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June 25, 2024, noon usa

1. hospitalized patients 2. patients who have received or are receiving other treatments that are not approved/authorized by the relevant regulatory authority for the treatment of patients with mild or moderate covid-19 in an outpatient setting 3. patients enrolled in interventional clinical trials for other experimental therapies 4. patients on chronic oxygen supplementation due to cardiopulmonary or other conditions 5. patients with unstable comorbid conditions (e.g., decompensated congestive heart failure, copd with exacerbation, current angina pectoris, uncontrolled diabetes mellitus, uncontrolled hypertension, uncontrolled asthma) 6. patients with severe pulmonary comorbid conditions, including systemic steroid-dependent asthma, systemic steroid-dependent copd, oxygen-dependent copd, lung transplant, or cystic fibrosis 7. patients who have received highly immunosuppressive therapy (to include systemic corticosteroids) or anti-cancer combination chemotherapy within 24 hours prior to first dose of study drug 8. patients with known or suspected intolerance or hypersensitivity to sargramostim, or any component of the product 9. patients who have previously experienced severe and unexplained side effects during aerosol delivery of any kind of medical product 10. pregnant or breastfeeding females 11. patients who, in the opinion of the investigator, will not be able to comply with all the study procedures and visits as outlined in the schedule of events, including follow-up

1. hospitalized patients 2. patients who have received or are receiving other treatments that are not approved/authorized by the relevant regulatory authority for the treatment of patients with mild or moderate covid-19 in an outpatient setting 3. patients enrolled in interventional clinical trials for other experimental therapies 4. patients on chronic oxygen supplementation due to cardiopulmonary or other conditions 5. patients with unstable comorbid conditions (e.g., decompensated congestive heart failure, copd with exacerbation, current angina pectoris, uncontrolled diabetes mellitus, uncontrolled hypertension, uncontrolled asthma) 6. patients with severe pulmonary comorbid conditions, including systemic steroid-dependent asthma, systemic steroid-dependent copd, oxygen-dependent copd, lung transplant, or cystic fibrosis 7. patients who have received highly immunosuppressive therapy (to include systemic corticosteroids) or anti-cancer combination chemotherapy within 24 hours prior to first dose of study drug 8. patients with known or suspected intolerance or hypersensitivity to sargramostim, or any component of the product 9. patients who have previously experienced severe and unexplained side effects during aerosol delivery of any kind of medical product 10. pregnant or breastfeeding females 11. patients who, in the opinion of the investigator, will not be able to comply with all the study procedures and visits as outlined in the schedule of events, including follow-up

Nov. 16, 2021, 6:30 p.m. usa

hospitalized patients patients who have received or are receiving other treatments that are not approved/authorized by the relevant regulatory authority for the treatment of patients with mild or moderate covid-19 in an outpatient setting patients enrolled in interventional clinical trials for other experimental therapies patients on chronic oxygen supplementation due to cardiopulmonary or other conditions patients with unstable comorbid conditions (e.g., decompensated congestive heart failure, copd with exacerbation, current angina pectoris, uncontrolled diabetes mellitus, uncontrolled hypertension, uncontrolled asthma) patients with severe pulmonary comorbid conditions, including systemic steroid-dependent asthma, systemic steroid-dependent copd, oxygen-dependent copd, lung transplant, or cystic fibrosis patients who have received highly immunosuppressive therapy (to include systemic corticosteroids) or anti-cancer combination chemotherapy within 24 hours prior to first dose of study drug patients with known or suspected intolerance or hypersensitivity to sargramostim, or any component of the product patients who have previously experienced severe and unexplained side effects during aerosol delivery of any kind of medical product pregnant or breastfeeding females patients who, in the opinion of the investigator, will not be able to comply with all the study procedures and visits as outlined in the schedule of events, including follow-up

