Study on Safety and Clinical Efficacy of AZVUDINE in COVID-19 Patients (SARS-CoV-2 Infected)

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Estimated number of participants: 342 participants with COVID-19 Design: Phase III, single-center, randomized, double-blind, parallel, placebo-controlled clinical study.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: HRH Holdngs Limited; HRH Pharmaceuticals Limited
• Collaborators: GALZU INSTITUTE OF RESEARCH, TEACHING, SCIENCE AND APPLIED TECHNOLOGY, Brazil; SANTA CASA DE MISERICORDIA DE CAMPOS HOSPITAL (SCMCH), Brazil; UNIVERSIDADE ESTADUAL DO NORTE FLUMINENSE (UENF), Brazil

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.