Created at Source Raw Value Validated value
Aug. 5, 2021, 3:30 p.m. oms

Current exclusion criteria as of 29/07/2021: 1. Other clinically significant and uncontrolled pathologies that may interfere with study results (e.g. rheumatic diseases) 2. Presence of any relevant organic, systemic or metabolic disease (particularly significant history of cardiac, renal, neurological, psychiatric, oncology, endocrinology, metabolic or hepatic disease), or abnormal laboratory values that will be deemed clinically significant based on predefined values 3. Immune system illnesses 4. Known drug and/or alcohol abuse 5. Individuals who are cognitively impaired and/or who are unable to give informed consent 6. Ongoing or prior participation in any other clinical trial of an experimental treatment for COVID-19 7. Ongoing or prior participation in any other clinical trial of an experimental treatment within 30 days from enrollment day 8. Intubated or prior intubation (during present hospitalization) or anticipated intubation within the subsequent 2 h 9. Using high-flow nasal cannula (HFNC) or non-invasive ventilation (NIV) 10. Concurrent or planned treatment with other agents with actual or possible direct antiviral activity 11. Prior hospitalization for COVID-19 12. Positive pregnancy test or breastfeeding woman 13. Known hypersensitivity to the study treatment, its metabolites, or formulation excipient 14. History of severe drug and/or food allergies and/or known allergies to the trial product or its components 15. Any condition that, in the opinion of the Investigator, would complicate or compromise the study or well-being of the patient Previous exclusion criteria: 1. Other clinically significant and uncontrolled pathologies that may interfere with study results (e.g. rheumatic diseases) 2. Presence of any relevant organic, systemic or metabolic disease (particularly significant history of cardiac, renal, neurological, psychiatric, oncology, endocrinology, metabolic or hepatic disease), or abnormal laboratory values that will be deemed clinically significant based on predefined values 3. Immune system illnesses 4. Known drug and/or alcohol abuse 5. Individuals who are cognitively impaired and/or who are unable to give informed consent 6. Ongoing or prior participation in any other clinical trial of an experimental treatment for COVID-19 (including COVID-19 vaccine) 7. Vaccination with COVID-19 vaccine 8. Ongoing or prior participation in any other clinical trial of an experimental treatment within 30 days from enrollment day 9. Intubated or prior intubation (during present hospitalization) or anticipated intubation within the subsequent 2 h 10. Using high-flow nasal cannula (HFNC) or non-invasive ventilation (NIV) 11. Concurrent or planned treatment with other agents with actual or possible direct antiviral activity 12. Prior hospitalization for COVID-19 13. Positive pregnancy test or breastfeeding woman 14. Known hypersensitivity to the study treatment, its metabolites, or formulation excipient 15. History of severe dr

Current exclusion criteria as of 29/07/2021: 1. Other clinically significant and uncontrolled pathologies that may interfere with study results (e.g. rheumatic diseases) 2. Presence of any relevant organic, systemic or metabolic disease (particularly significant history of cardiac, renal, neurological, psychiatric, oncology, endocrinology, metabolic or hepatic disease), or abnormal laboratory values that will be deemed clinically significant based on predefined values 3. Immune system illnesses 4. Known drug and/or alcohol abuse 5. Individuals who are cognitively impaired and/or who are unable to give informed consent 6. Ongoing or prior participation in any other clinical trial of an experimental treatment for COVID-19 7. Ongoing or prior participation in any other clinical trial of an experimental treatment within 30 days from enrollment day 8. Intubated or prior intubation (during present hospitalization) or anticipated intubation within the subsequent 2 h 9. Using high-flow nasal cannula (HFNC) or non-invasive ventilation (NIV) 10. Concurrent or planned treatment with other agents with actual or possible direct antiviral activity 11. Prior hospitalization for COVID-19 12. Positive pregnancy test or breastfeeding woman 13. Known hypersensitivity to the study treatment, its metabolites, or formulation excipient 14. History of severe drug and/or food allergies and/or known allergies to the trial product or its components 15. Any condition that, in the opinion of the Investigator, would complicate or compromise the study or well-being of the patient Previous exclusion criteria: 1. Other clinically significant and uncontrolled pathologies that may interfere with study results (e.g. rheumatic diseases) 2. Presence of any relevant organic, systemic or metabolic disease (particularly significant history of cardiac, renal, neurological, psychiatric, oncology, endocrinology, metabolic or hepatic disease), or abnormal laboratory values that will be deemed clinically significant based on predefined values 3. Immune system illnesses 4. Known drug and/or alcohol abuse 5. Individuals who are cognitively impaired and/or who are unable to give informed consent 6. Ongoing or prior participation in any other clinical trial of an experimental treatment for COVID-19 (including COVID-19 vaccine) 7. Vaccination with COVID-19 vaccine 8. Ongoing or prior participation in any other clinical trial of an experimental treatment within 30 days from enrollment day 9. Intubated or prior intubation (during present hospitalization) or anticipated intubation within the subsequent 2 h 10. Using high-flow nasal cannula (HFNC) or non-invasive ventilation (NIV) 11. Concurrent or planned treatment with other agents with actual or possible direct antiviral activity 12. Prior hospitalization for COVID-19 13. Positive pregnancy test or breastfeeding woman 14. Known hypersensitivity to the study treatment, its metabolites, or formulation excipient 15. History of severe dr

