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 @ 6:45 PM
Ignite Modification Date:
2025-12-24 @ 6:45 PM
NCT ID:
NCT04795557
Eligibility Criteria:
Inclusion Criteria:
* COVID-19 patients with confirmed diagnosis based on positive SARS-Cov-2 test and the symptom of at least three of Long COVID-19 symptoms including: fatigue, headache, respiration problems (dyspnea or polypnea), sweat, cognitive disorders (attention, memory, anxiety and depression), loss of smell (anosmia) and taste (ageusia), cough, pain in joints. muscles and chest.
* Post COVID-19 patients discharged from Covid Hotels isolation, after hospitals and Intensive Care Unit (ICU) admission.
* Subjects must be under observation or admitted to a controlled facility or hospital (home quarantine is not sufficient).
* Able to take medication alone.
* Able to give informed consent.
Exclusion Criteria:
* Post COVID-19 patients discharged from Covid Hotels isolation, after hospitals and Intensive Care Unit (ICU) admission and Long Covid Symptoms longer that 3 months.
* Patient admitted already under invasive mechanical ventilation;
* Patient admitted with severe acute respiratory syndrome and diagnosed with an etiologic agent other than SARS-CoV-2;
* Renal failure requiring dialysis or creatinine ≥ 2.0mg/dl;
* Tube feeding or parenteral nutrition.
* Respiratory decompensation requiring mechanical ventilation.
* Uncontrolled diabetes type 2.
* Autoimmune disease.
* Pregnant or lactating women.
* Taking antibiotics for a reason other than COVID-19 at enrollment;
* Has a chronically weakened immune system (AIDS, lymphoma, chemo-radio- corticosteroid therapy, immunosuppressive pathology);
* Was treated with chemo-radio-corticosteroid therapy in the last 6 months;
* Has active cancer;
* Taking immunosuppressive drugs (e.g. anti-rejection treatment after organ transplant);
* Already participating in another clinical trial;
* Has any other condition that would prevent safe participation in the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04795557
Study Brief:
Protocol Section:
NCT04795557