hospitalized patients patients who have received or are receiving other treatments that are not approved/authorized by the relevant regulatory authority for the treatment of patients with mild or moderate covid-19 in an outpatient setting patients enrolled in interventional clinical trials for other experimental therapies patients on chronic oxygen supplementation due to cardiopulmonary or other conditions patients with unstable comorbid conditions (e.g., decompensated congestive heart failure, copd with exacerbation, current angina pectoris, uncontrolled diabetes mellitus, uncontrolled hypertension, uncontrolled asthma) patients with severe pulmonary comorbid conditions, including systemic steroid-dependent asthma, systemic steroid-dependent copd, oxygen-dependent copd, lung transplant, or cystic fibrosis patients who have received highly immunosuppressive therapy (to include systemic corticosteroids) or anti-cancer combination chemotherapy within 24 hours prior to first dose of study drug patients with known or suspected intolerance or hypersensitivity to sargramostim, or any component of the product patients who have previously experienced severe and unexplained side effects during aerosol delivery of any kind of medical product pregnant or breastfeeding females patients who, in the opinion of the investigator, will not be able to comply with all the study procedures and visits as outlined in the schedule of events, including follow-up

Oct. 25, 2021, 10:30 a.m. usa

1. hospitalized patients 2. patients who have received or are receiving other treatments that are not approved/authorized by the relevant regulatory authority for the treatment of patients with mild or moderate covid-19 in an outpatient setting 3. patients enrolled in interventional clinical trials for other experimental therapies 4. patients on chronic oxygen supplementation due to cardiopulmonary or other conditions 5. patients with unstable comorbid conditions (e.g., decompensated congestive heart failure, copd with exacerbation, current angina pectoris, uncontrolled diabetes mellitus, uncontrolled hypertension, uncontrolled asthma) 6. patients with severe pulmonary comorbid conditions, including systemic steroid-dependent asthma, systemic steroid-dependent copd, oxygen-dependent copd, lung transplant, or cystic fibrosis 7. patients who have received highly immunosuppressive therapy (to include systemic corticosteroids) or anti-cancer combination chemotherapy within 24 hours prior to first dose of study drug 8. patients with known or suspected intolerance or hypersensitivity to sargramostim, or any component of the product 9. patients who have previously experienced severe and unexplained side effects during aerosol delivery of any kind of medical product 10. pregnant or breastfeeding females 11. patients who, in the opinion of the investigator, will not be able to comply with all the study procedures and visits as outlined in the schedule of events, including follow-up

1. hospitalized patients 2. patients who have received or are receiving other treatments that are not approved/authorized by the relevant regulatory authority for the treatment of patients with mild or moderate covid-19 in an outpatient setting 3. patients enrolled in interventional clinical trials for other experimental therapies 4. patients on chronic oxygen supplementation due to cardiopulmonary or other conditions 5. patients with unstable comorbid conditions (e.g., decompensated congestive heart failure, copd with exacerbation, current angina pectoris, uncontrolled diabetes mellitus, uncontrolled hypertension, uncontrolled asthma) 6. patients with severe pulmonary comorbid conditions, including systemic steroid-dependent asthma, systemic steroid-dependent copd, oxygen-dependent copd, lung transplant, or cystic fibrosis 7. patients who have received highly immunosuppressive therapy (to include systemic corticosteroids) or anti-cancer combination chemotherapy within 24 hours prior to first dose of study drug 8. patients with known or suspected intolerance or hypersensitivity to sargramostim, or any component of the product 9. patients who have previously experienced severe and unexplained side effects during aerosol delivery of any kind of medical product 10. pregnant or breastfeeding females 11. patients who, in the opinion of the investigator, will not be able to comply with all the study procedures and visits as outlined in the schedule of events, including follow-up

June 27, 2021, 2:30 a.m. usa

1. hospitalized patients 2. patients who have received or are receiving other approved/authorized treatments to prevent progression of covid-19 disease severity, including but not limited to: 1. monoclonal antibodies e.g., bamlanivimab, bamlanivimab plus etesevimab, casirivimab plus imdevimab 2. antiviral agents e.g., remdesivir 3. other covid-19 therapies used as part of the standard of care, e.g., convalescent plasma, dexamethasone, baricitinib 4. patients who have started but not completed a covid-19 vaccination regimen 3. patients enrolled in interventional clinical trials for other experimental therapies 4. patients on chronic oxygen supplementation due to cardiopulmonary or other conditions 5. patients with unstable comorbid conditions (e.g., decompensated congestive heart failure, copd with exacerbation, current angina pectoris, uncontrolled diabetes mellitus, uncontrolled hypertension, uncontrolled asthma) 6. patients with severe pulmonary comorbid conditions, including systemic steroid-dependent asthma, systemic steroid-dependent copd, oxygen-dependent copd, lung transplant, or cystic fibrosis 7. patients who have received highly immunosuppressive therapy (to include systemic corticosteroids) or anti-cancer combination chemotherapy within 24 hours prior to first dose of study drug 8. patients with known or suspected intolerance or hypersensitivity to sargramostim, or any component of the product 9. patients who have previously experienced severe and unexplained side effects during aerosol delivery of any kind of medical product 10. pregnant or breastfeeding females 11. patients who, in the opinion of the investigator, will not be able to comply with all the study procedures and visits as outlined in the schedule of events, including follow-up

