Created at Source Raw Value Validated value
June 16, 2021, 12:32 a.m. usa

None

None

Dec. 19, 2020, 12:31 a.m. usa

1. receipt of any blood product in past 120 days 2. allergic rhinitis, chronic sinusitis, or other nasal inflammatory disease that requires daily intranasal or oral medication 3. chronic medical problems that require daily nasal administration of medication 4. prior nasal or sinus surgery including trans nasal approaches to brain 5. chronic pulmonary conditions including severe asthma, copd, or chronic bronchitis 6. autoimmune hepatitis, decompensated liver disease, cardiac ischemia, congestive heart failure, cardiac arrhythmia, neutropenia, thrombocytopenia, severe renal insufficiency 7. psychiatric or cognitive illness or recreational drug/alcohol use that in the opinion of the principal investigator, would affect subject safety and/or compliance 8. symptoms consistent with covid-19 infection (fevers, acute onset cough, shortness of breath) at time of screening 9. nucleic acid testing evidence of covid-19 infection at time of screening or on day 0 10. inability to complete therapy with the study product within 24 hours after enrollment 11. patients must not be pregnant or nursing due to the unknown potential for congenital abnormalities and the potential of this regimen to harm nursing infants. 12. has a diagnosis of primary immunodeficiency 13. has active autoimmune disease that has required systemic treatment in the past 1 year 1. (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs) 2. replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is acceptable 14. has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is not in the best interest of the patient to participate, in the opinion of the treating investigator 15. principle investigator believes that for one or multiple reasons the patient will be unable to comply with all study visits, or if they believe the trial is not clinically in the best interest of the patient 16. documented allergic or hypersensitivity response to any protein therapeutics (e.g., recombinant proteins, vaccines, intravenous immune globulins, monoclonal antibodies, receptor traps) 17. active, untreated tuberculosis

1. receipt of any blood product in past 120 days 2. allergic rhinitis, chronic sinusitis, or other nasal inflammatory disease that requires daily intranasal or oral medication 3. chronic medical problems that require daily nasal administration of medication 4. prior nasal or sinus surgery including trans nasal approaches to brain 5. chronic pulmonary conditions including severe asthma, copd, or chronic bronchitis 6. autoimmune hepatitis, decompensated liver disease, cardiac ischemia, congestive heart failure, cardiac arrhythmia, neutropenia, thrombocytopenia, severe renal insufficiency 7. psychiatric or cognitive illness or recreational drug/alcohol use that in the opinion of the principal investigator, would affect subject safety and/or compliance 8. symptoms consistent with covid-19 infection (fevers, acute onset cough, shortness of breath) at time of screening 9. nucleic acid testing evidence of covid-19 infection at time of screening or on day 0 10. inability to complete therapy with the study product within 24 hours after enrollment 11. patients must not be pregnant or nursing due to the unknown potential for congenital abnormalities and the potential of this regimen to harm nursing infants. 12. has a diagnosis of primary immunodeficiency 13. has active autoimmune disease that has required systemic treatment in the past 1 year 1. (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs) 2. replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is acceptable 14. has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is not in the best interest of the patient to participate, in the opinion of the treating investigator 15. principle investigator believes that for one or multiple reasons the patient will be unable to comply with all study visits, or if they believe the trial is not clinically in the best interest of the patient 16. documented allergic or hypersensitivity response to any protein therapeutics (e.g., recombinant proteins, vaccines, intravenous immune globulins, monoclonal antibodies, receptor traps) 17. active, untreated tuberculosis