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 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 12:36 AM
NCT ID:
NCT04914767
Eligibility Criteria:
Inclusion Criteria: patients included in the two studies NIGCOV1 and NIGCOV2 must be:
* Men and women at least 40 years old, able and willing to give informed consent;
* Ambulatory (NIGCOV1) or hospitalized (NIGCOV2) environment;
* Patient with dyspnea or with a positive gait test (NIGCOV2);
* The patient must have at least one of the following high risk criteria: 70 years or older, obesity (BMI ≥ 30 kg / m2), diabetes mellitus, uncontrolled hypertension (systolic blood pressure ≥ 150 mm Hg), respiratory disease known (including asthma or chronic obstructive pulmonary disease), known heart failure, known coronary artery disease, fever ≥ 38.4 ° C within the last 48 hours, dyspnea at the time of presentation (only patients included on NIGCOV2), bicytopenia, pancytopenia or a combination of a number high neutrophils and low lymphocytes count (only patients included on NIGCOV2);
* The patient is not of childbearing age, defined as postmenopausal for at least 1 year or surgically sterile, or is of childbearing age and uses at least one method of contraception and preferably two complementary forms of contraception comprising a method of barrier throughout the study and for 30 days after the end of the study;
* The patient must be able and willing to comply with the requirements of this study protocol.
Exclusion Criteria:
* Patient currently in shock or exhibiting hemodynamic instability;
* Patient with inflammatory bowel disease (Crohn's disease or ulcerative colitis), chronic diarrhea or malabsorption;
* Pregnant or breastfeeding patient
* Patient with a history of allergic reaction or significant sensitivity to Nigella;
* The patient is considered by the investigator, for whatever reason, to be an unsuitable candidate for the study.
Given the non-homogeneity of the patients, the study population will be divided into two groups:
* group of outpatients: Ambulatory patients = NIGCOV1 study
* and inpatient group: Hospitalised patients = NIGCOV2 study Statistical analysis will be carried out for each group separately
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Study:
NCT04914767
Study Brief:
Protocol Section:
NCT04914767