1. hospitalized patients 2. patients who have received or are receiving other approved/authorized treatments to prevent progression of covid-19 disease severity, including but not limited to: 1. monoclonal antibodies e.g., bamlanivimab, bamlanivimab plus etesevimab, casirivimab plus imdevimab 2. antiviral agents e.g., remdesivir 3. other covid-19 therapies used as part of the standard of care, e.g., convalescent plasma, dexamethasone, baricitinib 4. patients who have started but not completed a covid-19 vaccination regimen 3. patients enrolled in interventional clinical trials for other experimental therapies 4. patients on chronic oxygen supplementation due to cardiopulmonary or other conditions 5. patients with unstable comorbid conditions (e.g., decompensated congestive heart failure, copd with exacerbation, current angina pectoris, uncontrolled diabetes mellitus, uncontrolled hypertension, uncontrolled asthma) 6. patients with severe pulmonary comorbid conditions, including systemic steroid-dependent asthma, systemic steroid-dependent copd, oxygen-dependent copd, lung transplant, or cystic fibrosis 7. patients who have received highly immunosuppressive therapy (to include systemic corticosteroids) or anti-cancer combination chemotherapy within 24 hours prior to first dose of study drug 8. patients with known or suspected intolerance or hypersensitivity to sargramostim, or any component of the product 9. patients who have previously experienced severe and unexplained side effects during aerosol delivery of any kind of medical product 10. pregnant or breastfeeding females 11. patients who, in the opinion of the investigator, will not be able to comply with all the study procedures and visits as outlined in the schedule of events, including follow-up

March 4, 2021, 12:31 a.m. usa

1. hospitalized patients 2. patients who have received or are receiving other approved/authorized treatments to prevent progression of covid-19 disease severity, including but not limited to: 1. monoclonal antibodies e.g., bamlanivimab, casirivimab plus imdevimab 2. antiviral agents e.g., remdesivir 3. other covid-19 therapies used as part of the standard of care, e.g., convalescent plasma, dexamethasone, baricitinib 3. patients enrolled in interventional clinical trials for other experimental therapies 4. patients on chronic oxygen supplementation due to cardiopulmonary or other conditions 5. patients with unstable comorbid conditions (e.g., decompensated congestive heart failure, copd with exacerbation, current angina pectoris, uncontrolled diabetes mellitus, uncontrolled hypertension, uncontrolled asthma) 6. patients with severe pulmonary comorbid conditions, including systemic steroid-dependent asthma, systemic steroid-dependent copd, oxygen-dependent copd, lung transplant, or cystic fibrosis 7. patients who have received highly immunosuppressive therapy (to include systemic corticosteroids) or anti-cancer combination chemotherapy within 24 hours prior to first dose of study drug 8. patients with known or suspected intolerance or hypersensitivity to sargramostim, or any component of the product 9. patients who have previously experienced severe and unexplained side effects during aerosol delivery of any kind of medical product 10. pregnant or breastfeeding females 11. patients who, in the opinion of the investigator, will not be able to comply with all the study procedures and visits as outlined in the schedule of events, including follow-up

