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 @ 4:12 AM
Ignite Modification Date:
2025-12-25 @ 4:12 AM
NCT ID:
NCT05234320
Eligibility Criteria:
Stage I Inclusion Criteria
1. Age ≥ 18 years in healthy condition
2. Able and willing to sign ICF
Stage I Exclusion Criteria
1. Known hypersensitivity to any of the DP ingredients.
2. Pregnant or lactating woman.
3. Participation in another clinical study within 4 weeks from screening
4. Patient has a positive test for HBV, HCV or HIV
5. Subjects diagnosed with allergic rhinitis and/or deviated septum and/or sinusitis.
6. Any medical condition that in the investigator's opinion will jeopardize the patient's ability to follow the protocol.
Stage II Inclusion Criteria
1. Age ≥ 18 years
2. Laboratory confirmed SARS-CoV2 Infection by nasopharyngeal RT-PCR.
3. COVID-19 symptoms within 3 days of symptoms onset
4. Patients diagnosed with COVID-19 that are not hospitalized (classified on the NIAID 8-point ordinal scale as 1 or 2).
Stage II Exclusion Criteria
1. Patients who may require hospitalization during the study
2. Immunocompromised COVID-19 patients.
3. Known hypersensitivity to any of the DP ingredients.
4. Patient has a positive test for HBV, HCV or HIV
5. Pregnant or lactating woman.
6. Participation in another clinical study within 4 weeks from screening
7. Subjects diagnosed with allergic rhinitis and/or deviated septum and/or sinusitis.
8. Any medical condition that in the investigator's opinion will jeopardize the patient's ability to follow the protocol.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05234320
Study Brief:
Protocol Section:
NCT05234320