Created at Source Raw Value Validated value
June 27, 2024, 4 p.m. usa

1. participants who are admitted to hospital or for whom hospital admission is being planned at the time of screening. 2. participants requiring any form of oxygen supplementation at screening. 3. concurrent or planned treatment with other agents with actual or possible direct antiviral activity against sars-cov-2 including remdesivir. 4. prior, concurrent or planned treatment with monoclonal antibodies (mabs) against sars-cov-2 5. have participated in a previous sars-cov-2 vaccine study or outside of a study have received any sars-cov-2 vaccine of any kind. 6. have a history of convalescent covid-19 plasma treatment at screening. 7. fever (temperature ≥38.0° c \[≥100.4° f\]), measured orally, requirement for antipyretics to reduce temperature (administered for fever), and/or respiratory symptoms (cough, dyspnea) at screening. 8. clinical evidence of any significant acute or chronic disease that, in the opinion of the investigator, may place the participant at undue medical risk for study treatment. 9. the participant has had a known (documented) history of serious anaphylactic reaction to blood, any blood-derived plasma product or commercial immunoglobulin, or has known selective immunoglobulin a (iga) deficiency with anti-iga antibodies. 10. decompensated congestive heart failure or renal failure with fluid overload. this includes currently uncontrolled congestive heart failure new york heart association class iii or iv stage heart failure. 11. participants for whom there is limitation of therapeutic effort such as "do not resuscitate" status. 12. currently participating in another interventional clinical trial with investigational medical product or device. 13. participants with known (documented) thrombotic complications to polyclonal intravenous immune globulin (ivig) therapy in the past. 14. participant has medical condition (other than covid-19) that is projected to limit lifespan to ≤ 1 year. 15. participant has history of drug or alcohol abuse within the past 12 months. 16. participant is unwilling to commit to follow-up visits. 17. women who are pregnant or breastfeeding, or if of childbearing potential, unwilling to practice a highly effective method of contraception (oral, injectable, or implanted hormonal methods of contraception, placement of an intrauterine device or intrauterine system, condom, or occlusive cap with spermicidal foam/gel/cream/suppository, male sterilization, or true abstinence) throughout the study. * true abstinence: when this is in line with the preferred and usual lifestyle of the participant. (periodic abstinence \[e.g., calendar, ovulation, symptothermal, post-ovulation methods\], declaration of abstinence for the duration of a trial, and withdrawal are not acceptable methods of contraception). * note: women who are \>55 years and with the absence of menses in the last 12 months are considered to be not of childbearing potential. female participants of childbearing potential must have a negative test for pregnancy blood or urine human chorionic gonadotropin (hcg)-based assay at screening/baseline visit.

1. participants who are admitted to hospital or for whom hospital admission is being planned at the time of screening. 2. participants requiring any form of oxygen supplementation at screening. 3. concurrent or planned treatment with other agents with actual or possible direct antiviral activity against sars-cov-2 including remdesivir. 4. prior, concurrent or planned treatment with monoclonal antibodies (mabs) against sars-cov-2 5. have participated in a previous sars-cov-2 vaccine study or outside of a study have received any sars-cov-2 vaccine of any kind. 6. have a history of convalescent covid-19 plasma treatment at screening. 7. fever (temperature ≥38.0° c \[≥100.4° f\]), measured orally, requirement for antipyretics to reduce temperature (administered for fever), and/or respiratory symptoms (cough, dyspnea) at screening. 8. clinical evidence of any significant acute or chronic disease that, in the opinion of the investigator, may place the participant at undue medical risk for study treatment. 9. the participant has had a known (documented) history of serious anaphylactic reaction to blood, any blood-derived plasma product or commercial immunoglobulin, or has known selective immunoglobulin a (iga) deficiency with anti-iga antibodies. 10. decompensated congestive heart failure or renal failure with fluid overload. this includes currently uncontrolled congestive heart failure new york heart association class iii or iv stage heart failure. 11. participants for whom there is limitation of therapeutic effort such as "do not resuscitate" status. 12. currently participating in another interventional clinical trial with investigational medical product or device. 13. participants with known (documented) thrombotic complications to polyclonal intravenous immune globulin (ivig) therapy in the past. 14. participant has medical condition (other than covid-19) that is projected to limit lifespan to ≤ 1 year. 15. participant has history of drug or alcohol abuse within the past 12 months. 16. participant is unwilling to commit to follow-up visits. 17. women who are pregnant or breastfeeding, or if of childbearing potential, unwilling to practice a highly effective method of contraception (oral, injectable, or implanted hormonal methods of contraception, placement of an intrauterine device or intrauterine system, condom, or occlusive cap with spermicidal foam/gel/cream/suppository, male sterilization, or true abstinence) throughout the study. * true abstinence: when this is in line with the preferred and usual lifestyle of the participant. (periodic abstinence \[e.g., calendar, ovulation, symptothermal, post-ovulation methods\], declaration of abstinence for the duration of a trial, and withdrawal are not acceptable methods of contraception). * note: women who are \>55 years and with the absence of menses in the last 12 months are considered to be not of childbearing potential. female participants of childbearing potential must have a negative test for pregnancy blood or urine human chorionic gonadotropin (hcg)-based assay at screening/baseline visit.

