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

1. participant with active sars-cov-2 infection, verified by rt-pcr test 2. participants tested positive for human immunodeficiency virus (hiv antibody screen), hepatitis b virus (hbsag screen) or hepatitis c virus (hcv antibody screen) 3. history of administration of any investigational or non-registered drug within 30 days or 5 half-lives, whichever is longer, prior to administration of study drug, or planned administration during the course of study participation 4. history of any reaction to monoclonal antibodies 5. history of clinically relevant atopic diseases and/or known allergies to the trial product or its components 6. history of any major pulmonary, cardiovascular, renal, neurological (e.g., cerebrovascular events), metabolic, gastrointestinal, hepato-biliary, or hematological functional abnormality, malignancy (except for adequately treated basal cell carcinoma or squamous cell carcinoma of the skin), or mental disability as per discretion of the investigator 7. any clinically significant laboratory findings at screening and enrolment and at day-1; one retest is allowed at screening and/or at day-1 8. acute illness (moderate or severe) and/or fever (body temperature ≥ 38 °c) during the 72 hours prior to planned study drug application 9. participants with altered immunocompetence such as participants with ongoing cancer treatment, human immunodeficiency virus infection, organ transplant or any other active immune system disorder 10. receipt of immunoglobulin or blood products within 6 months prior to enrolment 11. receipt of a monoclonal antibody within previous 6 months or 5 half-lives, whichever is longer 12. planned surgery (excluding minor procedures such as tooth extraction or incision and drainage) during the course of the study 13. receipt of any standard vaccine within 14 days prior to day 1 14. history of alcoholism or drug addiction (as per dsm-v) within 1 year prior to screening 15. use of prescription drugs within 7 days prior to day 1 or for 5 half-lives whichever is longer, or during the study, except for hormonal contraceptives or positive result in urine drug screen or alcohol breath test at screening or day-1 16. use of over-the-counter medication within 7 days prior to day 1 or during the study; medication such as paracetamol and ibuprofen may be permitted at the discretion of the investigator and sponsor 17. receipt of immunosuppressive medications within 6 months prior to enrolment, or any active or prior history of immunodeficiency (receipt of any course of systemic corticosteroids for more than a 7-day duration and with a prednisolone equivalent dose of more than 5 mg per day within 6 months prior to enrolment will exclude a participant; inhaled or topical steroids are allowed) 18. pregnant, lactating, or planned pregnancy during the study period 19. inability to comply with the study protocol in the opinion of the investigator 20. participant has any plans to permanently relocate from the area prior to the completion of the study or to leave for an extended period of time when study visits would need to be scheduled 21. concurrent participation in another interventional clinical study investigating a vaccine, drug, medical device, or medical procedure in the 30 days preceding the study drug administration or during the course of the study 22. abnormal vital signs including systolic blood pressure (sbp) \< 90 or \> 150 mmhg, diastolic blood pressure (dbp) \< 40 or \> 90 mmhg, heart rate (hr) \< 40 or \> 100 bpm (average of triplicate measurements) at screening

