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 @ 11:39 PM
Ignite Modification Date:
2025-12-24 @ 11:39 PM
NCT ID:
NCT04978051
Eligibility Criteria:
Inclusion Criteria:
1. adult patients (18 years or older), both sexes
2. Sars-CoV-2 infection confirmed by PCR less than 4 days before randomization
3. hospitalized with a diagnosis of SARS-CoV-2 pneumonia
4. radiographic evidence of pulmonary infiltrates
5. grade 4 or 5 on the ordinal scale for the evaluation of the patient's clinical condition
6. pO2/FiO2 \<380
7. men and women of childbearing age who have heterosexual relations must be agreement to use the safe method(s) of contraception
8. obtaining the informed consent of the patient or the legal representative.
Exclusion Criteria:
1. imminent death (life expectancy less than 72h)
2. known hypersensitivity or known adverse reactions to the study drug, or its metabolites or excipients of the formulation
3. invasive mechanical ventilation
4. participation in any other clinical trial
5. ALT or AST \> 5 x ULN
6. creatinine clearance \<50 mL/min using the Cockcroft-Gault formula for participants '18 years old \[Cockcroft 1976\]
7. patients with recent acute coronary syndrome (\<1 month)
8. patients with a history of stroke
9. positive pregnancy test
10. pregnant or lactating woman
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04978051
Study Brief:
Protocol Section:
NCT04978051