Dec. 9, 2022, 4 a.m. usa

participants who are admitted to hospital or for whom hospital admission is being planned at the time of screening. participants requiring any form of oxygen supplementation at screening. concurrent or planned treatment with other agents with actual or possible direct antiviral activity against sars-cov-2 including remdesivir. prior, concurrent or planned treatment with monoclonal antibodies (mabs) against sars-cov-2 have participated in a previous sars-cov-2 vaccine study or outside of a study have received any sars-cov-2 vaccine of any kind. have a history of convalescent covid-19 plasma treatment at screening. fever (temperature ≥38.0° c [≥100.4° f]), measured orally, requirement for antipyretics to reduce temperature (administered for fever), and/or respiratory symptoms (cough, dyspnea) at screening. clinical evidence of any significant acute or chronic disease that, in the opinion of the investigator, may place the participant at undue medical risk for study treatment. the participant has had a known (documented) history of serious anaphylactic reaction to blood, any blood-derived plasma product or commercial immunoglobulin, or has known selective immunoglobulin a (iga) deficiency with anti-iga antibodies. decompensated congestive heart failure or renal failure with fluid overload. this includes currently uncontrolled congestive heart failure new york heart association class iii or iv stage heart failure. participants for whom there is limitation of therapeutic effort such as "do not resuscitate" status. currently participating in another interventional clinical trial with investigational medical product or device. participants with known (documented) thrombotic complications to polyclonal intravenous immune globulin (ivig) therapy in the past. participant has medical condition (other than covid-19) that is projected to limit lifespan to ≤ 1 year. participant has history of drug or alcohol abuse within the past 12 months. participant is unwilling to commit to follow-up visits. women who are pregnant or breastfeeding, or if of childbearing potential, unwilling to practice a highly effective method of contraception (oral, injectable, or implanted hormonal methods of contraception, placement of an intrauterine device or intrauterine system, condom, or occlusive cap with spermicidal foam/gel/cream/suppository, male sterilization, or true abstinence) throughout the study. true abstinence: when this is in line with the preferred and usual lifestyle of the participant. (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods], declaration of abstinence for the duration of a trial, and withdrawal are not acceptable methods of contraception). note: women who are >55 years and with the absence of menses in the last 12 months are considered to be not of childbearing potential. female participants of childbearing potential must have a negative test for pregnancy blood or urine human chorionic gonadotropin (hcg)-based assay at screening/baseline visit.

