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

1. hospitalized for more than 48 hours. 2. fbg levels ≥ 200 mg/dl 3. known or suspected allergy to any of the ingredients in the investigational product or standardized meals. 4. currently undergoing invasive mechanical ventilation (including venous ecmo) at the time of screening. (who category 6 and 7). 5. alt/ast \> 2.5 times the upper limit of normal or a history of decompensated cirrhosis. 6. serum creatinine \> 2 times the upper limit of normal. 7. patients currently on monoclonal antibodies including antibody cocktails. 8. patients for whom, in the opinion of the investigator, progression to death is imminent and inevitable within the next 48 - 72 hours, irrespective of the provision of treatment. 9. patients for whom, in the opinion of the investigator, progression to mechanical ventilation is imminent and inevitable within the next 24 hours, irrespective of the provision of treatment. 10. possibility of the patient being discharged from hospital within 24 hours. 11. participation in other anti-covid-19 interventional trials. 12. other known active infections or other clinical conditions (e.g., chronic obstructive pulmonary disease) that contraindicate aerosolized inhalation; coexisting pneumonia is allowed. 13. patients with known instance of angina or myocardial infarction prior to 3 months of screening visit. 14. patients with current or prior psychiatric illness, seizure disorders, autoimmune disorders, pre-existing severe cardiovascular disease and patients with prior transplants. 15. females who are breast-feeding, lactating, pregnant or intending to become pregnant. 16. diagnosed for hepatitis b, hepatitis c or uncontrolled hiv. 17. presenting, in the opinion of the investigator, a clinically significant abnormality with regard to the clinical examination and/or clinical chemistry screening parameters. 18. history of cancer in the last 5 years, or currently has cancer, as assessed by investigator. 19. has a history of, or current neurological (neurodegenerative diseases, epilepsy) or psychiatric pathology that may impact the participant's ability to comply with the requirements of the protocol, as assessed by investigator. 20. frequent consumption of alcohol (\> 2 standard servings of alcohol/day on average). 21. history of (assessed by pi) or current tobacco use. 22. patients with history of drug abuse (amphetamines, cannabinoids, cocaine and opiates) 23. inability to provide blood and/or urine samples. 24. any condition that could, in the opinion of the investigator, preclude the participant's ability to successfully and safely complete the study or that may confound study outcomes.

1. hospitalized for more than 48 hours. 2. fbg levels ≥ 200 mg/dl 3. known or suspected allergy to any of the ingredients in the investigational product or standardized meals. 4. currently undergoing invasive mechanical ventilation (including venous ecmo) at the time of screening. (who category 6 and 7). 5. alt/ast \> 2.5 times the upper limit of normal or a history of decompensated cirrhosis. 6. serum creatinine \> 2 times the upper limit of normal. 7. patients currently on monoclonal antibodies including antibody cocktails. 8. patients for whom, in the opinion of the investigator, progression to death is imminent and inevitable within the next 48 - 72 hours, irrespective of the provision of treatment. 9. patients for whom, in the opinion of the investigator, progression to mechanical ventilation is imminent and inevitable within the next 24 hours, irrespective of the provision of treatment. 10. possibility of the patient being discharged from hospital within 24 hours. 11. participation in other anti-covid-19 interventional trials. 12. other known active infections or other clinical conditions (e.g., chronic obstructive pulmonary disease) that contraindicate aerosolized inhalation; coexisting pneumonia is allowed. 13. patients with known instance of angina or myocardial infarction prior to 3 months of screening visit. 14. patients with current or prior psychiatric illness, seizure disorders, autoimmune disorders, pre-existing severe cardiovascular disease and patients with prior transplants. 15. females who are breast-feeding, lactating, pregnant or intending to become pregnant. 16. diagnosed for hepatitis b, hepatitis c or uncontrolled hiv. 17. presenting, in the opinion of the investigator, a clinically significant abnormality with regard to the clinical examination and/or clinical chemistry screening parameters. 18. history of cancer in the last 5 years, or currently has cancer, as assessed by investigator. 19. has a history of, or current neurological (neurodegenerative diseases, epilepsy) or psychiatric pathology that may impact the participant's ability to comply with the requirements of the protocol, as assessed by investigator. 20. frequent consumption of alcohol (\> 2 standard servings of alcohol/day on average). 21. history of (assessed by pi) or current tobacco use. 22. patients with history of drug abuse (amphetamines, cannabinoids, cocaine and opiates) 23. inability to provide blood and/or urine samples. 24. any condition that could, in the opinion of the investigator, preclude the participant's ability to successfully and safely complete the study or that may confound study outcomes.

