Phase III, single-center with co-participating units, randomized, double-blind, parallel, placebo-controlled clinical study
Hypothesis: AZVUDINE has a therapeutic potential and safety profile for the treatment of patients infected with SARS-CoV-2. Goals: Main goal: To evaluate the efficacy and safety of AZVUDINE (FNC) in patients infected with SARS-COV-2, in a mild stage; Specific objective: To assess the clinical outcome of mild-stage SARS-CoV-2 infected participants treated with AZVUDINE (FNC) versus placebo Statistical planning: Statistical description: all statistical tests are performed by bilateral testing. A significance level of 5% will be adopted. Baseline analysis: including subject distribution, data demographics, and baseline analysis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
312
AZVUDINE 5 tablets QD + standard treatment, for up to 14 days
5 tablets QD + standard treatment, for up to 14 days
Hospital Moacyr Gomes de Azevedo
Cambuci, Rio de Janeiro, Brazil
Clinical Research Unit / High Complexity Center (CRU/HCC) / Galzu Institute
Campos dos Goytacazes, Rio de Janeiro, Brazil
Hospital Santa Casa de Misericórdia de Campos
Campos dos Goytacazes, Rio de Janeiro, Brazil
Unidade de Pesquisa Clínica / Centro de Alta Complexidade
Proportion of patients hospitalized during the study through day 28
WHO clinical progression ordinal scale (Jun/2020), Score 4 to 10.Health Organization Ordinal Clinical Progression Scale (WHO, Jun/2020; scale 0 \[asymptomatic\] to 10 \[death\]), with score 4 to 7.
Time frame: Day 14 to Day 30
Proportion of participants with a clinical outcome of CURE during the study;
The clinical outcome of cure is defined in this protocol as the absence of viral RNA in samples collected and clinical conditions for outpatient discharge.
Time frame: Day 14 to Day 30
Improvement in clinical status in at least one category compared to screening
Ordinal Scale of Clinical Improvement (WHO, Jun/2020)
Time frame: Day 14 to Day 30
Severity and duration of symptoms: fever, cough, fatigue or tiredness, breathlessness, myalgia, nasal congestion or runny nose, sore throat, headache, chills, nausea, vomiting, anosmia, ageusia.
Intensity (1= Mild; 2= Moderate; 3= Severe; 4= Critical)
Time frame: Day 1 to Day 14
Changes in kidney function
Change in urea/creatinine
Time frame: Day 1 to Day 30
Changes in liver function
Changes in ALT/AST
Time frame: Day 1 to Day 30
Time of use of AZVUDINE until the second negative conversion of RT-PCR
Rate of change in biochemical markers of inflammatory function in relation to the physiological reference intervals between the AZVUDINA and PLACEBO groups.
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Campos dos Goytacazes, Rio de Janeiro, Brazil
Unidade Pré Hospitalar São José
Campos dos Goytacazes, Rio de Janeiro, Brazil
Hospital de Itaocara
Itaocara, Rio de Janeiro, Brazil
Hospital Armando Vidal
São Fidelis, Rio de Janeiro, Brazil
Time frame: Day 1 to Day 14
Evaluation of SARS-CoV-2 viral load negative conversion time by RT-PCR between AZVUDINE group (FNC) and control group
RT-PCR performed on treatment days.
Time frame: Day 1 to Day 28
Occurrence of drug interactions
Monitoring of concomitant medication
Time frame: Day 1 to Day 14
Assessment of liver function biochemical markers (AST/TGO, ALT/TGP, ALP, GGT, BIL total, and direct BIL)
Rate of change in biochemical markers of hepatic function in relation to the physiological reference intervals between the AZVUDINA and PLACEBO groups.
Time frame: Day 1 to Day 60
All-cause mortality rate during the study
mortality and its causes
Time frame: Day 1 to Day 60
Frequency and intensity of adverse events, unexpected adverse events, and serious adverse events
Intensity of adverse events (1= Mild; 2= Moderate; 3= Severe; 4= Critical)
Time frame: Day 1 to Day 30
Proportion of comorbidity-related worsening [Obesity, diabetes, alcoholism, smoking, lung disease]
relationship between comorbidities and aggravations
Time frame: Day 1 to Day 30
hospitalization for all causes occurring in post-treatment period
hospitalization for all causes after treatment
Time frame: Day 1 to Day 60
To assess the tolerability of using AZVUDINE (FNC) at 5mg/day
calculation of participants who completed treatment
Time frame: Day 1 to Day 14