COVID-19Phase 3NCT04668235
Study on Safety and Clinical Efficacy of AZVUDINE in COVID-19 Patients (SARS-CoV-2 Infected)
A Phase 3 study testing AZVUDINE in people with COVID-19, run by HRH Pharmaceuticals Limited at 1 site in Brazil.
Trial 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 drop in the number of hospitalizations and the cases of COPD, tuberculosis and HIV associated with COVID-19, which are… 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
- 180 participants
- Where
- 1 siteBrazil
- Study dates
- 23 Apr 2021to 10 Aug 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 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.
Who cannot join
- 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;
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Santa Casa de Misericordia de Campos
Campos dos Goytacazes, Rio de Janeiro
About this study
Official title: Evaluation of Safety and Clinical Efficacy of AZVUDINE in COVID-19 Patients (SARS-CoV-2 Infected): Phase III, Randomized, Double-blind, PLACEBO Controlled Trial
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 drop in the number of hospitalizations and the cases of COPD, tuberculosis and HIV associated with COVID-19, which are outside the inclusion criteria of this study. After the initial data of the study, there was a discussion with Anvisa and the size of the sample calculation was revised by amendment 4 (180 participants), and the methodology of statistical analysis for a new sample calculation was "a formula for sample calculation for superiority studies using proportions, according to the book do Chow et al (Chow, S.-C., Shao, J., Wang, H., \&Lokhnygina, Y. Eds. 2017. Sample Size Calculations in Clinical Research: Third Edition, Chapman and Hall/CRC). Thus, Anvisa concluded that the adjustments are in accordance with the agency's guidelines, approving E4, which was later also approved by the Ethics Committee.
Read the 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 (FNC) in relation to placebo, in patients infected with SARS-COV-2 in moderate to severe stage;
Secondary objective
- To evaluate the clinical outcome of the AZVUDINE group (FNC) compared to the placebo group in patients infected by SARS-COV-2 in moderate to severe stage;
Pharmaceutical form of the experimental medicine:
AZVUDINE 1 mg tablets
Comparators:
AZVUDINE placebo
Statistical planning:
The analyzes will be performed by FAS, PPS and SS and should be stratified by the severity of the disease (moderate, severe) and age (<60 years, ≥ 60 years), to assess the following parameters:
- Progression of the disease (moderate to severe, severe type);
- Negative viral load conversion rate;
- Time of negative conversion of viral load;
- Temperature recovery time;
- Time necessary to improve diarrhea, myalgia, fatigue, and other symptoms;
- Time to improve the pulmonary image;
- Frequency of supplemental oxygenation or non-invasive ventilation;
- Frequency of AEs;
- Mortality rate.
All statistical tests will be bilateral tests. If the P value is ≤0.05, it is considered that there is statistical significance between the difference in the tests.
- 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
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 group | Role | What they receive |
|---|---|---|
| Arm AZVUDINE | Experimental | Experimental:
AZVUDINE 1mg tablet,
Interventions:
AZVUDINE 1mg tablet, 5 tablets QD + standard treatment for up to 14 days Receives: Drug: AZVUDINE |
| Arm Placebo | Placebo comparator | Control:
AZVUDINE placebo,
Interventions:
AZVUDINE placebo, 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.
Evaluation of clinical improvement of AZVUDINE (FNC) in COVID-19 treatment
Rate of participants who reduced at least one level of the Clinical Progression Ordinal Scale category compared to the enrollment status (WHO, Jun/2020)
Measured: Day 1 to Day 15
Secondary outcomes (32)
Clinical cure outcome rate
Proportion of participants with clinical cure outcome during the study (viral RNA not detected and clinical conditions for discharge)
Measured: Day 1 to Day 15
Recovery of body temperature
Time (days) for normalization of body temperature (below 37.6℃ axillary)
Measured: Day 1 to Day 28
Clinical improvement of diarrhea, myalgia fatigue and other symptoms
Time (days) for clinical improvement of diarrhea, myalgia, fatigue, and other symptoms
Measured: Day 1 to Day 28
Assessment of inflammatory biochemical markers (Reactive C Protein, erythrocyte sedimentation rate, and Procalcitonin)
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 60
Assessment of immunological function biochemical markers (IL-6, IgG, IgM, IgA, and complement factor C3 and C4)
Rate of change in biochemical markers of immunological function in relation to the physiological reference intervals between the AZVUDINA and PLACEBO groups.
Measured: Day 1 to Day 60
Assessment of renal function biochemical markers (serum creatinine and calculated glomerular filtration rate)
Rate of change in biochemical markers of renal function in relation to the physiological reference intervals between the AZVUDINA and PLACEBO groups.
