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:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2025-12-24 @ 10:55 PM
NCT ID:
NCT06452069
Eligibility Criteria:
Inclusion Criteria:
* Patients must be between 18\<X\< 65 years of age.
* The participant must be willing and able to give written informed consent. The volunteer must provide his/her consent on his or her behalf, a legally acceptable representative (i.e., an International Harmonization Council \[ICH\] and adopted by local law as appropriate can be used) must give informed consent on his/her behalf.
* PCR test COVID-19 positive diagnosis and mild to moderate disease stage is required.
* The participant must agree not to receive vaccines administered for COVID-19 during the study.
Exclusion Criteria:
* Patients \< 18 years of age,
* Positive diagnosis of severe COVID-19 with symptoms of basic severity: patients with respiratory distress, signs of mental confusion and impaired consciousness that develop depending on the severity of the stage of the disease,
* Patients on active antiviral therapy,
* Patients with creatine clearance \< 30 ml/min and renal impairment,
* NYHA III-IV, Stage D heart failure patients requiring frequent hospitalization,
* Uncontrolled coagulopathy,
* Patients with advanced liver failure,
* Patients with active infections such as hepatitis B, hepatitis C and HIV, diseases requiring systemic treatment,
* Patients with active malignancy and known history of cancer,
* Those who do not have sufficient psychic state to disrupt working rounds,
* Active drug users,
* Known hypersensitivity and allergic reaction to the components of the preparation,
* Current participation in another interventional treatment study with an investigational agent,
* Recent use of the investigational product within 28 days of the first dose of the investigational product use or presence of a research device during screening,
* Pregnant or breastfeeding women,
* Patients who did not give written informed consent.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT06452069
Study Brief:
Protocol Section:
NCT06452069