Feb. 2, 2022, 1 p.m. usa

hospitalized for more than 48 hours. fbg levels ≥ 200 mg/dl known or suspected allergy to any of the ingredients in the investigational product or standardized meals. currently undergoing invasive mechanical ventilation (including venous ecmo) at the time of screening. (who category 6 and 7). alt/ast > 2.5 times the upper limit of normal or a history of decompensated cirrhosis. serum creatinine > 2 times the upper limit of normal. patients currently on monoclonal antibodies including antibody cocktails. patients for whom, in the opinion of the investigator, progression to death is imminent and inevitable within the next 48 - 72 hours, irrespective of the provision of treatment. patients for whom, in the opinion of the investigator, progression to mechanical ventilation is imminent and inevitable within the next 24 hours, irrespective of the provision of treatment. possibility of the patient being discharged from hospital within 24 hours. participation in other anti-covid-19 interventional trials. other known active infections or other clinical conditions (e.g., chronic obstructive pulmonary disease) that contraindicate aerosolized inhalation; coexisting pneumonia is allowed. patients with known instance of angina or myocardial infarction prior to 3 months of screening visit. patients with current or prior psychiatric illness, seizure disorders, autoimmune disorders, pre-existing severe cardiovascular disease and patients with prior transplants. females who are breast-feeding, lactating, pregnant or intending to become pregnant. diagnosed for hepatitis b, hepatitis c or uncontrolled hiv. presenting, in the opinion of the investigator, a clinically significant abnormality with regard to the clinical examination and/or clinical chemistry screening parameters. history of cancer in the last 5 years, or currently has cancer, as assessed by investigator. has a history of, or current neurological (neurodegenerative diseases, epilepsy) or psychiatric pathology that may impact the participant's ability to comply with the requirements of the protocol, as assessed by investigator. frequent consumption of alcohol (> 2 standard servings of alcohol/day on average). history of (assessed by pi) or current tobacco use. patients with history of drug abuse (amphetamines, cannabinoids, cocaine and opiates) inability to provide blood and/or urine samples. any condition that could, in the opinion of the investigator, preclude the participant's ability to successfully and safely complete the study or that may confound study outcomes.

hospitalized for more than 48 hours. fbg levels ≥ 200 mg/dl known or suspected allergy to any of the ingredients in the investigational product or standardized meals. currently undergoing invasive mechanical ventilation (including venous ecmo) at the time of screening. (who category 6 and 7). alt/ast > 2.5 times the upper limit of normal or a history of decompensated cirrhosis. serum creatinine > 2 times the upper limit of normal. patients currently on monoclonal antibodies including antibody cocktails. patients for whom, in the opinion of the investigator, progression to death is imminent and inevitable within the next 48 - 72 hours, irrespective of the provision of treatment. patients for whom, in the opinion of the investigator, progression to mechanical ventilation is imminent and inevitable within the next 24 hours, irrespective of the provision of treatment. possibility of the patient being discharged from hospital within 24 hours. participation in other anti-covid-19 interventional trials. other known active infections or other clinical conditions (e.g., chronic obstructive pulmonary disease) that contraindicate aerosolized inhalation; coexisting pneumonia is allowed. patients with known instance of angina or myocardial infarction prior to 3 months of screening visit. patients with current or prior psychiatric illness, seizure disorders, autoimmune disorders, pre-existing severe cardiovascular disease and patients with prior transplants. females who are breast-feeding, lactating, pregnant or intending to become pregnant. diagnosed for hepatitis b, hepatitis c or uncontrolled hiv. presenting, in the opinion of the investigator, a clinically significant abnormality with regard to the clinical examination and/or clinical chemistry screening parameters. history of cancer in the last 5 years, or currently has cancer, as assessed by investigator. has a history of, or current neurological (neurodegenerative diseases, epilepsy) or psychiatric pathology that may impact the participant's ability to comply with the requirements of the protocol, as assessed by investigator. frequent consumption of alcohol (> 2 standard servings of alcohol/day on average). history of (assessed by pi) or current tobacco use. patients with history of drug abuse (amphetamines, cannabinoids, cocaine and opiates) inability to provide blood and/or urine samples. any condition that could, in the opinion of the investigator, preclude the participant's ability to successfully and safely complete the study or that may confound study outcomes.

Jan. 5, 2022, 7 a.m. usa

hospitalized for more than 48 hours. fbg levels ≥ 200 mg/dl known or suspected allergy to any of the ingredients in the investigational product or standardized meals. currently undergoing invasive mechanical ventilation (including venous ecmo) at the time of screening. (who category 6 and 7). alt/ast > 2.5 times the upper limit of normal or a history of decompensated cirrhosis. serum creatinine > 2 times the upper limit of normal. patients currently on monoclonal antibodies including antibody cocktails. patients for whom, in the opinion of the investigator, progression to death is imminent and inevitable within the next 48 - 72 hours, irrespective of the provision of treatment. patients for whom, in the opinion of the investigator, progression to mechanical ventilation is imminent and inevitable within the next 24 hours, irrespective of the provision of treatment. possibility of the patient being discharged from the hospital within 24 hours. participation in other anti-covid-19 interventional trials. females who are breastfeeding, lactating, pregnant or intending to become pregnant. frequent consumption of alcohol (> 2 standard servings of alcohol/day on average). history of (assessed by pi) or current tobacco use. inability to provide blood and/or urine samples.

hospitalized for more than 48 hours. fbg levels ≥ 200 mg/dl known or suspected allergy to any of the ingredients in the investigational product or standardized meals. currently undergoing invasive mechanical ventilation (including venous ecmo) at the time of screening. (who category 6 and 7). alt/ast > 2.5 times the upper limit of normal or a history of decompensated cirrhosis. serum creatinine > 2 times the upper limit of normal. patients currently on monoclonal antibodies including antibody cocktails. patients for whom, in the opinion of the investigator, progression to death is imminent and inevitable within the next 48 - 72 hours, irrespective of the provision of treatment. patients for whom, in the opinion of the investigator, progression to mechanical ventilation is imminent and inevitable within the next 24 hours, irrespective of the provision of treatment. possibility of the patient being discharged from the hospital within 24 hours. participation in other anti-covid-19 interventional trials. females who are breastfeeding, lactating, pregnant or intending to become pregnant. frequent consumption of alcohol (> 2 standard servings of alcohol/day on average). history of (assessed by pi) or current tobacco use. inability to provide blood and/or urine samples.