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

• Status: Not yet recruiting
• Trial end date: 2022-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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: Clinical Research Unit / High Complexity Center (CRU/HCC) / Galzu Institute; GALZU INSTITUTE OF RESEARCH, TEACHING, APPLIED SCIENCE AND TECHNOLOGY, Brazil; 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. Age ≥18 years, regardless of gender;

2. The result of the RT-PCR test by fluorescence of respiratory or blood samples must be positive for COVID-19, or the viral gene sequencing of respiratory tract samples must be highly homologous with COVID-19; Individuals with COVID-19 must meet the diagnostic criteria of the "latest version of the clinical guidelines for COVID-19" issued by the World Health Organization (WHO) on June 4th, 2020;

3. Symptomatic patients who meet the WHO case definition for COVID-19 with no evidence of bacterial pneumonia or hypoxia (Sat O2 <95%).

4. Voluntary participation and signing of the Informed Consent Form.

Exclusion Criteria:

1. Be aware or suspected of being allergic to any of the components of AZVUDINE tablets (inactive ingredients: microcrystalline cellulose, hydrated lactose, polyvinylpyrrolidone K30, croscarmellose sodium, magnesium stearate);

2. Individual with shortness of breath and Sat O2 < 95%; or any other symptom that requires treatment through hospitalization;

3. Patients with liver disease (total bilirubin ≥2mg/dL, ALT/TGP, and AST/TGO ≥5 times the normal limit);

4. Patients with a history of known liver disease (Chirrhosis, with ChildPugh classification B and C);

5. Patients with a history of renal failure (Glomerular Filtration Rate

6. Patients with a history of congestive heart failure (grade 3/4 NYHA), untreated symptomatic arrhythmias, or myocardial infarction for 6 months;

7. Individuals with malabsorption syndrome, or other conditions that affect gastrointestinal absorption, and circumstances in which patients require intravenous nutrition, or cannot take medications by mouth or nasogastric;

8. Total neutrophil count <750 cells/L;

9. Women who are pregnant or lactating, or of childbearing potential during the study period and within 6 months after termination of administration;

10. Individuals who have participated in another clinical trial and used an experimental drug in the past 12 weeks;

11. Patient actively being treated for HIV, Hepatitis C, or Hepatitis B;

12. Patients being treated with other antivirals (e.g., lopinavir/ritonavir, remdesivir, umifenovir/arbidol, favipiravir, interferon-α) or immunosuppressive drugs for other medical conditions;

13. Patients being treated with monoclonal antibodies (e.g., tocilizumab and sarilumab/kevzara);

14. Any clinically significant medical condition or medical history that, in the investigator's opinion, may discourage study participation, such as corrected QT interval >480 on the electrocardiogram, among other conditions.