Created at Source Raw Value Validated value
Dec. 14, 2021, 9 a.m. eu

A subject will not be eligible for inclusion if any of the following criteria apply: Safety concerns 1. A known hypersensitivity to constituents of the IMP, including polygeline, patients with a history of allergies (severe drug allergies or severe insect bite allergy), hypersensitivities including asthma, chronic obstructive pulmonary disease (COPD), phaeochromocytomas, mastocytosis or mast cell activation disorders, patients with a history of anaphylactic/anaphylactoid reactions or existing anaphylactoid reactions and patients receiving histamine releasing agents. 2. Known history or current evidence of hypertension, diabetes mellitus, cardiovascular disease, cancer, chronic lung and acute or chronic kidney diseases. 3. Current evidence of being a smoker (defined as having smoked within 1 year prior to dosing) 4. History or current evidence of autoimmune diseases such as psoriasis, multiple sclerosis, systemic lupus erythematosus, etc 5. On treatment with interferons or other immunomodulatory/ immunosuppressive agents 6. History of anti-SARS-CoV-2 vaccination 7. Clinically relevant abnormalities in clinical chemical, hematological or any other laboratory variables on Day -1 8. Clinically relevant acute or chronic infections including HIV (exception SARS-CoV-2) 9. Moderate, Severe or Critical SARS-CoV-2 infection (see Section 6.6.2.2), including with Acute Respiratory Distress Syndrome (ARDS), treated in an intensive care unit (ICU) or on mechanical ventilation. 10. Cough and/or fever (defined as ≥38°C) 11. Blood lymphocyte count, platelet count, liver enzymes, lactate dehydrogenase (LDH) or INR outside the normal range 12. Clinically relevant elevation of serum inflammatory markers (eg, CRP, procalcitonin) 13. Subject is participating in other investigational therapy clinical trial(s) 14. Subject is lactating or breastfeeding. 15. Not able to communicate meaningfully with the Investigator and site staff. 16. Lack of ability or willingness to give informed consent. 17. Anticipated non-availability for trial visits/procedures.

A subject will not be eligible for inclusion if any of the following criteria apply: Safety concerns 1. A known hypersensitivity to constituents of the IMP, including polygeline, patients with a history of allergies (severe drug allergies or severe insect bite allergy), hypersensitivities including asthma, chronic obstructive pulmonary disease (COPD), phaeochromocytomas, mastocytosis or mast cell activation disorders, patients with a history of anaphylactic/anaphylactoid reactions or existing anaphylactoid reactions and patients receiving histamine releasing agents. 2. Known history or current evidence of hypertension, diabetes mellitus, cardiovascular disease, cancer, chronic lung and acute or chronic kidney diseases. 3. Current evidence of being a smoker (defined as having smoked within 1 year prior to dosing) 4. History or current evidence of autoimmune diseases such as psoriasis, multiple sclerosis, systemic lupus erythematosus, etc 5. On treatment with interferons or other immunomodulatory/ immunosuppressive agents 6. History of anti-SARS-CoV-2 vaccination 7. Clinically relevant abnormalities in clinical chemical, hematological or any other laboratory variables on Day -1 8. Clinically relevant acute or chronic infections including HIV (exception SARS-CoV-2) 9. Moderate, Severe or Critical SARS-CoV-2 infection (see Section 6.6.2.2), including with Acute Respiratory Distress Syndrome (ARDS), treated in an intensive care unit (ICU) or on mechanical ventilation. 10. Cough and/or fever (defined as ≥38°C) 11. Blood lymphocyte count, platelet count, liver enzymes, lactate dehydrogenase (LDH) or INR outside the normal range 12. Clinically relevant elevation of serum inflammatory markers (eg, CRP, procalcitonin) 13. Subject is participating in other investigational therapy clinical trial(s) 14. Subject is lactating or breastfeeding. 15. Not able to communicate meaningfully with the Investigator and site staff. 16. Lack of ability or willingness to give informed consent. 17. Anticipated non-availability for trial visits/procedures.