participants who are admitted to hospital or for whom hospital admission is being planned at the time of screening. participants requiring any form of oxygen supplementation at screening. concurrent or planned treatment with other agents with actual or possible direct antiviral activity against sars-cov-2 including remdesivir. prior, concurrent or planned treatment with monoclonal antibodies (mabs) against sars-cov-2 have participated in a previous sars-cov-2 vaccine study or outside of a study have received any sars-cov-2 vaccine of any kind. have a history of convalescent covid-19 plasma treatment at screening. fever (temperature ≥38.0° c [≥100.4° f]), measured orally, requirement for antipyretics to reduce temperature (administered for fever), and/or respiratory symptoms (cough, dyspnea) at screening. clinical evidence of any significant acute or chronic disease that, in the opinion of the investigator, may place the participant at undue medical risk for study treatment. the participant has had a known (documented) history of serious anaphylactic reaction to blood, any blood-derived plasma product or commercial immunoglobulin, or has known selective immunoglobulin a (iga) deficiency with anti-iga antibodies. decompensated congestive heart failure or renal failure with fluid overload. this includes currently uncontrolled congestive heart failure new york heart association class iii or iv stage heart failure. participants for whom there is limitation of therapeutic effort such as "do not resuscitate" status. currently participating in another interventional clinical trial with investigational medical product or device. participants with known (documented) thrombotic complications to polyclonal intravenous immune globulin (ivig) therapy in the past. participant has medical condition (other than covid-19) that is projected to limit lifespan to ≤ 1 year. participant has history of drug or alcohol abuse within the past 12 months. participant is unwilling to commit to follow-up visits. women who are pregnant or breastfeeding, or if of childbearing potential, unwilling to practice a highly effective method of contraception (oral, injectable, or implanted hormonal methods of contraception, placement of an intrauterine device or intrauterine system, condom, or occlusive cap with spermicidal foam/gel/cream/suppository, male sterilization, or true abstinence) throughout the study. true abstinence: when this is in line with the preferred and usual lifestyle of the participant. (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods], declaration of abstinence for the duration of a trial, and withdrawal are not acceptable methods of contraception). note: women who are >55 years and with the absence of menses in the last 12 months are considered to be not of childbearing potential. female participants of childbearing potential must have a negative test for pregnancy blood or urine human chorionic gonadotropin (hcg)-based assay at screening/baseline visit.

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

subjects who are admitted to hospital or for whom hospital admission is being planned at the time of screening. subjects requiring any form of oxygen supplementation at screening. concurrent or planned treatment with other agents with actual or possible direct antiviral activity against sars-cov-2 including remdesivir. prior, concurrent or planned treatment with monoclonal antibodies (mabs) against sars-cov-2 have participated in a previous sars-cov-2 vaccine study or outside of a study have received any sars-cov-2 vaccine of any kind. have a history of convalescent covid-19 plasma treatment at screening. fever (temperature ≥38.0° c [≥100.4° f]), measured orally, requirement for antipyretics to reduce temperature (administered for fever), and/or respiratory symptoms (cough, dyspnea) at screening. clinical evidence of any significant acute or chronic disease that, in the opinion of the investigator, may place the subject at undue medical risk for study treatment. the subject has had a known (documented) history of serious anaphylactic reaction to blood, any blood-derived plasma product or commercial immunoglobulin, or has known selective immunoglobulin a (iga) deficiency with anti-iga antibodies. decompensated congestive heart failure or renal failure with fluid overload. this includes currently uncontrolled congestive heart failure new york heart association class iii or iv stage heart failure. subjects for whom there is limitation of therapeutic effort such as "do not resuscitate" status. currently participating in another interventional clinical trial with investigational medical product or device. subjects with known (documented) thrombotic complications to polyclonal intravenous immune globulin (ivig) therapy in the past. subject has medical condition (other than covid-19) that is projected to limit lifespan to ≤ 1 year. subject has history of drug or alcohol abuse within the past 12 months. women who are pregnant or breastfeeding, or if of childbearing potential, unwilling to practice a highly effective method of contraception (oral, injectable, or implanted hormonal methods of contraception, placement of an intrauterine device or intrauterine system, condom, or occlusive cap with spermicidal foam/gel/cream/suppository, male sterilization, or true abstinence) throughout the study.

subjects who are admitted to hospital or for whom hospital admission is being planned at the time of screening. subjects requiring any form of oxygen supplementation at screening. concurrent or planned treatment with other agents with actual or possible direct antiviral activity against sars-cov-2 including remdesivir. prior, concurrent or planned treatment with monoclonal antibodies (mabs) against sars-cov-2 have participated in a previous sars-cov-2 vaccine study or outside of a study have received any sars-cov-2 vaccine of any kind. have a history of convalescent covid-19 plasma treatment at screening. fever (temperature ≥38.0° c [≥100.4° f]), measured orally, requirement for antipyretics to reduce temperature (administered for fever), and/or respiratory symptoms (cough, dyspnea) at screening. clinical evidence of any significant acute or chronic disease that, in the opinion of the investigator, may place the subject at undue medical risk for study treatment. the subject has had a known (documented) history of serious anaphylactic reaction to blood, any blood-derived plasma product or commercial immunoglobulin, or has known selective immunoglobulin a (iga) deficiency with anti-iga antibodies. decompensated congestive heart failure or renal failure with fluid overload. this includes currently uncontrolled congestive heart failure new york heart association class iii or iv stage heart failure. subjects for whom there is limitation of therapeutic effort such as "do not resuscitate" status. currently participating in another interventional clinical trial with investigational medical product or device. subjects with known (documented) thrombotic complications to polyclonal intravenous immune globulin (ivig) therapy in the past. subject has medical condition (other than covid-19) that is projected to limit lifespan to ≤ 1 year. subject has history of drug or alcohol abuse within the past 12 months. women who are pregnant or breastfeeding, or if of childbearing potential, unwilling to practice a highly effective method of contraception (oral, injectable, or implanted hormonal methods of contraception, placement of an intrauterine device or intrauterine system, condom, or occlusive cap with spermicidal foam/gel/cream/suppository, male sterilization, or true abstinence) throughout the study.

