Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-25 @ 1:46 AM
NCT ID:
NCT04906694
Eligibility Criteria:
Inclusion Criteria:
* Positive for COVID-19 with any approved RT-PCR or rapid antigen test within 7 days of planned treatment
* Either have no COVID-19 symptoms (asymptomatic) or mild symptoms
* Must be willing and able to comply with all planned study procedures and be available for all study visits and follow-up as required by this protocol
* Subject must have provided written informed consent which includes signing the institutional review board or independent ethics committee approved consent form prior to participating in any study related activity
* Willing to follow contraception guidelines
Exclusion Criteria:
* 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT04906694
Study Brief:
Protocol Section:
NCT04906694