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 @ 10:06 PM
Ignite Modification Date:
2025-12-24 @ 10:06 PM
NCT ID:
NCT04668235
Eligibility Criteria:
Inclusion Criteria:
1. Individuals aged 18 or over, regardless of gender;
2. Patients hospitalized in moderate to severe stages in line with the Ministry of Health classification;
3. Positive diagnosis for SARS-CoV-2 by molecular amplification of the virus in RT-PCR diagnosed from a respiratory sample (nasopharynx, oropharyngeal, lower respiratory tract \[eg, sputum\]) collected \<96 hours before randomization;
4. Time of onset of symptoms and inclusion ≤ 14 days;
5. Internation within 48 hours after inclusion in the study;
6. Follow-up availability during the study period;
7. Voluntary membership to participate in the study and signing the Informed Consent Form.
Exclusion Criteria:
1. Patients known or suspected of being sensitive to AZVUDINE or excipients (inactive ingredients: microcrystalline cellulose, hydrated lactose, polyvinylpyrrolidone K30, croscarmellose sodium, magnesium stearate);
2. Patients diagnosed with pneumonia caused by other pathogens;
3. Patients with liver disease (total bilirubin ≥2 times above the normal limit, ALT / TGP and AST / TGO ≥5 times above the normal limit)
4. Patients with renal failure (glomerular filtration rate ≤60mL / min / 1.73 m2) or are receiving continuous renal replacement therapy, hemodialysis or peritoneal dialysis;
5. Individuals with malabsorption syndrome, or other conditions that affect gastrointestinal absorption, and circumstances in which patients need intravenous nutrition, or cannot take drugs orally or nasogastrically;
6. Pregnant or lactating women, or women with the potential to become pregnant during the study period and within 6 months after the end of administration;
7. Patients already included in other clinical trials;
8. Patient under treatment for HIV;
9. Patients being treated with other antivirals (eg lopinavir / ritonavir, remdesivir, umifenovir / arbidol, favipiravir, interferon-α)
10. Patients undergoing treatment with monoclonal antibodies (eg tocilizumab and sarilumab / kevzara);
11. Patients who are on a clinical treatment plan that includes the concomitant administration of any other experimental treatment or off-label use of drugs already on the market (eg hydroxychloroquine sulfate;
12. Patients who require invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO) at the time of randomization;
13. Any clinically significant medical condition or medical history that, in the investigator's opinion, might discourage participation in the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04668235
Study Brief:
Protocol Section:
NCT04668235