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

inclusion criteria: 1. admitted to a hospital with symptoms suggestive of covid-19 and requires ongoing medical care. 2. subject (or legally authorized representative) provides informed consent prior to initiation of any study procedures. 3. subject (or legally authorized representative) understands and agrees to comply with planned study procedures. 4. male or non-pregnant female adult \>/=18 years of age at time of enrollment. 5. illness of any duration and has laboratory-confirmed sars-cov-2 infection as determined by polymerase chain reaction (pcr) or other commercial or public health assay (e.g., nucleic acid amplification test \[naat\], antigen test) in any respiratory specimen or saliva \</=14 days prior to randomization. 6. illness of any duration, and requiring, just prior to randomization, supplemental oxygen (any flow), mechanical ventilation or extracorporeal membrane oxygenation (ecmo) (ordinal scale category 5, 6, or 7).\* \*if written documentation of the positive test result is not available at the time of enrollment (e.g., report came from other institution), the test should be repeated and the subject may be enrolled if positive. 7. women of childbearing potential and men must agree to either abstinence or use at least one acceptable method of contraception\*\* from the time of screening through 30 days after the last dose of danicopan for women and 90 days after the last dose for men. \*\*acceptable methods include barrier contraceptives (condoms or diaphragm) with spermicide, intrauterine devices (iuds), hormonal contraceptives, oral contraceptive pills, and surgical sterilization. 8. agrees not to participate in another blinded clinical trial (both pharmacologic and other types of interventions) for the treatment of covid-19 through day 29

inclusion criteria: 1. admitted to a hospital with symptoms suggestive of covid-19 and requires ongoing medical care. 2. subject (or legally authorized representative) provides informed consent prior to initiation of any study procedures. 3. subject (or legally authorized representative) understands and agrees to comply with planned study procedures. 4. male or non-pregnant female adult \>/=18 years of age at time of enrollment. 5. illness of any duration and has laboratory-confirmed sars-cov-2 infection as determined by polymerase chain reaction (pcr) or other commercial or public health assay (e.g., nucleic acid amplification test \[naat\], antigen test) in any respiratory specimen or saliva \</=14 days prior to randomization. 6. illness of any duration, and requiring, just prior to randomization, supplemental oxygen (any flow), mechanical ventilation or extracorporeal membrane oxygenation (ecmo) (ordinal scale category 5, 6, or 7).\* \*if written documentation of the positive test result is not available at the time of enrollment (e.g., report came from other institution), the test should be repeated and the subject may be enrolled if positive. 7. women of childbearing potential and men must agree to either abstinence or use at least one acceptable method of contraception\*\* from the time of screening through 30 days after the last dose of danicopan for women and 90 days after the last dose for men. \*\*acceptable methods include barrier contraceptives (condoms or diaphragm) with spermicide, intrauterine devices (iuds), hormonal contraceptives, oral contraceptive pills, and surgical sterilization. 8. agrees not to participate in another blinded clinical trial (both pharmacologic and other types of interventions) for the treatment of covid-19 through day 29

Dec. 7, 2021, 12:30 a.m. usa

inclusion criteria: admitted to a hospital with symptoms suggestive of covid-19 and requires ongoing medical care. subject (or legally authorized representative) provides informed consent prior to initiation of any study procedures. subject (or legally authorized representative) understands and agrees to comply with planned study procedures. male or non-pregnant female adult >/=18 years of age at time of enrollment. illness of any duration and has laboratory-confirmed sars-cov-2 infection as determined by polymerase chain reaction (pcr) or other commercial or public health assay (e.g., nucleic acid amplification test [naat], antigen test) in any respiratory specimen or saliva </=14 days prior to randomization. illness of any duration, and requiring, just prior to randomization, supplemental oxygen (any flow), mechanical ventilation or extracorporeal membrane oxygenation (ecmo) (ordinal scale category 5, 6, or 7).* *if written documentation of the positive test result is not available at the time of enrollment (e.g., report came from other institution), the test should be repeated and the subject may be enrolled if positive. women of childbearing potential and men must agree to either abstinence or use at least one acceptable method of contraception** from the time of screening through 30 days after the last dose of danicopan for women and 90 days after the last dose for men. **acceptable methods include barrier contraceptives (condoms or diaphragm) with spermicide, intrauterine devices (iuds), hormonal contraceptives, oral contraceptive pills, and surgical sterilization. agrees not to participate in another blinded clinical trial (both pharmacologic and other types of interventions) for the treatment of covid-19 through day 29

inclusion criteria: admitted to a hospital with symptoms suggestive of covid-19 and requires ongoing medical care. subject (or legally authorized representative) provides informed consent prior to initiation of any study procedures. subject (or legally authorized representative) understands and agrees to comply with planned study procedures. male or non-pregnant female adult >/=18 years of age at time of enrollment. illness of any duration and has laboratory-confirmed sars-cov-2 infection as determined by polymerase chain reaction (pcr) or other commercial or public health assay (e.g., nucleic acid amplification test [naat], antigen test) in any respiratory specimen or saliva </=14 days prior to randomization. illness of any duration, and requiring, just prior to randomization, supplemental oxygen (any flow), mechanical ventilation or extracorporeal membrane oxygenation (ecmo) (ordinal scale category 5, 6, or 7).* *if written documentation of the positive test result is not available at the time of enrollment (e.g., report came from other institution), the test should be repeated and the subject may be enrolled if positive. women of childbearing potential and men must agree to either abstinence or use at least one acceptable method of contraception** from the time of screening through 30 days after the last dose of danicopan for women and 90 days after the last dose for men. **acceptable methods include barrier contraceptives (condoms or diaphragm) with spermicide, intrauterine devices (iuds), hormonal contraceptives, oral contraceptive pills, and surgical sterilization. agrees not to participate in another blinded clinical trial (both pharmacologic and other types of interventions) for the treatment of covid-19 through day 29

