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 @ 12:26 AM
Ignite Modification Date:
2025-12-25 @ 12:26 AM
NCT ID:
NCT04844658
Eligibility Criteria:
Inclusion Criteria:
* Adult ≥ 18 years of age at the time of inclusion in the study;
* Recently hospitalized patients in whom SARS CoV-2 infection has been laboratory confirmed by RT-PCR or other commercial or public health test on any sample.
* Severity of 3-4-5 according to the WHO 7-point ordinal scale (3: hospitalized, no oxygen therapy; 4: hospitalized, oxygen by mask or nasal prongs; 5:non-invasive ventilation or high-flow oxygen);
* Subject (or authorized legal representative) who can provide oral or written informed consent before beginning any study procedure;
* Understand and agree to abide by the study procedures.
Exclusion Criteria:
* Contra-indication to NASAFYTOL® or constituents (incl. Vit D): hypersensitivity or allergy to product components;
* Swallowing disorder or inability to take oral caps;
* Presence of comorbidities that imply a poor prognosis (according to clinical judgment);
* Pregnancy or breastfeeding women; If patient is a female of childbearing potential, patient must use an effective means of birth control (oral, intravaginal or transdermal oestrogen-progestogen combined hormonal contraceptives or intrauterine devices or sexual abstinence);
* Serious or active bacterial infections or documented sepsis by pathogens other than SARS-CoV-2;
* Patients participating in clinical trials of other products; Patients presenting acute impairment of renal function or nephrolithiasis; ALT/AST\> 5 times the normal limit, or Neutropenia (Absolute neutrophil count \< 500/uL), or Thrombocytopenia (Platelets \< 50,000/uL).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04844658
Study Brief:
Protocol Section:
NCT04844658