Created at Source Raw Value Validated value
April 21, 2022, 7:30 p.m. oms

1. Prior intervention for SARS-CoV-2 prophylaxis within 4 months of Day 1. 2. Prior treatment with a SARS-CoV-2 specific monoclonal antibody or convalescent COVID-19 plasma within 4 months of Day 1. 3. Significant pericardial effusions, pleural effusions or ascites. 4. Subject has experienced a history of coronary artery disease, with or without angina pectoris or myocardial infarction, symptomatic congestive heart failure (New York Heart Association > Class II), uncontrolled hypertension (systolic > 160 mmHg or diastolic > 100 mmHg), or cardiac arrhythmias requiring anti-arrhythmic therapy. 5. History of uncontrolled arterial or venous thrombosis. Subjects with a history of arterial or venous thrombosis are eligible if the subject is controlled via ongoing therapeutic intervention. 6. Active or uncontrolled severe infection. 7. Received the following procedures within 28 days prior to receiving their first dose (Day 1), (or has not recovered from the toxic effects of such therapy) including: • radiotherapy • major surgery. 8. History of myocarditis. 9. QTc interval prolonging medicines should be reviewed and where possible their use should be minimized and alternate medicines that are not QTc interval prolonging considered as substitutes. 10. Known allergy/hypersensitivity to investigational components or excipients (monoclonal antibody infusions, interferon therapy or bacterial vaccines). 11. Any kind of disorder that, in the opinion of the Investigator, may compromise the ability of the subject to give written informed consent and/or to comply with all required study procedures. 12. History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the Investigator would pose a risk to subject safety or interfere with the study evaluation, procedures or completion. 13. Platelet disorder or other bleeding disorder that may cause contraindication to injection. 14. Prior administration of other investigational agents less than or equal to 15 days prior to study Day 1. 15. Prior administration of attenuated vaccine in last 30 days. 16. Prior administration of inactivated vaccine in last 14 days.

1. Prior intervention for SARS-CoV-2 prophylaxis within 4 months of Day 1. 2. Prior treatment with a SARS-CoV-2 specific monoclonal antibody or convalescent COVID-19 plasma within 4 months of Day 1. 3. Significant pericardial effusions, pleural effusions or ascites. 4. Subject has experienced a history of coronary artery disease, with or without angina pectoris or myocardial infarction, symptomatic congestive heart failure (New York Heart Association > Class II), uncontrolled hypertension (systolic > 160 mmHg or diastolic > 100 mmHg), or cardiac arrhythmias requiring anti-arrhythmic therapy. 5. History of uncontrolled arterial or venous thrombosis. Subjects with a history of arterial or venous thrombosis are eligible if the subject is controlled via ongoing therapeutic intervention. 6. Active or uncontrolled severe infection. 7. Received the following procedures within 28 days prior to receiving their first dose (Day 1), (or has not recovered from the toxic effects of such therapy) including: • radiotherapy • major surgery. 8. History of myocarditis. 9. QTc interval prolonging medicines should be reviewed and where possible their use should be minimized and alternate medicines that are not QTc interval prolonging considered as substitutes. 10. Known allergy/hypersensitivity to investigational components or excipients (monoclonal antibody infusions, interferon therapy or bacterial vaccines). 11. Any kind of disorder that, in the opinion of the Investigator, may compromise the ability of the subject to give written informed consent and/or to comply with all required study procedures. 12. History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the Investigator would pose a risk to subject safety or interfere with the study evaluation, procedures or completion. 13. Platelet disorder or other bleeding disorder that may cause contraindication to injection. 14. Prior administration of other investigational agents less than or equal to 15 days prior to study Day 1. 15. Prior administration of attenuated vaccine in last 30 days. 16. Prior administration of inactivated vaccine in last 14 days.

Dec. 22, 2021, 4:30 p.m. oms

1. Prior intervention for SARS-CoV-2 prophylaxis within 6 months of Day 1. 2. Prior treatment with a SARS-CoV-2 specific monoclonal antibody or convalescent COVID-19 plasma within 6 months of Day 1. 3. Significant pericardial effusions, pleural effusions or ascites. 4. Subject has experienced a history of coronary artery disease, with or without angina pectoris or myocardial infarction, symptomatic congestive heart failure (New York Heart Association > Class II), uncontrolled hypertension (systolic > 160 mmHg or diastolic > 100 mmHg), or cardiac arrhythmias requiring anti-arrhythmic therapy. 5. History of uncontrolled arterial or venous thrombosis. Subjects with a history of arterial or venous thrombosis are eligible if the subject is controlled via ongoing therapeutic intervention. 6. Active or uncontrolled severe infection. 7. Received the following procedures within 28 days prior to receiving their first dose (Day 1), (or has not recovered from the toxic effects of such therapy) including: • radiotherapy • major surgery. 8. History of myocarditis. 9. QTc interval prolonging medicines should be reviewed and where possible their use should be minimized and alternate medicines that are not QTc interval prolonging considered as substitutes. 10. Known allergy/hypersensitivity to investigational components or excipients (monoclonal antibody infusions, interferon therapy or bacterial vaccines). 11. Any kind of disorder that, in the opinion of the Investigator, may compromise the ability of the subject to give written informed consent and/or to comply with all required study procedures. 12. History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the Investigator would pose a risk to subject safety or interfere with the study evaluation, procedures or completion. 13. Platelet disorder or other bleeding disorder that may cause contraindication to injection. 14. Prior administration of other investigational agents =15 days prior to study Day 1. 15. Prior administration of attenuated vaccine in last 30 days. 16. Prior administration of inactivated vaccine in last 14 days.

