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 @ 4:59 AM
Ignite Modification Date:
2025-12-25 @ 4:59 AM
NCT ID:
NCT04412018
Eligibility Criteria:
Inclusion Criteria:
1. Positive local SARS-CoV-2 test result within the preceding 72 hours
2. At least one of the following symptoms
1. Fever
2. Cough
3. Sore throat
4. Shortness of breath
5. Myalgia
Exclusion Criteria:
1. Individuals currently participating in another interventional trial that will or may interfere with the primary outcome
2. Hospitalized individuals
3. Individuals who have a current medical condition for which life expectancy is less than 3 months
4. Individuals with a history of acute end-organ injury (e.g. myocardial infarction, stroke, hospitalization for acute lung, liver or kidney disease) within the last month
5. Individuals with active severe liver disease
6. Individuals with a history of acute or chronic pancreatitis
7. Women who are pregnant, may be pregnant, are planning on becoming pregnant, or are lactating
8. Women of child-bearing potential who are not using at least one form of highly effective (hormonal contraceptives \[e.g. combined oral contraceptives, patch, vaginal ring, injectables, and implants\]; intrauterine device or intrauterine system; tubal ligation or whose partner has had a vasectomy) and one effective (barrier methods such male condom, female condom, cervical cap, diaphragm, or contraceptive sponge) method of contraception
9. Individuals with a history of hemodynamic instability within past 72 hours including a systolic blood pressure of \<95 mmHg and/or a diastolic blood pressure of \<50 mmHg
10. Individuals with known hypersensitivity to fish and/or shellfish, or ingredients of IPE
11. Individuals with any other condition which, in the opinion of the Investigator, would place the participant at increased risk, preclude obtaining voluntary consent or confound the objectives of study
12. Individuals who are unable to swallow IPE capsules whole
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT04412018
Study Brief:
Protocol Section:
NCT04412018