Measured: Day 1 to Day 60
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
Evaluation of time to negative conversion of SARS-CoV-2 viral load by RT-PCR
Time (days) to negative conversion of the SARS-CoV-2 viral load between AZVUDINE (FNC) and placebo group
Measured: Day 1 to Day 28
Evaluation of the number of cycles for the detection of SARS-CoV-2 viral load by RT-PCR and application of the standard curve for calculating viral load
SARS-CoV-2 viral load determination by standard-curve method of quantification
Measured: Day 1 to Day 15
Analysis of the relationship between the calculated viral load and the clinical evolution of the participants in the experimental group (FNC) and the PLACEBO group
Rating the relationship between viral load calculated and clinical outcomes of participants
Measured: Day 1 to Day 28
Time for improvement of pulmonary condition by imaging exams during treatment
Time (days) for pulmonary image improvement of: (1) Ground glass opacity pattern, (2) mosaic paving, (3) alveolar consolidation, (4) reticular pattern / septal thickening, (5) opaque with inverted halo, (6) pleural / pericardial effusion, (7) fibrosis and / or (8) lymphadenomegaly.
Measured: Day 1 to Day 28
Evaluation of pulmonary condition by imaging exams during treatment
Proportion of pulmonary image improvement of: (1) Ground glass opacity pattern, (2) mosaic paving, (3) alveolar consolidation, (4) reticular pattern / septal thickening, (5) opaque with inverted halo, (6) pleural / pericardial effusion, (7) fibrosis and / or (8) lymphadenomegaly.
Measured: Day 1 to Day 28
Time for clinical improvement of respiratory signs and symptoms
Time (days) for improvement in respiratory signs and symptoms during treatment (pulmonary rales, cough, sputum, or sore throat)
Measured: Day 1 to Day 28
Assessment of clinical improvement of respiratory signs and symptoms
Rate of improvement in respiratory signs and symptoms during treatment (pulmonary rales, cough, sputum, or sore throat)
Measured: Day 1 to Day 28
Time for normalization of O2 saturation
Time (days) to normalize O2 saturation (above 95%) between AZVUDINE (FNC) and placebo group
Measured: Day 1 to Day 28
Respiratory rate evaluation
Time (days) for respiratory rate normalization ≤24 rpm in room air
Measured: Day 1 to Day 28
Frequency of supplemental oxygenation or non-invasive ventilation
Frequency of supplemental oxygenation or non-invasive ventilation
Measured: Day 1 to Day 28
Frequency of invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO
Frequency of invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO
Measured: Day 1 to Day 28
Proportion of moderate cases that progressed to severe cases
Proportion of moderate cases that progressed to severe cases requiring care in an intensive care unit
Measured: Day 1 to Day 28
Assessment of hospitalization time
Length (days) of hospital stay
Measured: Day 1 to Day 28
Evaluation of drug interaction events frequency
Frequency of drug interaction events
Measured: Day 1 to Day 28
Evaluation of drug interaction events intensity
Intensity of drug interaction events (1= Mild; 2= Moderate; 3= Severe; 4= Critical)
Measured: Day 1 to Day 28
Assessment of adverse events frequency
Frequency of adverse events
Measured: Day 1 to Day 28
Assessment of adverse events intensity
Intensity of adverse events (1= Mild; 2= Moderate; 3= Severe; 4= Critical)
Measured: Day 1 to Day 28
Assessment of unexpected adverse events frequency
Frequency of unexpected adverse events
Measured: Day 1 to Day 28
Assessment of unexpected adverse events intensity
Intensity of unexpected adverse events (1= Mild; 2= Moderate; 3= Severe; 4= Critical)
Measured: Day 1 to Day 28
Assessment of serious adverse events frequency
Frequency of serious adverse events
Measured: Day 1 to Day 28
Assessment of serious adverse events intensity
Intensity of serious adverse events (1= Mild; 2= Moderate; 3= Severe; 4= Critical)
Measured: Day 1 to Day 28
Overall mortality rate
Mortality rate during the study
Measured: Day 1 to Day 28
Evaluation of the tolerability of azvudine in the 5 mg regimen orally QD up to 14 days
Treatment dropout rate due to AZVUDINE/Placebo intolerance.
Measured: Day 1 to Day 28
Assessment of adherence of azvudine in the 5 mg regimen orally QD up to 14 days
Medication possession rate, to measure the proportion of administered dose episodes observed in relation to the expected number of doses, until treatment interruption.
Measured: Day 1 to Day 28
Time of use of azvudine in the 5 mg regimen orally QD up to 14 days
Total time (days) of use of AZVUDINE / Placebo intolerance.