May 22, 2021, 12:32 a.m. usa

1. subjects who are admitted to hospital or for whom hospital admission is being planned at the time of screening. 2. subjects requiring any form of oxygen supplementation at screening. 3. concurrent or planned treatment with other agents with actual or possible direct antiviral activity against sars-cov-2 including remdesivir. 4. prior, concurrent or planned treatment with monoclonal antibodies (mabs) against sars-cov-2 5. have participated in a previous sars-cov-2 vaccine study or outside of a study have received any sars-cov-2 vaccine of any kind. 6. have a history of convalescent covid-19 plasma treatment at screening. 7. fever (temperature ≥38.0° c [≥100.4° f]), measured orally, requirement for antipyretics to reduce temperature (administered for fever), and/or respiratory symptoms (cough, dyspnea) at screening. 8. clinical evidence of any significant acute or chronic disease that, in the opinion of the investigator, may place the subject at undue medical risk for study treatment. 9. the subject has had a known (documented) history of serious anaphylactic reaction to blood, any blood-derived plasma product or commercial immunoglobulin, or has known selective immunoglobulin a (iga) deficiency with anti-iga antibodies. 10. decompensated congestive heart failure or renal failure with fluid overload. this includes currently uncontrolled congestive heart failure new york heart association class iii or iv stage heart failure. 11. subjects for whom there is limitation of therapeutic effort such as "do not resuscitate" status. 12. currently participating in another interventional clinical trial with investigational medical product or device. 13. subjects with known (documented) thrombotic complications to polyclonal intravenous immune globulin (ivig) therapy in the past. 14. subject has medical condition (other than covid-19) that is projected to limit lifespan to ≤ 1 year. 15. subject has history of drug or alcohol abuse within the past 12 months. 16. women who are pregnant or breastfeeding, or if of childbearing potential, unwilling to practice a highly effective method of contraception (oral, injectable, or implanted hormonal methods of contraception, placement of an intrauterine device or intrauterine system, condom, or occlusive cap with spermicidal foam/gel/cream/suppository, male sterilization, or true abstinence) throughout the study.

1. subjects who are admitted to hospital or for whom hospital admission is being planned at the time of screening. 2. subjects requiring any form of oxygen supplementation at screening. 3. concurrent or planned treatment with other agents with actual or possible direct antiviral activity against sars-cov-2 including remdesivir. 4. prior, concurrent or planned treatment with monoclonal antibodies (mabs) against sars-cov-2 5. have participated in a previous sars-cov-2 vaccine study or outside of a study have received any sars-cov-2 vaccine of any kind. 6. have a history of convalescent covid-19 plasma treatment at screening. 7. fever (temperature ≥38.0° c [≥100.4° f]), measured orally, requirement for antipyretics to reduce temperature (administered for fever), and/or respiratory symptoms (cough, dyspnea) at screening. 8. clinical evidence of any significant acute or chronic disease that, in the opinion of the investigator, may place the subject at undue medical risk for study treatment. 9. the subject has had a known (documented) history of serious anaphylactic reaction to blood, any blood-derived plasma product or commercial immunoglobulin, or has known selective immunoglobulin a (iga) deficiency with anti-iga antibodies. 10. decompensated congestive heart failure or renal failure with fluid overload. this includes currently uncontrolled congestive heart failure new york heart association class iii or iv stage heart failure. 11. subjects for whom there is limitation of therapeutic effort such as "do not resuscitate" status. 12. currently participating in another interventional clinical trial with investigational medical product or device. 13. subjects with known (documented) thrombotic complications to polyclonal intravenous immune globulin (ivig) therapy in the past. 14. subject has medical condition (other than covid-19) that is projected to limit lifespan to ≤ 1 year. 15. subject has history of drug or alcohol abuse within the past 12 months. 16. women who are pregnant or breastfeeding, or if of childbearing potential, unwilling to practice a highly effective method of contraception (oral, injectable, or implanted hormonal methods of contraception, placement of an intrauterine device or intrauterine system, condom, or occlusive cap with spermicidal foam/gel/cream/suppository, male sterilization, or true abstinence) throughout the study.

