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

* in the investigator's opinion, has moderate or severe symptoms or rapidly progressive symptoms which are likely to progress such that a hospitalization is imminent (within 24-48 hours) * currently using chronic oxygen therapy due to an underlying comorbidity and requires an increase in baseline oxygen flow rate due to covid-19 infection * is an immunocompromised subject even if previously fully vaccinated against covid-19 or recovered from a prior covid-19 infection * has an active documented infection other than covid-19 * any medical condition that, in the investigator's opinion, could adversely impact safety or key objectives of the study, particularly any intranasal pathology or disease process * pregnant or lactating women who are breast feeding or planning on either during the study * has received within the 30 days prior to screening or is planning on receiving an eua-cleared monoclonal antibody (mab) during the study * has participated or is participating in a clinical research study evaluating covid-19 convalescent plasma, other non-eua-cleared mabs against covid-19 or intravenous immunoglobulin within 3 months or less than 5 half-lives of the investigational product (whichever is longer) prior to the screening visit

* in the investigator's opinion, has moderate or severe symptoms or rapidly progressive symptoms which are likely to progress such that a hospitalization is imminent (within 24-48 hours) * currently using chronic oxygen therapy due to an underlying comorbidity and requires an increase in baseline oxygen flow rate due to covid-19 infection * is an immunocompromised subject even if previously fully vaccinated against covid-19 or recovered from a prior covid-19 infection * has an active documented infection other than covid-19 * any medical condition that, in the investigator's opinion, could adversely impact safety or key objectives of the study, particularly any intranasal pathology or disease process * pregnant or lactating women who are breast feeding or planning on either during the study * has received within the 30 days prior to screening or is planning on receiving an eua-cleared monoclonal antibody (mab) during the study * has participated or is participating in a clinical research study evaluating covid-19 convalescent plasma, other non-eua-cleared mabs against covid-19 or intravenous immunoglobulin within 3 months or less than 5 half-lives of the investigational product (whichever is longer) prior to the screening visit

Oct. 14, 2021, 2:24 p.m. usa

- in the investigator's opinion, has moderate or severe symptoms or rapidly progressive symptoms which are likely to progress such that a hospitalization is imminent (within 24-48 hours) - currently using chronic oxygen therapy due to an underlying comorbidity and requires an increase in baseline oxygen flow rate due to covid-19 infection - is an immunocompromised subject even if previously fully vaccinated against covid-19 or recovered from a prior covid-19 infection - has an active documented infection other than covid-19 - any medical condition that, in the investigator's opinion, could adversely impact safety or key objectives of the study, particularly any intranasal pathology or disease process - pregnant or lactating women who are breast feeding or planning on either during the study - has received within the 30 days prior to screening or is planning on receiving an eua-cleared monoclonal antibody (mab) during the study - has participated or is participating in a clinical research study evaluating covid-19 convalescent plasma, other non-eua-cleared mabs against covid-19 or intravenous immunoglobulin within 3 months or less than 5 half-lives of the investigational product (whichever is longer) prior to the screening visit

- in the investigator's opinion, has moderate or severe symptoms or rapidly progressive symptoms which are likely to progress such that a hospitalization is imminent (within 24-48 hours) - currently using chronic oxygen therapy due to an underlying comorbidity and requires an increase in baseline oxygen flow rate due to covid-19 infection - is an immunocompromised subject even if previously fully vaccinated against covid-19 or recovered from a prior covid-19 infection - has an active documented infection other than covid-19 - any medical condition that, in the investigator's opinion, could adversely impact safety or key objectives of the study, particularly any intranasal pathology or disease process - pregnant or lactating women who are breast feeding or planning on either during the study - has received within the 30 days prior to screening or is planning on receiving an eua-cleared monoclonal antibody (mab) during the study - has participated or is participating in a clinical research study evaluating covid-19 convalescent plasma, other non-eua-cleared mabs against covid-19 or intravenous immunoglobulin within 3 months or less than 5 half-lives of the investigational product (whichever is longer) prior to the screening visit