Created at Source Raw Value Validated value
June 22, 2022, 1:28 p.m. eu

Intervention A: acute illness with fever Prior documented infection with SARS-CoV-2 triple anticoagulation therapy Subject is currently enrolled in or has not yet completed at least 30 days since ending other investigational device or drug trial(s), or subject is receiving other investigational agent(s) Subject has known sensitivity or intolerance to any of the products to be administered for the purpose of this study Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with the study procedures Subject is pregnant or breast feeding Substudy A: SARS-CoV-2 spike protein antibodies four weeks after the 3rd vaccination > 0.8 U/mL Intervention B: Prior documented infection with SARS-CoV-2. Triple anticoagulation therapy. Subject is currently enrolled in or has not yet completed at least 30 days since ending other investigational device or drug trial(s), or subject is receiving other investigational agent(s). Subject has known sensitivity or intolerance to any of the products to be administered for the purpose of this study. Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with the study procedures. Subject is pregnant or breast feeding. Prior receipt of any mAbs against COVID19 (licensed or investigational) ≤30 days before enrolment. Administration of immunoglobulins ≤30 days before enrolment. Bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venepuncture.

Intervention A: acute illness with fever Prior documented infection with SARS-CoV-2 triple anticoagulation therapy Subject is currently enrolled in or has not yet completed at least 30 days since ending other investigational device or drug trial(s), or subject is receiving other investigational agent(s) Subject has known sensitivity or intolerance to any of the products to be administered for the purpose of this study Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with the study procedures Subject is pregnant or breast feeding Substudy A: SARS-CoV-2 spike protein antibodies four weeks after the 3rd vaccination > 0.8 U/mL Intervention B: Prior documented infection with SARS-CoV-2. Triple anticoagulation therapy. Subject is currently enrolled in or has not yet completed at least 30 days since ending other investigational device or drug trial(s), or subject is receiving other investigational agent(s). Subject has known sensitivity or intolerance to any of the products to be administered for the purpose of this study. Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with the study procedures. Subject is pregnant or breast feeding. Prior receipt of any mAbs against COVID19 (licensed or investigational) ≤30 days before enrolment. Administration of immunoglobulins ≤30 days before enrolment. Bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venepuncture.

Jan. 18, 2022, 1 a.m. eu

acute illness with fever Prior documented infection with SARS-CoV-2 triple anticoagulation therapy Subject is currently enrolled in or has not yet completed at least 30 days since ending other investigational device or drug trial(s), or subject is receiving other investigational agent(s) Subject has known sensitivity or intolerance to any of the products to be administered for the purpose of this study Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with the study procedures Subject is pregnant or breast feeding

acute illness with fever Prior documented infection with SARS-CoV-2 triple anticoagulation therapy Subject is currently enrolled in or has not yet completed at least 30 days since ending other investigational device or drug trial(s), or subject is receiving other investigational agent(s) Subject has known sensitivity or intolerance to any of the products to be administered for the purpose of this study Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with the study procedures Subject is pregnant or breast feeding

Dec. 16, 2021, 9:30 a.m. eu

acute illness with fever Prior documented infection with SARS-CoV-2 triple anticoagulation therapy Subject is currently enrolled in or has not yet completed at least 30 days since ending other investigational device or drug trial(s), or subject is receiving other investigational agent(s) Subject has known sensitivity or intolerance to any of the products to be administered for the purpose of this study Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with the study procedures Subject is pregnant or breast feeding Substudy A: SARS-CoV-2 spike protein antibodies four weeks after the 3rd vaccination > 0.8 U/mL

acute illness with fever Prior documented infection with SARS-CoV-2 triple anticoagulation therapy Subject is currently enrolled in or has not yet completed at least 30 days since ending other investigational device or drug trial(s), or subject is receiving other investigational agent(s) Subject has known sensitivity or intolerance to any of the products to be administered for the purpose of this study Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with the study procedures Subject is pregnant or breast feeding Substudy A: SARS-CoV-2 spike protein antibodies four weeks after the 3rd vaccination > 0.8 U/mL

Aug. 5, 2021, 6:30 p.m. eu

acute illness with fever Prior documented infection with SARS-CoV-2 triple anticoagulation therapy Subject is currently enrolled in or has not yet completed at least 30 days since ending other investigational device or drug trial(s), or subject is receiving other investigational agent(s) Subject has known sensitivity or intolerance to any of the products to be administered for the purpose of this study Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with the study procedures Subject is pregnant or breast feeding

acute illness with fever Prior documented infection with SARS-CoV-2 triple anticoagulation therapy Subject is currently enrolled in or has not yet completed at least 30 days since ending other investigational device or drug trial(s), or subject is receiving other investigational agent(s) Subject has known sensitivity or intolerance to any of the products to be administered for the purpose of this study Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with the study procedures Subject is pregnant or breast feeding