Measured: Day 1 to Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2020
- Study start23 Apr 2021
- Primary completion10 Aug 2022
- Study completion10 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- HRH Pharmaceuticals Limited
- Sponsor type
- University, hospital or other
- Collaborators
- GALZU INSTITUTE OF RESEARCH, TEACHING, SCIENCE AND APPLIED TECHNOLOGY, Brazil, UNIVERSIDADE ESTADUAL DO NORTE FLUMINENSE (UENF), Brazil
- Responsible party
- Sponsor
- Investigators
- Sheila P Figueiredo, MSc, Study director, Galzu Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04668235
- Sponsor's protocol ID
- FNC IGZ-1
- Status last verified
- Aug 2022
- 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
de Souza SB, Cabral PGA, da Silva RM, Arruda RF, Cabral SPF, de Assis ALEM, Viana Junior AB, Degrave WMS, Moreira ADS, Silva CG, Chang J, Lei P. Phase III, randomized, double-blind, placebo-controlled clinical study: a study on the safety and clinical efficacy of AZVUDINE in moderate COVID-19 patients. Front Med (Lausanne). 2023 Oct 19;10:1215916. doi: 10.3389/fmed.2023.1215916. eCollection 2023.
PubMed 37928473
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Safety and Clinical Efficacy of AZVUDINE in COVID-19 Patients (SARS-CoV-2 Infected): Phase III, Randomized, Double-blind, PLACEBO Controlled Trial
- ClinicalTrials.gov ID
- NCT04668235
- Acronym / sponsor ID
- FNC IGZ-1
- Conditions
- COVID-19
- Keywords
- AZVUDINE, SARS-CoV-2, COVID-19, FNC
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- HRH Pharmaceuticals LimitedUniversity, hospital or other
- Collaborators
- GALZU INSTITUTE OF RESEARCH, TEACHING, SCIENCE AND APPLIED TECHNOLOGY, Brazil, UNIVERSIDADE ESTADUAL DO NORTE FLUMINENSE (UENF), Brazil
- Study start
- 23 Apr 2021 (actual)
- Primary completion
- 10 Aug 2022 (actual)
- Study completion
- 10 Aug 2022 (actual)
- First posted
- 16 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 drop in the number of hospitalizations and the cases of COPD, tuberculosis and HIV associated with COVID-19, which are outside the inclusion criteria of this study. After the initial data of the study, there was a discussion with Anvisa and the size of the sample calculation was revised by amendment 4 (180 participants), and the methodology of statistical analysis for a new sample calculation was "a formula for sample calculation for superiority studies using proportions, according to the book do Chow et al (Chow, S.-C., Shao, J., Wang, H., \&Lokhnygina, Y. Eds. 2017. Sample Size Calculations in Clinical Research: Third Edition, Chapman and Hall/CRC). Thus, Anvisa concluded that the adjustments are in accordance with the agency's guidelines, approving E4, which was later also approved by the Ethics Committee.
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 (FNC) in relation to placebo, in patients infected with SARS-COV-2 in moderate to severe stage;
Secondary objective
- To evaluate the clinical outcome of the AZVUDINE group (FNC) compared to the placebo group in patients infected by SARS-COV-2 in moderate to severe stage;
Pharmaceutical form of the experimental medicine:
AZVUDINE 1 mg tablets
Comparators:
AZVUDINE placebo
Statistical planning:
The analyzes will be performed by FAS, PPS and SS and should be stratified by the severity of the disease (moderate, severe) and age (<60 years, ≥ 60 years), to assess the following parameters:
- Progression of the disease (moderate to severe, severe type);
- Negative viral load conversion rate;
- Time of negative conversion of viral load;
- Temperature recovery time;
- Time necessary to improve diarrhea, myalgia, fatigue, and other symptoms;
- Time to improve the pulmonary image;
- Frequency of supplemental oxygenation or non-invasive ventilation;
- Frequency of AEs;
- Mortality rate.