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

inclusion criteria: admitted to a hospital with symptoms suggestive of covid-19 and requires ongoing medical care. subject (or legally authorized representative) provides informed consent prior to initiation of any study procedures. subject (or legally authorized representative) understands and agrees to comply with planned study procedures. male or non-pregnant female adult >/=18 years of age at time of enrollment. illness of any duration and has laboratory-confirmed sars-cov-2 infection as determined by polymerase chain reaction (pcr) or other commercial or public health assay (e.g., nucleic acid amplification test [naat], antigen test) in any respiratory specimen or saliva </=14 days prior to randomization. illness of any duration, and requiring, just prior to randomization, supplemental oxygen (any flow), mechanical ventilation or extracorporeal membrane oxygenation (ecmo) (ordinal scale category 5, 6, or 7). women of childbearing potential and men must agree to either abstinence or use at least one acceptable method of contraception* from the time of screening through 30 days after the last dose of danicopan for women and 90 days after the last dose for men. *acceptable methods include barrier contraceptives (condoms or diaphragm) with spermicide, intrauterine devices (iuds), hormonal contraceptives, oral contraceptive pills, and surgical sterilization. agrees not to participate in another blinded clinical trial (both pharmacologic and other types of interventions) for the treatment of covid-19 through day 29

inclusion criteria: admitted to a hospital with symptoms suggestive of covid-19 and requires ongoing medical care. subject (or legally authorized representative) provides informed consent prior to initiation of any study procedures. subject (or legally authorized representative) understands and agrees to comply with planned study procedures. male or non-pregnant female adult >/=18 years of age at time of enrollment. illness of any duration and has laboratory-confirmed sars-cov-2 infection as determined by polymerase chain reaction (pcr) or other commercial or public health assay (e.g., nucleic acid amplification test [naat], antigen test) in any respiratory specimen or saliva </=14 days prior to randomization. illness of any duration, and requiring, just prior to randomization, supplemental oxygen (any flow), mechanical ventilation or extracorporeal membrane oxygenation (ecmo) (ordinal scale category 5, 6, or 7). women of childbearing potential and men must agree to either abstinence or use at least one acceptable method of contraception* from the time of screening through 30 days after the last dose of danicopan for women and 90 days after the last dose for men. *acceptable methods include barrier contraceptives (condoms or diaphragm) with spermicide, intrauterine devices (iuds), hormonal contraceptives, oral contraceptive pills, and surgical sterilization. agrees not to participate in another blinded clinical trial (both pharmacologic and other types of interventions) for the treatment of covid-19 through day 29

Aug. 4, 2021, 2 p.m. usa

inclusion criteria: 1. admitted to a hospital with symptoms suggestive of covid-19 and requires ongoing medical care. 2. subject (or legally authorized representative) provides informed consent prior to initiation of any study procedures. 3. subject (or legally authorized representative) understands and agrees to comply with planned study procedures. 4. male or non-pregnant female adult >/=18 years of age at time of enrollment. 5. illness of any duration and has laboratory-confirmed sars-cov-2 infection as determined by polymerase chain reaction (pcr) or other commercial or public health assay (e.g., nucleic acid amplification test [naat], antigen test) in any respiratory specimen or saliva </=14 days prior to randomization. 6. illness of any duration, and requiring, just prior to randomization, supplemental oxygen (any flow), mechanical ventilation or extracorporeal membrane oxygenation (ecmo) (ordinal scale category 5, 6, or 7). 7. women of childbearing potential and men must agree to either abstinence or use at least one acceptable method of contraception* from the time of screening through 30 days after the last dose of danicopan for women and 90 days after the last dose for men. *acceptable methods include barrier contraceptives (condoms or diaphragm) with spermicide, intrauterine devices (iuds), hormonal contraceptives, oral contraceptive pills, and surgical sterilization. 8. agrees not to participate in another blinded clinical trial (both pharmacologic and other types of interventions) for the treatment of covid-19 through day 29

inclusion criteria: 1. admitted to a hospital with symptoms suggestive of covid-19 and requires ongoing medical care. 2. subject (or legally authorized representative) provides informed consent prior to initiation of any study procedures. 3. subject (or legally authorized representative) understands and agrees to comply with planned study procedures. 4. male or non-pregnant female adult >/=18 years of age at time of enrollment. 5. illness of any duration and has laboratory-confirmed sars-cov-2 infection as determined by polymerase chain reaction (pcr) or other commercial or public health assay (e.g., nucleic acid amplification test [naat], antigen test) in any respiratory specimen or saliva </=14 days prior to randomization. 6. illness of any duration, and requiring, just prior to randomization, supplemental oxygen (any flow), mechanical ventilation or extracorporeal membrane oxygenation (ecmo) (ordinal scale category 5, 6, or 7). 7. women of childbearing potential and men must agree to either abstinence or use at least one acceptable method of contraception* from the time of screening through 30 days after the last dose of danicopan for women and 90 days after the last dose for men. *acceptable methods include barrier contraceptives (condoms or diaphragm) with spermicide, intrauterine devices (iuds), hormonal contraceptives, oral contraceptive pills, and surgical sterilization. 8. agrees not to participate in another blinded clinical trial (both pharmacologic and other types of interventions) for the treatment of covid-19 through day 29