical condition, the patient's legally authorized representative may consent on behalf of the study patient, as permitted by local law and institutional standard operating procedures; 2. age range: 19-85 years old 3. male or female gender 4. confirmed sars-cov-2 infection by nasopharyngeal swab pcr or serum assay for igm antibody 5. requiring hospital but not mechanical ventilation 6. oxygen supplementation not greater than 10l delivered by any device 7. with evidence of severe covid-19 (at least 2 of the following): 1. fever > 38c within 72 hours 2. pulmonary infiltrate on cxr 3. need for supplemental o2 to maintain saturation > 92% 8. and at least 1 of the following: 1. ferritin > 500 ng/ml 2. crp > 50 mg/l 3. ldh >250 u/l 4. d-dimer > 1000 ng/ml 9. women of childbearing potential (ie, not post-menopausal or surgically sterilized) must have a negative highly sensitive urine or serum pregnancy test before randomization. participating women of childbearing potential must be willing to consistently use effective methods of contraception (ie, condom, combined oral contraceptive, implant, injectable, indwelling intrauterine device, or a vasectomized partner) from screening until at least 90 days after administration of the last dose of study drug; 10. the subject must be willing and able to provide informed consent and abide all study requirements and restrictions.