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 @ 12:43 AM
Ignite Modification Date:
2025-12-25 @ 12:43 AM
NCT ID:
NCT04414267
Eligibility Criteria:
Inclusion Criteria:
1. Written informed consent
2. Male or female
3. Age more than or equal to 50 years based on the precise date of birth. Female participants are allowed on the premise that they are post-menopausal.
4. History of at least one of the following:
1. coronary heart disease;
2. chronic obstructive pulmonary disease;
3. Charlson's comorbidity index (CCI) more than 3
5. Negative serum testing for immunoglobulin G and M against SARS-CoV-2
6. Skin tuberculin test diameter less than 10mm
Exclusion Criteria:
* Deny to written informed consent
* Age less than 50 years
* Known infection by the Human Immunodeficiency Virus-1 (HIV-1)
* Severely immunocompromised patients. This exclusion category comprises:
* History of congenital immunodeficiency
* History of solid organ transplantation
* History of bone marrow transplantation
* Intake of chemotherapy the last two months
* Intake of radiotherapy the last two months
* Active hematological or solid tumor malignancy
* History of any anti-cytokine therapies
* History of oral or intravenous steroids defined as daily doses of 10mg prednisone or equivalent for longer than the last 3 months
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
50 Years
Study:
NCT04414267
Study Brief:
Protocol Section:
NCT04414267