Status:
COMPLETED
Study on Safety and Clinical Efficacy of AZVUDINE in COVID-19 Patients (SARS-CoV-2 Infected)
Lead Sponsor:
HRH Pharmaceuticals Limited
Collaborating Sponsors:
GALZU INSTITUTE OF RESEARCH, TEACHING, SCIENCE AND APPLIED TECHNOLOGY, Brazil
UNIVERSIDADE ESTADUAL DO NORTE FLUMINENSE (UENF), Brazil
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Estimated number of participants: 342 participants with COVID-19 Design: Phase III, single-center, randomized, double-blind, parallel, placebo-controlled clinical study. In December 2021, there was a...
Detailed Description
Hypothesis: AZVUDINE has therapeutic potential and safety profile for the treatment of patients infected with SARS-CoV-2. Goals: Primary objective • To assess the efficacy and safety of AZVUDINE (F...
Eligibility Criteria
Inclusion
- Individuals aged 18 or over, regardless of gender;
- Patients hospitalized in moderate to severe stages in line with the Ministry of Health classification;
- 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;
- Time of onset of symptoms and inclusion ≤ 14 days;
- Internation within 48 hours after inclusion in the study;
- Follow-up availability during the study period;
- Voluntary membership to participate in the study and signing the Informed Consent Form.
Exclusion
- Patients known or suspected of being sensitive to AZVUDINE or excipients (inactive ingredients: microcrystalline cellulose, hydrated lactose, polyvinylpyrrolidone K30, croscarmellose sodium, magnesium stearate);
- Patients diagnosed with pneumonia caused by other pathogens;
- Patients with liver disease (total bilirubin ≥2 times above the normal limit, ALT / TGP and AST / TGO ≥5 times above the normal limit)
- Patients with renal failure (glomerular filtration rate ≤60mL / min / 1.73 m2) or are receiving continuous renal replacement therapy, hemodialysis or peritoneal dialysis;
- 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;
- 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;
- Patients already included in other clinical trials;
- Patient under treatment for HIV;
- Patients being treated with other antivirals (eg lopinavir / ritonavir, remdesivir, umifenovir / arbidol, favipiravir, interferon-α)
- Patients undergoing treatment with monoclonal antibodies (eg tocilizumab and sarilumab / kevzara);
- 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;
- Patients who require invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO) at the time of randomization;
- Any clinically significant medical condition or medical history that, in the investigator's opinion, might discourage participation in the study.
Key Trial Info
Start Date :
April 23 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 10 2022
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT04668235
Start Date
April 23 2021
End Date
August 10 2022
Last Update
August 12 2022
Active Locations (1)
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1
Santa Casa de Misericordia de Campos
Campos dos Goytacazes, Rio de Janeiro, Brazil