1. participant with active sars-cov-2 infection, verified by rt-pcr test 2. participants tested positive for human immunodeficiency virus (hiv antibody screen), hepatitis b virus (hbsag screen) or hepatitis c virus (hcv antibody screen) 3. history of administration of any investigational or non-registered drug within 30 days or 5 half-lives, whichever is longer, prior to administration of study drug, or planned administration during the course of study participation 4. history of any reaction to monoclonal antibodies 5. history of clinically relevant atopic diseases and/or known allergies to the trial product or its components 6. history of any major pulmonary, cardiovascular, renal, neurological (e.g., cerebrovascular events), metabolic, gastrointestinal, hepato-biliary, or hematological functional abnormality, malignancy (except for adequately treated basal cell carcinoma or squamous cell carcinoma of the skin), or mental disability as per discretion of the investigator 7. any clinically significant laboratory findings at screening and enrolment and at day-1; one retest is allowed at screening and/or at day-1 8. acute illness (moderate or severe) and/or fever (body temperature ≥ 38 °c) during the 72 hours prior to planned study drug application 9. participants with altered immunocompetence such as participants with ongoing cancer treatment, human immunodeficiency virus infection, organ transplant or any other active immune system disorder 10. receipt of immunoglobulin or blood products within 6 months prior to enrolment 11. receipt of a monoclonal antibody within previous 6 months or 5 half-lives, whichever is longer 12. planned surgery (excluding minor procedures such as tooth extraction or incision and drainage) during the course of the study 13. receipt of any standard vaccine within 14 days prior to day 1 14. history of alcoholism or drug addiction (as per dsm-v) within 1 year prior to screening 15. use of prescription drugs within 7 days prior to day 1 or for 5 half-lives whichever is longer, or during the study, except for hormonal contraceptives or positive result in urine drug screen or alcohol breath test at screening or day-1 16. use of over-the-counter medication within 7 days prior to day 1 or during the study; medication such as paracetamol and ibuprofen may be permitted at the discretion of the investigator and sponsor 17. receipt of immunosuppressive medications within 6 months prior to enrolment, or any active or prior history of immunodeficiency (receipt of any course of systemic corticosteroids for more than a 7-day duration and with a prednisolone equivalent dose of more than 5 mg per day within 6 months prior to enrolment will exclude a participant; inhaled or topical steroids are allowed) 18. pregnant, lactating, or planned pregnancy during the study period 19. inability to comply with the study protocol in the opinion of the investigator 20. participant has any plans to permanently relocate from the area prior to the completion of the study or to leave for an extended period of time when study visits would need to be scheduled 21. concurrent participation in another interventional clinical study investigating a vaccine, drug, medical device, or medical procedure in the 30 days preceding the study drug administration or during the course of the study 22. abnormal vital signs including systolic blood pressure (sbp) \< 90 or \> 150 mmhg, diastolic blood pressure (dbp) \< 40 or \> 90 mmhg, heart rate (hr) \< 40 or \> 100 bpm (average of triplicate measurements) at screening

April 30, 2022, 3:30 a.m. usa

participant with active sars-cov-2 infection, verified by rt-pcr test participants tested positive for human immunodeficiency virus (hiv antibody screen), hepatitis b virus (hbsag screen) or hepatitis c virus (hcv antibody screen) history of administration of any investigational or non-registered drug within 30 days or 5 half-lives, whichever is longer, prior to administration of study drug, or planned administration during the course of study participation history of any reaction to monoclonal antibodies history of clinically relevant atopic diseases and/or known allergies to the trial product or its components history of any major pulmonary, cardiovascular, renal, neurological (e.g., cerebrovascular events), metabolic, gastrointestinal, hepato-biliary, or hematological functional abnormality, malignancy (except for adequately treated basal cell carcinoma or squamous cell carcinoma of the skin), or mental disability as per discretion of the investigator any clinically significant laboratory findings at screening and enrolment and at day-1; one retest is allowed at screening and/or at day-1 acute illness (moderate or severe) and/or fever (body temperature ≥ 38 °c) during the 72 hours prior to planned study drug application participants with altered immunocompetence such as participants with ongoing cancer treatment, human immunodeficiency virus infection, organ transplant or any other active immune system disorder receipt of immunoglobulin or blood products within 6 months prior to enrolment receipt of a monoclonal antibody within previous 6 months or 5 half-lives, whichever is longer planned surgery (excluding minor procedures such as tooth extraction or incision and drainage) during the course of the study receipt of any standard vaccine within 14 days prior to day 1 history of alcoholism or drug addiction (as per dsm-v) within 1 year prior to screening use of prescription drugs within 7 days prior to day 1 or for 5 half-lives whichever is longer, or during the study, except for hormonal contraceptives or positive result in urine drug screen or alcohol breath test at screening or day-1 use of over-the-counter medication within 7 days prior to day 1 or during the study; medication such as paracetamol and ibuprofen may be permitted at the discretion of the investigator and sponsor receipt of immunosuppressive medications within 6 months prior to enrolment, or any active or prior history of immunodeficiency (receipt of any course of systemic corticosteroids for more than a 7-day duration and with a prednisolone equivalent dose of more than 5 mg per day within 6 months prior to enrolment will exclude a participant; inhaled or topical steroids are allowed) pregnant, lactating, or planned pregnancy during the study period inability to comply with the study protocol in the opinion of the investigator participant has any plans to permanently relocate from the area prior to the completion of the study or to leave for an extended period of time when study visits would need to be scheduled concurrent participation in another interventional clinical study investigating a vaccine, drug, medical device, or medical procedure in the 30 days preceding the study drug administration or during the course of the study abnormal vital signs including systolic blood pressure (sbp) < 90 or > 150 mmhg, diastolic blood pressure (dbp) < 40 or > 90 mmhg, heart rate (hr) < 40 or > 100 bpm (average of triplicate measurements) at screening