1. hospitalized patients 2. patients who have received or are receiving other approved/authorized treatments to prevent progression of covid-19 disease severity, including but not limited to: 1. monoclonal antibodies e.g., bamlanivimab, casirivimab plus imdevimab 2. antiviral agents e.g., remdesivir 3. other covid-19 therapies used as part of the standard of care, e.g., convalescent plasma, dexamethasone, baricitinib 3. patients enrolled in interventional clinical trials for other experimental therapies 4. patients on chronic oxygen supplementation due to cardiopulmonary or other conditions 5. patients with unstable comorbid conditions (e.g., decompensated congestive heart failure, copd with exacerbation, current angina pectoris, uncontrolled diabetes mellitus, uncontrolled hypertension, uncontrolled asthma) 6. patients with severe pulmonary comorbid conditions, including systemic steroid-dependent asthma, systemic steroid-dependent copd, oxygen-dependent copd, lung transplant, or cystic fibrosis 7. patients who have received highly immunosuppressive therapy (to include systemic corticosteroids) or anti-cancer combination chemotherapy within 24 hours prior to first dose of study drug 8. patients with known or suspected intolerance or hypersensitivity to sargramostim, or any component of the product 9. patients who have previously experienced severe and unexplained side effects during aerosol delivery of any kind of medical product 10. pregnant or breastfeeding females 11. patients who, in the opinion of the investigator, will not be able to comply with all the study procedures and visits as outlined in the schedule of events, including follow-up

Jan. 15, 2021, 12:31 a.m. usa

1. hospitalized patients 2. patients who have received or are receiving other treatments to prevent progression of covid-19 disease severity, including but not limited to: 1. monoclonal antibodies e.g., bamlanivimab, casirivimab plus imdevimab 2. antiviral agents e.g., remdesivir 3. other covid-19 therapies used as part of the standard of care, e.g., convalescent plasma, dexamethasone 3. patients who have received a covid-19 vaccine or participated in a clinical trial for a covid19 vaccine 4. patients enrolled in interventional clinical trials for other experimental therapies 5. patients on chronic oxygen supplementation due to cardiopulmonary or other conditions 6. patients with unstable comorbid conditions (e.g., decompensated congestive heart failure (chf), copd with exacerbation, current angina pectoris, uncontrolled diabetes mellitus, uncontrolled hypertension, uncontrolled asthma) 7. patients with severe pulmonary comorbid conditions, including systemic steroid-dependent asthma, systemic steroid-dependent copd, oxygen-dependent copd, lung transplant, or cystic fibrosis 8. patients who have received highly immunosuppressive therapy (to include systemic corticosteroids) or anti-cancer combination chemotherapy within 24 hours prior to first dose of study drug 9. patients with known or suspected intolerance or hypersensitivity to sargramostim, or any component of the product 10. patients who have previously experienced severe and unexplained side effects during aerosol delivery of any kind of medical product 11. pregnant or breastfeeding females 12. patients who, in the opinion of the investigator, will not be able to comply with all the study procedures and visits as outlined in the schedule of events, including follow-up

1. hospitalized patients 2. patients who have received or are receiving other treatments to prevent progression of covid-19 disease severity, including but not limited to: 1. monoclonal antibodies e.g., bamlanivimab, casirivimab plus imdevimab 2. antiviral agents e.g., remdesivir 3. other covid-19 therapies used as part of the standard of care, e.g., convalescent plasma, dexamethasone 3. patients who have received a covid-19 vaccine or participated in a clinical trial for a covid19 vaccine 4. patients enrolled in interventional clinical trials for other experimental therapies 5. patients on chronic oxygen supplementation due to cardiopulmonary or other conditions 6. patients with unstable comorbid conditions (e.g., decompensated congestive heart failure (chf), copd with exacerbation, current angina pectoris, uncontrolled diabetes mellitus, uncontrolled hypertension, uncontrolled asthma) 7. patients with severe pulmonary comorbid conditions, including systemic steroid-dependent asthma, systemic steroid-dependent copd, oxygen-dependent copd, lung transplant, or cystic fibrosis 8. patients who have received highly immunosuppressive therapy (to include systemic corticosteroids) or anti-cancer combination chemotherapy within 24 hours prior to first dose of study drug 9. patients with known or suspected intolerance or hypersensitivity to sargramostim, or any component of the product 10. patients who have previously experienced severe and unexplained side effects during aerosol delivery of any kind of medical product 11. pregnant or breastfeeding females 12. patients who, in the opinion of the investigator, will not be able to comply with all the study procedures and visits as outlined in the schedule of events, including follow-up