April 22, 2021, 12:31 a.m. usa

1. subjects who are admitted to hospital or for whom hospital admission is being planned at the time of screening. 2. subjects requiring any form of oxygen supplementation at screening. 3. concurrent or planned treatment with other agents with actual or possible direct antiviral activity against sars-cov-2 including remdesivir. 4. prior, concurrent or planned treatment with monoclonal antibodies (mabs) against sars-cov-2 5. have participated in a previous sars-cov-2 vaccine study or outside of a study have received any sars-cov-2 vaccine of any kind. 6. have a history of convalescent covid-19 plasma treatment at screening. 7. fever (temperature >38.0° c [>100.4° f]), requirement for antipyretics to reduce temperature (administered for fever), and/or respiratory symptoms (cough, dyspnea) at screening. 8. clinical evidence of any significant acute or chronic disease that, in the opinion of the investigator, may place the subject at undue medical risk for study treatment. 9. the subject has had a known (documented) history of serious anaphylactic reaction to blood, any blood-derived plasma product or commercial immunoglobulin, or has known selective immunoglobulin a (iga) deficiency with anti-iga antibodies. 10. decompensated congestive heart failure or renal failure with fluid overload. this includes currently uncontrolled congestive heart failure new york heart association class iii or iv stage heart failure. 11. subjects for whom there is limitation of therapeutic effort such as "do not resuscitate" status. 12. currently participating in another interventional clinical trial with investigational medical product or device. 13. subjects with known (documented) thrombotic complications to polyclonal intravenous immune globulin (ivig) therapy in the past. 14. subject has medical condition (other than covid-19) that is projected to limit lifespan to ≤ 1 year. 15. subject has history of drug or alcohol abuse within the past 12 months. 16. women who are pregnant or breastfeeding, or if of childbearing potential, unwilling to practice a highly effective method of contraception (oral, injectable, or implanted hormonal methods of contraception, placement of an intrauterine device or intrauterine system, condom, or occlusive cap with spermicidal foam/gel/cream/suppository, male sterilization, or true abstinence) throughout the study.

1. subjects who are admitted to hospital or for whom hospital admission is being planned at the time of screening. 2. subjects requiring any form of oxygen supplementation at screening. 3. concurrent or planned treatment with other agents with actual or possible direct antiviral activity against sars-cov-2 including remdesivir. 4. prior, concurrent or planned treatment with monoclonal antibodies (mabs) against sars-cov-2 5. have participated in a previous sars-cov-2 vaccine study or outside of a study have received any sars-cov-2 vaccine of any kind. 6. have a history of convalescent covid-19 plasma treatment at screening. 7. fever (temperature >38.0° c [>100.4° f]), requirement for antipyretics to reduce temperature (administered for fever), and/or respiratory symptoms (cough, dyspnea) at screening. 8. clinical evidence of any significant acute or chronic disease that, in the opinion of the investigator, may place the subject at undue medical risk for study treatment. 9. the subject has had a known (documented) history of serious anaphylactic reaction to blood, any blood-derived plasma product or commercial immunoglobulin, or has known selective immunoglobulin a (iga) deficiency with anti-iga antibodies. 10. decompensated congestive heart failure or renal failure with fluid overload. this includes currently uncontrolled congestive heart failure new york heart association class iii or iv stage heart failure. 11. subjects for whom there is limitation of therapeutic effort such as "do not resuscitate" status. 12. currently participating in another interventional clinical trial with investigational medical product or device. 13. subjects with known (documented) thrombotic complications to polyclonal intravenous immune globulin (ivig) therapy in the past. 14. subject has medical condition (other than covid-19) that is projected to limit lifespan to ≤ 1 year. 15. subject has history of drug or alcohol abuse within the past 12 months. 16. women who are pregnant or breastfeeding, or if of childbearing potential, unwilling to practice a highly effective method of contraception (oral, injectable, or implanted hormonal methods of contraception, placement of an intrauterine device or intrauterine system, condom, or occlusive cap with spermicidal foam/gel/cream/suppository, male sterilization, or true abstinence) throughout the study.