Created at Source Raw Value Validated value
April 8, 2022, 3:30 p.m. oms

1. Hospitalized for more than 48 hours. <br/ >2. FBG levels â?¥ 200 mg/dL <br/ >3. Known or suspected allergy to any of the ingredients in the investigational product or standardized meals. <br/ >4. Currently undergoing invasive mechanical ventilation (including venous ECMO) at the time of screening. (WHO category 6 and 7). <br/ >5. ALT/AST > 2.5 times the upper limit of normal or a history of decompensated cirrhosis. <br/ >6. Serum creatinine > 2 times the upper limit of normal. <br/ >7. Patients currently on monoclonal antibodies including antibody cocktails. <br/ >8. Patients for whom, in the opinion of the Investigator, progression to death is imminent and inevitable within the next 48 â?? 72 hours, irrespective of the provision of treatment. <br/ >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. <br/ >10. Possibility of the patient being discharged from hospital within 24 hours. <br/ >11. Participation in other anti-COVID-19 interventional trials. <br/ >12. Other known active infections or other clinical conditions (e.g., chronic obstructive pulmonary disease) that contraindicate aerosolized inhalation, coexisting pneumonia is allowed. <br/ >13. Patients with known instance of angina or myocardial infarction prior to 3 months of screening visit. <br/ >14. Patients with current or prior psychiatric illness, seizure disorders, autoimmune disorders, pre-existing severe cardiovascular disease and patients with prior transplants. <br/ >15. Females who are breast-feeding, lactating, pregnant or intending to become pregnant. <br/ >16. Diagnosed for hepatitis B, hepatitis C or uncontrolled HIV. <br/ >17. Presenting, in the opinion of the Investigator, a clinically significant abnormality with regard to the clinical examination and/or clinical chemistry screening parameters. <br/ >18. History of cancer in the last 5 years, or currently has cancer, as assessed by Investigator. <br/ >19. Has a history of, or current neurological (neurodegenerative diseases, epilepsy) or psychiatric pathology that may impact the participantâ??s ability to comply with the requirements of the protocol, as assessed by Investigator. <br/ >20. Frequent consumption of alcohol ( > 2 standard servings of alcohol/day on average). <br/ >21. History of (assessed by PI) or current tobacco use. <br/ >22. Patients with history of drug abuse (amphetamines, Cannabinoids, Cocaine and Opiates) <br/ >23. Inability to provide blood and/or urine samples. <br/ >24. Any condition that could, in the opinion of the investigator, preclude the participantâ??s ability to successfully and safely complete the study or that may confound study outcomes. <br/ >

1. Hospitalized for more than 48 hours. <br/ >2. FBG levels â?¥ 200 mg/dL <br/ >3. Known or suspected allergy to any of the ingredients in the investigational product or standardized meals. <br/ >4. Currently undergoing invasive mechanical ventilation (including venous ECMO) at the time of screening. (WHO category 6 and 7). <br/ >5. ALT/AST > 2.5 times the upper limit of normal or a history of decompensated cirrhosis. <br/ >6. Serum creatinine > 2 times the upper limit of normal. <br/ >7. Patients currently on monoclonal antibodies including antibody cocktails. <br/ >8. Patients for whom, in the opinion of the Investigator, progression to death is imminent and inevitable within the next 48 â?? 72 hours, irrespective of the provision of treatment. <br/ >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. <br/ >10. Possibility of the patient being discharged from hospital within 24 hours. <br/ >11. Participation in other anti-COVID-19 interventional trials. <br/ >12. Other known active infections or other clinical conditions (e.g., chronic obstructive pulmonary disease) that contraindicate aerosolized inhalation, coexisting pneumonia is allowed. <br/ >13. Patients with known instance of angina or myocardial infarction prior to 3 months of screening visit. <br/ >14. Patients with current or prior psychiatric illness, seizure disorders, autoimmune disorders, pre-existing severe cardiovascular disease and patients with prior transplants. <br/ >15. Females who are breast-feeding, lactating, pregnant or intending to become pregnant. <br/ >16. Diagnosed for hepatitis B, hepatitis C or uncontrolled HIV. <br/ >17. Presenting, in the opinion of the Investigator, a clinically significant abnormality with regard to the clinical examination and/or clinical chemistry screening parameters. <br/ >18. History of cancer in the last 5 years, or currently has cancer, as assessed by Investigator. <br/ >19. Has a history of, or current neurological (neurodegenerative diseases, epilepsy) or psychiatric pathology that may impact the participantâ??s ability to comply with the requirements of the protocol, as assessed by Investigator. <br/ >20. Frequent consumption of alcohol ( > 2 standard servings of alcohol/day on average). <br/ >21. History of (assessed by PI) or current tobacco use. <br/ >22. Patients with history of drug abuse (amphetamines, Cannabinoids, Cocaine and Opiates) <br/ >23. Inability to provide blood and/or urine samples. <br/ >24. Any condition that could, in the opinion of the investigator, preclude the participantâ??s ability to successfully and safely complete the study or that may confound study outcomes. <br/ >