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COVID-19Phase 3NCT05033145

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

A Phase 3 study testing AZVUDINE in people with COVID-19, run by HRH Pharmaceuticals Limited at 7 sites in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Phase III, single-center with co-participating units, randomized, double-blind, parallel, placebo-controlled clinical study Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
COVID-19
What is being tested?
AZVUDINE
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
312 participants
Where
7 sitesBrazil
Study dates
15 Jan 2022to 27 Jul 2022
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Individuals who present the following characteristics will be included in this study:
  • Age ≥18 years, regardless of gender;
  • Fluorescence RT-PCR test result of respiratory or blood samples must be positive for COVID-19, or viral gene sequencing of respiratory tract samples must be highly homologous to COVID-19; Individuals with COVID-19 must meet the diagnostic criteria in the "latest version of clinical guidelines for COVID-19" issued by the World Health Organization (WHO) on June 4, 2020;
  • Symptomatic patients who meet the case definition for COVID-19, according to WHO, without evidence of bacterial pneumonia or hypoxia (Sat O2 < 95%) P. [score 1-3];
  • Voluntary participation and signing of the informed consent form.

Who cannot join

  • Individuals who present one or more of the following characteristics will not be eligible to participate in this study:
  • Know or suspect that you are allergic to any of the components of AZVUDINE tablets (inactive ingredients: microcrystalline cellulose, lactose hydrate, polyvinylpyrrolidone K30, croscarmellose sodium, magnesium stearate);
  • Individual presenting shortness of breath and Sat O2 < 95%; or any other symptom requiring treatment through hospital admission;
  • Patients with liver disease (total bilirubin ≥2mg/dL, ALT/TGP e AST/TGO ≥5 times above normal limit);
  • Pactients with a history of known liver disease (cirrhosis with ChildPugh classification B and C);
  • Patients with a history of renal insufficiency (glomerular filtration rate < 60mL/min/1,73m2);
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  • Patients with history of congestive heart failure (NYHA ¾ grade), untreated symptomatic arrhythmias ormyocardial infarction within 6 months;
  • Individuals with malabsorption syndrome, or other conditions affecting gastrointestinal absorption, and circumstances in which patients require intravenous nutrition, or cannot take medications orally or nasogastrically;
  • Total neutrophil count <750 cells/L;

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

Brazil7 sites

  • Hospital Moacyr Gomes de Azevedo

    Cambuci, Rio de Janeiro

  • Clinical Research Unit / High Complexity Center (CRU/HCC) / Galzu Institute

    Campos dos Goytacazes, Rio de Janeiro, 28110-000

  • Hospital Santa Casa de Misericórdia de Campos

    Campos dos Goytacazes, Rio de Janeiro

  • Unidade de Pesquisa Clínica / Centro de Alta Complexidade

    Campos dos Goytacazes, Rio de Janeiro

  • Unidade Pré Hospitalar São José

    Campos dos Goytacazes, Rio de Janeiro

  • Hospital de Itaocara

    Itaocara, Rio de Janeiro

  • Hospital Armando Vidal

    São Fidelis, Rio de Janeiro

Other trials in Brazil

About this study

Official title: Evaluation of the Safety and Clinical Efficacy of AZVUDINE: Randomized, Double-blind, Placebo-controlled Study in Mild Stage Patients Infected With the SARS-CoV-2 Virus

Phase III, single-center with co-participating units, randomized, double-blind, parallel, placebo-controlled clinical study

Read the detailed description

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.

Conditions
COVID-19
Being tested
AZVUDINE, AZVUDINE placebo
Keywords
AZVUDINE, SARS-CoV-2, COVID-19, FNC
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AZVUDINEDrug

    Also called AZVUDINE 1 mg tablets, FNC, 4-amino-1-((2R,3S,4R,5R)-5-azido-3-fluoro-4-hydroxy-5-(hydroxymethyl)tetrahydrofuran-2-yl)pyrimidine-2(1H)-one, 1-(4-Azido-2-deoxy-2-fluoro-beta-D- arabino Ribo-furanosyl) cytosine, FNC

    AZVUDINE 5 tablets QD + standard treatment, for up to 14 days

  • AZVUDINE placeboDrug

    Also called Placebo

    5 tablets QD + standard treatment, for up to 14 days

Study groups in NCT05033145
Study groupRoleWhat they receive
AZVUDINEExperimentalExperimental: AZVUDINE 1mg tablet Interventions: AZVUDINE 1mg tablet, 5 tablets QD + standard treatment, for up to 14 days
Receives: Drug: AZVUDINE
AZVUDINE placeboPlacebo comparatorControl: AZVUDINE placebo Intervention: AZVUDINE placebo tablet, 5 tablets QD + standard treatment, for up to 14 days
Receives: Drug: AZVUDINE placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Day 14 to Day 30

  2. 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.

    Measured: Day 14 to Day 30

Secondary outcomes (13)

  1. Improvement in clinical status in at least one category compared to screening

    Ordinal Scale of Clinical Improvement (WHO, Jun/2020)

    Measured: Day 14 to Day 30

  2. 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)

    Measured: Day 1 to Day 14

  3. Changes in kidney function

    Change in urea/creatinine

    Measured: Day 1 to Day 30

  4. Changes in liver function

    Changes in ALT/AST

    Measured: Day 1 to Day 30

  5. 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.

    Measured: Day 1 to Day 14

  6. 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.

    Measured: Day 1 to Day 28

  7. Occurrence of drug interactions

    Monitoring of concomitant medication

    Measured: Day 1 to Day 14

  8. 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.

    Measured: Day 1 to Day 60

  9. All-cause mortality rate during the study

    mortality and its causes

    Measured: Day 1 to Day 60

  10. 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)

    Measured: Day 1 to Day 30

  11. Proportion of comorbidity-related worsening [Obesity, diabetes, alcoholism, smoking, lung disease]

    relationship between comorbidities and aggravations

    Measured: Day 1 to Day 30

  12. hospitalization for all causes occurring in post-treatment period

    hospitalization for all causes after treatment

    Measured: Day 1 to Day 60

  13. To assess the tolerability of using AZVUDINE (FNC) at 5mg/day

    calculation of participants who completed treatment

    Measured: Day 1 to Day 14

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Sep 2021
  2. Study start15 Jan 2022
  3. Primary completion27 Jul 2022
  4. Study completion27 Jul 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized, double-blind, parallel, placebo-controlled trial
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
312 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05033145
Sponsor's protocol ID
FNC IGZ-2
Status last verified
Sep 2021
First submitted
4 Dec 2020
Last updated
12 Aug 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • da Silva RM, Gebe Abreu Cabral P, de Souza SB, Arruda RF, Cabral SPF, de Assis ALEM, Martins YPM, Tavares CAA, Viana Junior AB, Chang J, Lei P. Serial viral load analysis by DDPCR to evaluate FNC efficacy and safety in the treatment of mild cases of COVID-19. Front Med (Lausanne). 2023 Mar 14;10:1143485. doi: 10.3389/fmed.2023.1143485. eCollection 2023.

    PubMed 37007788

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing AZVUDINE in people with COVID-19, run by HRH Pharmaceuticals Limited at 7 sites in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients hospitalized during the study through day 28 (time frame: Day 14 to Day 30). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05033145, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2022.

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Clinical Trial NCT05033145 | AzTrials