May 20, 2021, 7:59 a.m. oms

1. Other clinically significant and uncontrolled pathologies that may interfere with study results (e.g. rheumatic diseases) 2. Presence of any relevant organic, systemic or metabolic disease (particularly significant history of cardiac, renal, neurological, psychiatric, oncology, endocrinology, metabolic or hepatic disease), or abnormal laboratory values that will be deemed clinically significant based on predefined values 3. Immune system illnesses 4. Known drug and/or alcohol abuse 5. Individuals who are cognitively impaired and/or who are unable to give informed consent 6. Ongoing or prior participation in any other clinical trial of an experimental treatment for COVID-19 (including COVID-19 vaccine) 7. Vaccination with COVID-19 vaccine 8. Ongoing or prior participation in any other clinical trial of an experimental treatment within 30 days from enrollment day 9. Intubated or prior intubation (during present hospitalization) or anticipated intubation within the subsequent 2 h 10. Using high-flow nasal cannula (HFNC) or non-invasive ventilation (NIV) 11. Concurrent or planned treatment with other agents with actual or possible direct antiviral activity 12. Prior hospitalization for COVID-19 13. Positive pregnancy test or breastfeeding woman 14. Known hypersensitivity to the study treatment, its metabolites, or formulation excipient 15. History of severe drug and/or food allergies and/or known allergies to the trial product or its components 16. Any condition that, in the opinion of the Investigator, would complicate or compromise the study or well-being of the patient

1. Other clinically significant and uncontrolled pathologies that may interfere with study results (e.g. rheumatic diseases) 2. Presence of any relevant organic, systemic or metabolic disease (particularly significant history of cardiac, renal, neurological, psychiatric, oncology, endocrinology, metabolic or hepatic disease), or abnormal laboratory values that will be deemed clinically significant based on predefined values 3. Immune system illnesses 4. Known drug and/or alcohol abuse 5. Individuals who are cognitively impaired and/or who are unable to give informed consent 6. Ongoing or prior participation in any other clinical trial of an experimental treatment for COVID-19 (including COVID-19 vaccine) 7. Vaccination with COVID-19 vaccine 8. Ongoing or prior participation in any other clinical trial of an experimental treatment within 30 days from enrollment day 9. Intubated or prior intubation (during present hospitalization) or anticipated intubation within the subsequent 2 h 10. Using high-flow nasal cannula (HFNC) or non-invasive ventilation (NIV) 11. Concurrent or planned treatment with other agents with actual or possible direct antiviral activity 12. Prior hospitalization for COVID-19 13. Positive pregnancy test or breastfeeding woman 14. Known hypersensitivity to the study treatment, its metabolites, or formulation excipient 15. History of severe drug and/or food allergies and/or known allergies to the trial product or its components 16. Any condition that, in the opinion of the Investigator, would complicate or compromise the study or well-being of the patient