July 9, 2021, 3 p.m. eu

A subject will not be eligible for inclusion if any of the following criteria apply: Safety concerns 1. A known hypersensitivity to constituents of the IMP, including polygeline, patients with a history of allergies (severe drug allergies or severe insect bite allergy), hypersensitivities including asthma, chronic obstructive pulmonary disease (COPD), phaeochromocytomas, mastocytosis or mast cell activation disorders, patients with a history of anaphylactic/anaphylactoid reactions or existing anaphylactoid reactions and patients receiving histamine releasing agents. 2. Known history or current evidence of hypertension, diabetes mellitus, cardiovascular disease, cancer, chronic lung and acute or chronic kidney diseases. 3. Current evidence of being a smoker (defined as having smoked within 1 year prior to dosing) 4. History or current evidence of autoimmune diseases such as psoriasis, multiple sclerosis, systemic lupus erythematosus, etc 5. On treatment with interferons or other immunomodulatory/ immunosuppressive agents 6. History of anti-SARS-CoV-2 vaccination 7. Clinically relevant abnormalities in clinical chemical, hematological or any other laboratory variables on Day -1 8. Clinically relevant acute or chronic infections including HIV (exception SARS-CoV-2) 9. Moderate, Severe or Critical SARS-CoV-2 infection (see Section 6.6.2.2), including with Acute Respiratory Distress Syndrome (ARDS), treated in an intensive care unit (ICU) or on mechanical ventilation. 10. Cough and/or fever (defined as ≥38°C) 11. Blood lymphocyte count, platelet count, liver enzymes, lactate dehydrogenase (LDH) or INR outside the normal range 12. Clinically relevant elevation of serum inflammatory markers (eg, CRP, procalcitonin) 13. Subject is participating in other investigational therapy clinical trial(s) 14. Subject is lactating or breastfeeding. 15. Not able to communicate meaningfully with the Investigator and site staff. 16. Lack of ability or willingness to give informed consent. 17. Anticipated non-availability for trial visits/procedures. 18. Vulnerable subjects (eg, persons kept in detention or persons who have a dependent relationship to the Sponsor or Investigator).

A subject will not be eligible for inclusion if any of the following criteria apply: Safety concerns 1. A known hypersensitivity to constituents of the IMP, including polygeline, patients with a history of allergies (severe drug allergies or severe insect bite allergy), hypersensitivities including asthma, chronic obstructive pulmonary disease (COPD), phaeochromocytomas, mastocytosis or mast cell activation disorders, patients with a history of anaphylactic/anaphylactoid reactions or existing anaphylactoid reactions and patients receiving histamine releasing agents. 2. Known history or current evidence of hypertension, diabetes mellitus, cardiovascular disease, cancer, chronic lung and acute or chronic kidney diseases. 3. Current evidence of being a smoker (defined as having smoked within 1 year prior to dosing) 4. History or current evidence of autoimmune diseases such as psoriasis, multiple sclerosis, systemic lupus erythematosus, etc 5. On treatment with interferons or other immunomodulatory/ immunosuppressive agents 6. History of anti-SARS-CoV-2 vaccination 7. Clinically relevant abnormalities in clinical chemical, hematological or any other laboratory variables on Day -1 8. Clinically relevant acute or chronic infections including HIV (exception SARS-CoV-2) 9. Moderate, Severe or Critical SARS-CoV-2 infection (see Section 6.6.2.2), including with Acute Respiratory Distress Syndrome (ARDS), treated in an intensive care unit (ICU) or on mechanical ventilation. 10. Cough and/or fever (defined as ≥38°C) 11. Blood lymphocyte count, platelet count, liver enzymes, lactate dehydrogenase (LDH) or INR outside the normal range 12. Clinically relevant elevation of serum inflammatory markers (eg, CRP, procalcitonin) 13. Subject is participating in other investigational therapy clinical trial(s) 14. Subject is lactating or breastfeeding. 15. Not able to communicate meaningfully with the Investigator and site staff. 16. Lack of ability or willingness to give informed consent. 17. Anticipated non-availability for trial visits/procedures. 18. Vulnerable subjects (eg, persons kept in detention or persons who have a dependent relationship to the Sponsor or Investigator).