1. Prior intervention for SARS-CoV-2 prophylaxis within 6 months of Day 1. 2. Prior treatment with a SARS-CoV-2 specific monoclonal antibody or convalescent COVID-19 plasma within 6 months of Day 1. 3. Significant pericardial effusions, pleural effusions or ascites. 4. Subject has experienced a history of coronary artery disease, with or without angina pectoris or myocardial infarction, symptomatic congestive heart failure (New York Heart Association > Class II), uncontrolled hypertension (systolic > 160 mmHg or diastolic > 100 mmHg), or cardiac arrhythmias requiring anti-arrhythmic therapy. 5. History of uncontrolled arterial or venous thrombosis. Subjects with a history of arterial or venous thrombosis are eligible if the subject is controlled via ongoing therapeutic intervention. 6. Active or uncontrolled severe infection. 7. Received the following procedures within 28 days prior to receiving their first dose (Day 1), (or has not recovered from the toxic effects of such therapy) including: • radiotherapy • major surgery. 8. History of myocarditis. 9. QTc interval prolonging medicines should be reviewed and where possible their use should be minimized and alternate medicines that are not QTc interval prolonging considered as substitutes. 10. Known allergy/hypersensitivity to investigational components or excipients (monoclonal antibody infusions, interferon therapy or bacterial vaccines). 11. Any kind of disorder that, in the opinion of the Investigator, may compromise the ability of the subject to give written informed consent and/or to comply with all required study procedures. 12. History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the Investigator would pose a risk to subject safety or interfere with the study evaluation, procedures or completion. 13. Platelet disorder or other bleeding disorder that may cause contraindication to injection. 14. Prior administration of other investigational agents =15 days prior to study Day 1. 15. Prior administration of attenuated vaccine in last 30 days. 16. Prior administration of inactivated vaccine in last 14 days.

Sept. 1, 2021, 11 p.m. oms

1. History of a positive SARS-CoV-2 serology test. 2. Prior intervention for SARS-CoV-2 prophylaxis. 3. Prior treatment with a SARS-CoV-2 specific monoclonal antibody or convalescent COVID-19 plasma. 4. Significant pericardial effusions, pleural effusions or ascites. 5. Subject has experienced a history of coronary artery disease, with or without angina pectoris or myocardial infarction, symptomatic congestive heart failure (New York Heart Association > Class II), uncontrolled hypertension (systolic > 160 mmHg or diastolic > 100 mmHg), or cardiac arrhythmias requiring anti-arrhythmic therapy. 6. History of uncontrolled arterial or venous thrombosis. Subjects with a history of arterial or venous thrombosis are eligible if the subject is controlled on low dose molecular weight heparins or low dose aspirin. 7. Active or uncontrolled severe infection. 8. Received the following procedures within 28 days prior to receiving their first dose (Day 1), (or has not recovered from the toxic effects of such therapy) including: • radiotherapy • major surgery. 9. Prior other therapies or procedures prior to receiving their first dose: • Anticoagulation therapy (within 7 days of Study Day 1), except low molecular weight heparins or low dose aspirin. 10. QTc interval prolonging medicines should be reviewed and where possible their use should be minimized and alternate medicines that are not QTc interval prolonging considered as substitutes. 11. Known allergy/hypersensitivity to investigational components or excipients (monoclonal antibody infusions, interferon therapy or bacterial vaccines). 12. Any kind of disorder that, in the opinion of the Investigator, may compromise the ability of the subject to give written informed consent and/or to comply with all required study procedures. 13. History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the Investigator would pose a risk to subject safety or interfere with the study evaluation, procedures or completion. 14. Platelet disorder or other bleeding disorder that may cause contraindication to injection. 15. Prior administration of other investigational agents within 15 days prior to study Day 1. 16. Prior administration of attenuated vaccine within the last 30 days. 17. Prior administration of inactivated vaccine within the last 14 days.

1. History of a positive SARS-CoV-2 serology test. 2. Prior intervention for SARS-CoV-2 prophylaxis. 3. Prior treatment with a SARS-CoV-2 specific monoclonal antibody or convalescent COVID-19 plasma. 4. Significant pericardial effusions, pleural effusions or ascites. 5. Subject has experienced a history of coronary artery disease, with or without angina pectoris or myocardial infarction, symptomatic congestive heart failure (New York Heart Association > Class II), uncontrolled hypertension (systolic > 160 mmHg or diastolic > 100 mmHg), or cardiac arrhythmias requiring anti-arrhythmic therapy. 6. History of uncontrolled arterial or venous thrombosis. Subjects with a history of arterial or venous thrombosis are eligible if the subject is controlled on low dose molecular weight heparins or low dose aspirin. 7. Active or uncontrolled severe infection. 8. Received the following procedures within 28 days prior to receiving their first dose (Day 1), (or has not recovered from the toxic effects of such therapy) including: • radiotherapy • major surgery. 9. Prior other therapies or procedures prior to receiving their first dose: • Anticoagulation therapy (within 7 days of Study Day 1), except low molecular weight heparins or low dose aspirin. 10. QTc interval prolonging medicines should be reviewed and where possible their use should be minimized and alternate medicines that are not QTc interval prolonging considered as substitutes. 11. Known allergy/hypersensitivity to investigational components or excipients (monoclonal antibody infusions, interferon therapy or bacterial vaccines). 12. Any kind of disorder that, in the opinion of the Investigator, may compromise the ability of the subject to give written informed consent and/or to comply with all required study procedures. 13. History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the Investigator would pose a risk to subject safety or interfere with the study evaluation, procedures or completion. 14. Platelet disorder or other bleeding disorder that may cause contraindication to injection. 15. Prior administration of other investigational agents within 15 days prior to study Day 1. 16. Prior administration of attenuated vaccine within the last 30 days. 17. Prior administration of inactivated vaccine within the last 14 days.