participant with active sars-cov-2 infection, verified by rt-pcr test participants tested positive for human immunodeficiency virus (hiv antibody screen), hepatitis b virus (hbsag screen) or hepatitis c virus (hcv antibody screen) history of administration of any investigational or non-registered drug within 30 days or 5 half-lives, whichever is longer, prior to administration of study drug, or planned administration during the course of study participation history of any reaction to monoclonal antibodies history of clinically relevant atopic diseases and/or known allergies to the trial product or its components history of any major pulmonary, cardiovascular, renal, neurological (e.g., cerebrovascular events), metabolic, gastrointestinal, hepato-biliary, or hematological functional abnormality, malignancy (except for adequately treated basal cell carcinoma or squamous cell carcinoma of the skin), or mental disability as per discretion of the investigator any clinically significant laboratory findings at screening and enrolment and at day-1; one retest is allowed at screening and/or at day-1 acute illness (moderate or severe) and/or fever (body temperature ≥ 38 °c) during the 72 hours prior to planned study drug application participants with altered immunocompetence such as participants with ongoing cancer treatment, human immunodeficiency virus infection, organ transplant or any other active immune system disorder receipt of immunoglobulin or blood products within 6 months prior to enrolment receipt of a monoclonal antibody within previous 6 months or 5 half-lives, whichever is longer planned surgery (excluding minor procedures such as tooth extraction or incision and drainage) during the course of the study receipt of any standard vaccine within 14 days prior to day 1 history of alcoholism or drug addiction (as per dsm-v) within 1 year prior to screening use of prescription drugs within 7 days prior to day 1 or for 5 half-lives whichever is longer, or during the study, except for hormonal contraceptives or positive result in urine drug screen or alcohol breath test at screening or day-1 use of over-the-counter medication within 7 days prior to day 1 or during the study; medication such as paracetamol and ibuprofen may be permitted at the discretion of the investigator and sponsor receipt of immunosuppressive medications within 6 months prior to enrolment, or any active or prior history of immunodeficiency (receipt of any course of systemic corticosteroids for more than a 7-day duration and with a prednisolone equivalent dose of more than 5 mg per day within 6 months prior to enrolment will exclude a participant; inhaled or topical steroids are allowed) pregnant, lactating, or planned pregnancy during the study period inability to comply with the study protocol in the opinion of the investigator participant has any plans to permanently relocate from the area prior to the completion of the study or to leave for an extended period of time when study visits would need to be scheduled concurrent participation in another interventional clinical study investigating a vaccine, drug, medical device, or medical procedure in the 30 days preceding the study drug administration or during the course of the study abnormal vital signs including systolic blood pressure (sbp) < 90 or > 150 mmhg, diastolic blood pressure (dbp) < 40 or > 90 mmhg, heart rate (hr) < 40 or > 100 bpm (average of triplicate measurements) at screening