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

inclusion criteria: 1. admitted to a hospital with symptoms suggestive of coronavirus disease 2019 (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 severe acute respiratory syndrome coronavirus 2 (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 score 5, 6, or 7). 7. women of childbearing potential must agree to either abstinence or use at least one acceptable method of contraception\* from the time of screening through 5 months post study intraperitoneal (ip) dosing. \* 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 coronavirus disease 2019 (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 severe acute respiratory syndrome coronavirus 2 (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 score 5, 6, or 7). 7. women of childbearing potential must agree to either abstinence or use at least one acceptable method of contraception\* from the time of screening through 5 months post study intraperitoneal (ip) dosing. \* 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.

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

inclusion criteria: admitted to a hospital with symptoms suggestive of coronavirus disease 2019 (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 severe acute respiratory syndrome coronavirus 2 (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 score 5, 6, or 7). women of childbearing potential must agree to either abstinence or use at least one acceptable method of contraception* from the time of screening through 5 months post study intraperitoneal (ip) dosing. * 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 coronavirus disease 2019 (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 severe acute respiratory syndrome coronavirus 2 (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 score 5, 6, or 7). women of childbearing potential must agree to either abstinence or use at least one acceptable method of contraception* from the time of screening through 5 months post study intraperitoneal (ip) dosing. * 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.

July 31, 2021, 1 p.m. usa

inclusion criteria: 1. admitted to a hospital with symptoms suggestive of coronavirus disease 2019 (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 severe acute respiratory syndrome coronavirus 2 (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 score 5, 6, or 7). 7. women of childbearing potential must agree to either abstinence or use at least one acceptable method of contraception* from the time of screening through 5 months post study intraperitoneal (ip) dosing. * 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 coronavirus disease 2019 (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 severe acute respiratory syndrome coronavirus 2 (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 score 5, 6, or 7). 7. women of childbearing potential must agree to either abstinence or use at least one acceptable method of contraception* from the time of screening through 5 months post study intraperitoneal (ip) dosing. * 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.

June 3, 2021, 12:32 a.m. usa

inclusion criteria: 1. admitted to a hospital with symptoms suggestive of coronavirus disease 2019 (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 severe acute respiratory syndrome coronavirus 2 (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 must agree to either abstinence or use at least one acceptable method of contraception* from the time of screening through 5 months post study intraperitoneal (ip) dosing. * 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 coronavirus disease 2019 (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 severe acute respiratory syndrome coronavirus 2 (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 must agree to either abstinence or use at least one acceptable method of contraception* from the time of screening through 5 months post study intraperitoneal (ip) dosing. * 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.

Jan. 29, 2021, 12:31 a.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. has laboratory-confirmed sars-cov-2 infection as determined by polymerase chain reaction (pcr) or other commercial or public health assay in any specimen, as documented by either of the following: - pcr positive in sample collected < 72 hours prior to screening; or - pcr positive in sample collected >/= 72 hours but < 14 days prior to screening and non-improving or progressive disease suggestive of ongoing sars-cov-2 infection. note: if written documentation of the positive test result is not available at the time of enrollment (e.g., report came from other institution), the subject may be enrolled but the pcr should be repeated at the time of enrollment. 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 must agree to either abstinence or use at least one acceptable method of contraception* from the time of screening through 5 months post study intraperitoneal (ip) dosing. * 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. has laboratory-confirmed sars-cov-2 infection as determined by polymerase chain reaction (pcr) or other commercial or public health assay in any specimen, as documented by either of the following: - pcr positive in sample collected < 72 hours prior to screening; or - pcr positive in sample collected >/= 72 hours but < 14 days prior to screening and non-improving or progressive disease suggestive of ongoing sars-cov-2 infection. note: if written documentation of the positive test result is not available at the time of enrollment (e.g., report came from other institution), the subject may be enrolled but the pcr should be repeated at the time of enrollment. 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 must agree to either abstinence or use at least one acceptable method of contraception* from the time of screening through 5 months post study intraperitoneal (ip) dosing. * 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.

Oct. 26, 2020, 11:31 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. has laboratory-confirmed sars-cov-2 infection as determined by polymerase chain reaction (pcr) or other commercial or public health assay in any specimen, as documented by either of the following: - pcr positive in sample collected < 72 hours prior to randomization; or - pcr positive in sample collected >/= 72 hours prior to randomization, but < 7 days prior to randomization and progressive disease suggestive of ongoing sars-cov-2 infection. note: if written documentation of the positive test result is not available at the time of enrollment (e.g., report came from other institution), the subject may be enrolled but the pcr should be repeated at the time of enrollment. 6. illness of any duration, and requiring supplemental oxygen, mechanical ventilation or extracorporeal membrane oxygenation (ecmo). 7. women of childbearing potential must agree to either abstinence or use at least one primary form of contraception* not including hormonal contraception from the time of screening through 5 months. * acceptable methods include barrier contraceptives (condoms or diaphragm) with spermicide, intrauterine devices (iuds), hormonal contraceptives, oral contraceptive pills, and surgical sterilization. 8. agrees to not participate in another clinical trial (both pharmacologic and other types of interventions) for the treatment of covid-19 through day 60.

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. has laboratory-confirmed sars-cov-2 infection as determined by polymerase chain reaction (pcr) or other commercial or public health assay in any specimen, as documented by either of the following: - pcr positive in sample collected < 72 hours prior to randomization; or - pcr positive in sample collected >/= 72 hours prior to randomization, but < 7 days prior to randomization and progressive disease suggestive of ongoing sars-cov-2 infection. note: if written documentation of the positive test result is not available at the time of enrollment (e.g., report came from other institution), the subject may be enrolled but the pcr should be repeated at the time of enrollment. 6. illness of any duration, and requiring supplemental oxygen, mechanical ventilation or extracorporeal membrane oxygenation (ecmo). 7. women of childbearing potential must agree to either abstinence or use at least one primary form of contraception* not including hormonal contraception from the time of screening through 5 months. * acceptable methods include barrier contraceptives (condoms or diaphragm) with spermicide, intrauterine devices (iuds), hormonal contraceptives, oral contraceptive pills, and surgical sterilization. 8. agrees to not participate in another clinical trial (both pharmacologic and other types of interventions) for the treatment of covid-19 through day 60.