All statistical tests will be bilateral tests. If the P value is ≤0.05, it is considered that there is statistical significance between the difference in the tests.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm AZVUDINE | Experimental | Drug: AZVUDINEExperimental: AZVUDINE 1mg tablet, Interventions: AZVUDINE 1mg tablet, 5 tablets QD + standard treatment for up to 14 days |
| Arm Placebo | Placebo comparator | Drug: AZVUDINE placeboControl: AZVUDINE placebo, Interventions: AZVUDINE placebo, 5 tablets QD + standard treatment for up to 14 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (13 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AZVUDINEAlso: 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, FNC5 tablets QD + standard treatment for up to 14 days | Drug | Arm AZVUDINE |
| AZVUDINE placeboAlso: Placebo5 tablets QD + standard treatment for up to 14 days | Drug | Arm Placebo |
Primary outcome
Evaluation of clinical improvement of AZVUDINE (FNC) in COVID-19 treatment
Time frame: Day 1 to Day 15
Rate of participants who reduced at least one level of the Clinical Progression Ordinal Scale category compared to the enrollment status (WHO, Jun/2020)
32 secondary outcomes
Clinical cure outcome rate
Time frame: Day 1 to Day 15
Recovery of body temperature
Time frame: Day 1 to Day 28
Clinical improvement of diarrhea, myalgia fatigue and other symptoms
Time frame: Day 1 to Day 28
Assessment of inflammatory biochemical markers (Reactive C Protein, erythrocyte sedimentation rate, and Procalcitonin)
Time frame: Day 1 to Day 60
Assessment of immunological function biochemical markers (IL-6, IgG, IgM, IgA, and complement factor C3 and C4)
Time frame: Day 1 to Day 60
Assessment of renal function biochemical markers (serum creatinine and calculated glomerular filtration rate)
Time frame: Day 1 to Day 60
Assessment of liver function biochemical markers (AST/TGO, ALT/TGP, ALP, GGT, BIL total, and direct BIL)
Time frame: Day 1 to Day 60
Evaluation of time to negative conversion of SARS-CoV-2 viral load by RT-PCR
Time frame: Day 1 to Day 28
Evaluation of the number of cycles for the detection of SARS-CoV-2 viral load by RT-PCR and application of the standard curve for calculating viral load
Time frame: Day 1 to Day 15
Analysis of the relationship between the calculated viral load and the clinical evolution of the participants in the experimental group (FNC) and the PLACEBO group
Time frame: Day 1 to Day 28
Time for improvement of pulmonary condition by imaging exams during treatment
Time frame: Day 1 to Day 28
Evaluation of pulmonary condition by imaging exams during treatment
Time frame: Day 1 to Day 28
Time for clinical improvement of respiratory signs and symptoms
Time frame: Day 1 to Day 28
Assessment of clinical improvement of respiratory signs and symptoms
Time frame: Day 1 to Day 28
Time for normalization of O2 saturation
Time frame: Day 1 to Day 28
Respiratory rate evaluation
Time frame: Day 1 to Day 28
Frequency of supplemental oxygenation or non-invasive ventilation
Time frame: Day 1 to Day 28
Frequency of invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO
Time frame: Day 1 to Day 28
Proportion of moderate cases that progressed to severe cases
Time frame: Day 1 to Day 28
Assessment of hospitalization time
Time frame: Day 1 to Day 28
Evaluation of drug interaction events frequency
Time frame: Day 1 to Day 28
Evaluation of drug interaction events intensity
Time frame: Day 1 to Day 28
Assessment of adverse events frequency
Time frame: Day 1 to Day 28
Assessment of adverse events intensity
Time frame: Day 1 to Day 28
Assessment of unexpected adverse events frequency
Time frame: Day 1 to Day 28
Assessment of unexpected adverse events intensity
Time frame: Day 1 to Day 28
Assessment of serious adverse events frequency
Time frame: Day 1 to Day 28
Assessment of serious adverse events intensity
Time frame: Day 1 to Day 28
Overall mortality rate
Time frame: Day 1 to Day 28
Evaluation of the tolerability of azvudine in the 5 mg regimen orally QD up to 14 days
Time frame: Day 1 to Day 28
Assessment of adherence of azvudine in the 5 mg regimen orally QD up to 14 days
Time frame: Day 1 to Day 28
Time of use of azvudine in the 5 mg regimen orally QD up to 14 days
Time frame: Day 1 to Day 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2022.
- Derived from this study: PubMed 37928473de Souza SB, Cabral PGA, da Silva RM, Arruda RF, Cabral SPF, de Assis ALEM, Viana Junior AB, Degrave WMS, Moreira ADS, Silva CG, Chang J, Lei P. Phase III, randomized, double-blind, placebo-controlled clinical study: a study on the safety and clinical efficacy of AZVUDINE in moderate COVID-19 patients. Front Med (Lausanne). 2023 Oct 19;10:1215916. doi: 10.3389/fmed.2023.1215916. eCollection 2023.
- Individual participant dataSharing planned: No
Related trials for COVID-19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sheila P Figueiredo, MSc study director
Galzu Institute
1 site in 1 country: see every site and its status.
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 1 site 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 7 inclusion and 13 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 1 site 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?
Evaluation of clinical improvement of AZVUDINE (FNC) in COVID-19 treatment (time frame: Day 1 to Day 15). 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 NCT04668235, 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.