Created at Source Raw Value Validated value
Nov. 16, 2021, 6:30 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) 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. has a documented infection other than covid-19 pregnant or lactating women who are breast feeding or planning on either during the study has participated or is participating in a clinical research study evaluating covid-19 convalescent plasma, monoclonal antibodies (mabs) against sars-cov-2, or intravenous immunoglobulin (ivig) within 3 months or less than 5 half-lives of the investigational product (whichever is longer) prior to the screening visit has a high risk of progressing to severe covid-19 per cdc's risk stratification (see: https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-with-medical-conditions.html) is an immunocompromised subject even if previously fully vaccinated against covid-19 or recovered from a prior covid-19 infection.

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) 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. has a documented infection other than covid-19 pregnant or lactating women who are breast feeding or planning on either during the study has participated or is participating in a clinical research study evaluating covid-19 convalescent plasma, monoclonal antibodies (mabs) against sars-cov-2, or intravenous immunoglobulin (ivig) within 3 months or less than 5 half-lives of the investigational product (whichever is longer) prior to the screening visit has a high risk of progressing to severe covid-19 per cdc's risk stratification (see: https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-with-medical-conditions.html) is an immunocompromised subject even if previously fully vaccinated against covid-19 or recovered from a prior covid-19 infection.

Aug. 4, 2021, 2 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) - 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. - has a documented infection other than covid-19 - pregnant or lactating women who are breast feeding or planning on either during the study - has participated or is participating in a clinical research study evaluating covid-19 convalescent plasma, monoclonal antibodies (mabs) against sars-cov-2, or intravenous immunoglobulin (ivig) within 3 months or less than 5 half-lives of the investigational product (whichever is longer) prior to the screening visit - has a high risk of progressing to severe covid-19 per cdc's risk stratification (see: https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-with-medical-c onditions.html) - is an immunocompromised subject even if previously fully vaccinated against covid-19 or recovered from a prior covid-19 infection.

- 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) - 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. - has a documented infection other than covid-19 - pregnant or lactating women who are breast feeding or planning on either during the study - has participated or is participating in a clinical research study evaluating covid-19 convalescent plasma, monoclonal antibodies (mabs) against sars-cov-2, or intravenous immunoglobulin (ivig) within 3 months or less than 5 half-lives of the investigational product (whichever is longer) prior to the screening visit - has a high risk of progressing to severe covid-19 per cdc's risk stratification (see: https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-with-medical-c onditions.html) - is an immunocompromised subject even if previously fully vaccinated against covid-19 or recovered from a prior covid-19 infection.

May 31, 2021, 12:32 a.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) - 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. - has a documented infection other than covid-19 - pregnant or lactating women who are breast feeding or planning on either during the study - has participated or is participating in a clinical research study evaluating covid-19 convalescent plasma, monoclonal antibodies (mabs) against sars-cov-2, or intravenous immunoglobulin (ivig) 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) - 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. - has a documented infection other than covid-19 - pregnant or lactating women who are breast feeding or planning on either during the study - has participated or is participating in a clinical research study evaluating covid-19 convalescent plasma, monoclonal antibodies (mabs) against sars-cov-2, or intravenous immunoglobulin (ivig) within 3 months or less than 5 half-lives of the investigational product (whichever is longer) prior to the screening visit