July 7, 2021, 12:30 p.m. eu

A subject will not be eligible for inclusion if any of the following criteria apply: Safety concerns 1. A known hypersensitivity to constituents of the IMP, including polygeline, patients with a history of allergies (severe drug allergies or severe insect bite allergy), hypersensitivities including asthma, chronic obstructive pulmonary disease (COPD), phaeochromocytomas, mastocytosis or mast cell activation disorders, patients with a history of anaphylactic/anaphylactoid reactions or existing anaphylactoid reactions and patients receiving histamine releasing agents. 2. Known history or current evidence of hypertension, diabetes mellitus, cardiovascular disease, cancer, chronic lung and acute or chronic kidney diseases. 3. Current evidence of being a smoker (defined as having smoked within 1 year prior to dosing) 4. History or current evidence of autoimmune diseases such as psoriasis, multiple sclerosis, systemic lupus erythematosus, etc 5. On treatment with interferons or other immunomodulatory/ immunosuppressive agents 6. History of anti-SARS-CoV-2 vaccination 7. Clinically relevant abnormalities in clinical chemical, hematological or any other laboratory variables on Day -1 8. Clinically relevant acute or chronic infections including HIV (exception SARS-CoV-2) 9. Moderate, Severe or Critical SARS-CoV-2 infection (see Section 6.6.2.2), including with Acute Respiratory Distress Syndrome (ARDS), treated in an intensive care unit (ICU) or on mechanical ventilation. 10. Cough and/or fever (defined as ≥38°C) 11. Blood lymphocyte count, platelet count, liver enzymes, lactate dehydrogenase (LDH) or INR outside the normal range 12. Clinically relevant elevation of serum inflammatory markers (eg, CRP, procalcitonin) 13. Subject is participating in other investigational therapy clinical trial(s) 14. Subject is lactating or breastfeeding. 15. Not able to communicate meaningfully with the Investigator and site staff. 16. Lack of ability or willingness to give informed consent. 17. Anticipated non-availability for trial visits/procedures.

A subject will not be eligible for inclusion if any of the following criteria apply: Safety concerns 1. A known hypersensitivity to constituents of the IMP, including polygeline, patients with a history of allergies (severe drug allergies or severe insect bite allergy), hypersensitivities including asthma, chronic obstructive pulmonary disease (COPD), phaeochromocytomas, mastocytosis or mast cell activation disorders, patients with a history of anaphylactic/anaphylactoid reactions or existing anaphylactoid reactions and patients receiving histamine releasing agents. 2. Known history or current evidence of hypertension, diabetes mellitus, cardiovascular disease, cancer, chronic lung and acute or chronic kidney diseases. 3. Current evidence of being a smoker (defined as having smoked within 1 year prior to dosing) 4. History or current evidence of autoimmune diseases such as psoriasis, multiple sclerosis, systemic lupus erythematosus, etc 5. On treatment with interferons or other immunomodulatory/ immunosuppressive agents 6. History of anti-SARS-CoV-2 vaccination 7. Clinically relevant abnormalities in clinical chemical, hematological or any other laboratory variables on Day -1 8. Clinically relevant acute or chronic infections including HIV (exception SARS-CoV-2) 9. Moderate, Severe or Critical SARS-CoV-2 infection (see Section 6.6.2.2), including with Acute Respiratory Distress Syndrome (ARDS), treated in an intensive care unit (ICU) or on mechanical ventilation. 10. Cough and/or fever (defined as ≥38°C) 11. Blood lymphocyte count, platelet count, liver enzymes, lactate dehydrogenase (LDH) or INR outside the normal range 12. Clinically relevant elevation of serum inflammatory markers (eg, CRP, procalcitonin) 13. Subject is participating in other investigational therapy clinical trial(s) 14. Subject is lactating or breastfeeding. 15. Not able to communicate meaningfully with the Investigator and site staff. 16. Lack of ability or willingness to give informed consent. 17. Anticipated non-availability for trial visits/procedures.