SARS-CoV-2 InfectionPhase 2/3NCT05633433
Evaluate the Efficacy and Safety of Azvudine in Preventing SARS-Cov-2 Infection in Household Contacts of Covid-19
A Phase 2/3 study testing Azvudine in people with SARS-CoV-2 Infection, run by Shanghai Henlius Biotech at 10 sites in 2 countries.
Trial summary
A Phase II/III Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Azvudine in Preventing SARS-Cov-2 Infection in Household Contacts of Individuals Infected with SARS-CoV-2 Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- SARS-CoV-2 Infection
- What is being tested?
- Azvudine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,550 participants
- Where
- 10 sitesin 2 countries
- Study dates
- 29 Dec 2022to 15 Jul 2024
- Phase
- Phase 2/3
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ≥18 years old at the signing of informed consent.
- Household contacts of individual with symptomatic COVID-19. Symptomatic COVID-19 cases (index case) to be identified as those symptomatic and recently tested (rapid antigen test or RT-PCR) positive for SARS-CoV-2 and must fulfill the following criteria 1) collection of the first positive SARS-CoV-2 test sample less than 48 hours before randomization, 2) have at least one symptom attributable to COVID-19.
- RT-PCR test negative (with nasopharyngeal [NP] swab samples) OR rapid antigen test negative at the time of screening and without any suspicious COVID-19 symptoms within 2 weeks before randomization.
- Subject expects to be living in the same household with the symptomatic COVID-19 cases during the whole study period.
- Willing and able to comply with study visits and study-related procedures/assessments.
- Provide informed consent signed by study subject or legally acceptable representative.
Who cannot join
- Subject with a history of SARS-CoV-2 vaccinations within 6 months before randomization.
- Subject with a history of SARS-CoV-2 infection within 6 months before randomization.
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3×Upper Limit of Normal (ULN) ,or total bilirubin (TBIL) >2×ULN.
- Creatinine clearance (Ccr, calculated by Cockcroft-Gault equation)<60 ml/min or Creatinine >1.2×ULN.
- With any serious infection requiring systemic anti-infective therapy within 14 days before randomization.
- Allergic to the investigational agent or any components of the formulation.
Show all 10Show fewer
- Pregnant or breast-feeding women.
- Previous administration of any antiretroviral drugs (e.g., antiretroviral drugs for HIV, HBV, or HCV) within 7 days before randomization.
- Women of childbearing potential who are unwilling to practice highly effective contraception during the study, and for at least 6 months after the study; Sexually active men who are unwilling to use medically acceptable birth control during the study period.
- Have other conditions not suitable for inclusion as judged by the investigator.
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
Malaysia7 sites, 7 recruiting
- Not yet recruiting
University of Malaya Medical Centre
Kuala Lumpur
Mohd Idzwan bin Zakaria, Ph.D., 03-79493209 ext. 2251
Mohd Idzwan bin Zakaria, Ph.D.
- Not yet recruiting
International Islamic University Malaysia
Kuantan
Nur Syazwani Binti Jamhuri, Dr.
Nur Syazwani Binti Jamhuri, Dr.
- Not yet recruiting
ALPS Medical Center
Shah Alam
Benjamin George, Dr.
Benjamin George, Dr.
- Not yet recruiting
Klinik Kesihatan Cheras
Shah Alam
Siti Shafiatun Siti Shafiatun, Dr.
Siti Shafiatun Siti Shafiatun, Dr.
- Not yet recruiting
Klinik Kesihatan Greentown
Shah Alam
V. Paranthaman, Dr.
V. Paranthaman, Dr.
- Not yet recruiting
Klinik Kesihatan Kuala Kedah
Shah Alam
Fazlin Suhana Othman, Dr.
Fazlin Suhana Othman, Dr.
- Not yet recruiting
Klinik Kesihatan Mahmoodiah
Shah Alam
Wan Fadhilah Binti Wan Ismail, Dr.
Wan Fadhilah Binti Wan Ismail, Dr.
Philippines3 sites, 3 recruiting
- Recruiting
Cebu Doctors' University Hospitol
Cebu City
Gerard S. Garcia, M.D.
Gerard S. Garcia, M.D.
- Not yet recruiting
Perpetual Succour Hospital
Cebu City
Jemela Anne Sanchez, Dr.
Jemela Anne Sanchez, Dr.
- Not yet recruiting
University of the East Ramon Magsaysay Memorial Medical Center
Quezon City
Nina Marnie Beltran-Yap, M.D.
Nina Marnie Beltran-Yap, M.D.
About this study
Official title: A Phase II/III Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Azvudine in Preventing SARS-Cov-2 Infection in Household Contacts of Individuals Infected With SARS-CoV-2
A Phase II/III Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Azvudine in Preventing SARS-Cov-2 Infection in Household Contacts of Individuals Infected with SARS-CoV-2
Read the detailed description
The study has two parts:
Part 1 is a multicentre, randomized, double-blind, placebo-controlled phase II clinical study to evaluate the efficacy and safety of Azvudine versus placebo in preventing SARS-CoV-2 infection in household contacts with SARS-CoV-2 infection individuals. The population of part 1 will consist of approximately 450 adults with household contact exposure to individuals with a confirmed SARS-CoV-2 infection.A phase III study will be further conducted if any of the treatment groups reduce SARS-CoV-2 infection rate (Relative risk reduction) > 50% compared with the placebo group.
Part 2 is a multicentre, randomized, double-blind, placebo-controlled phase III clinical study. The subject sample size will be calculated based on the results of the Phase II trial.
Phase II and phase III studies have the same objectives and primary/secondary end points. The primary endpoint is the proportion of subjects with positive SARS-CoV-2 RT-PCR assay in 7 days. Nasopharyngeal swabs will be collected at D2, D4, D7, D10, and D14 by RT-PCR to confirm SARS-CoV-2 infection.
- Conditions
- SARS-CoV-2 Infection
- Being tested
- Azvudine, Placebo
- 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 FNC
Azvudine is a novel nucleoside reverse transcriptase inhibitor.
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| cohort A （Phase II） | Experimental | Azvudine 5 mg, QD PO, D1-D7 Receives: Drug: Azvudine |
| cohort B （Phase II） | Experimental | Azvudine 3 mg + placebo 2 mg, QD PO, D1-D7 Receives: Drug: Azvudine; Drug: Placebo |
| cohort C （Phase II） | Placebo comparator | placebo 5 mg, QD PO, D1-D7 Receives: Drug: Placebo |
| Arm 1 (Phase III) | Experimental | Azvudine, dose to be determined according to phase II, QD PO, D1-D7 Receives: Drug: Azvudine |
| Arm 2 (Phase III) | Placebo comparator | Placebo, dose to be the same as Arm1, QD PO, D1-D7 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy-Incidence of SARS-CoV-2 infection in 7 days
The incidence of SARS-CoV-2 infection (RT-PCR positive) up to 7 days from 2 days after administration of Azvudine for prevention of SARS-CoV-2 infection.
Measured: Day 2 to Day 7
Secondary outcomes (17)
Incidence of asymptomatic SARS-CoV-2 infection in 7 days
The incidence of asymptomatic SARS-CoV-2 infection (RT-PCR positive) up to 7 days from 2 days after administration of Azvudine for prevention of SARS-CoV-2 infection.
Measured: Day 2 to Day 7
Incidence of symptomatic SARS-CoV-2 infection in 7 days
The incidence of symptomatic SARS-CoV-2 infection (RT-PCR positive) up to 7 days from 2 days after administration of Azvudine for prevention of SARS-CoV-2 infection.
Measured: Day 2 to Day 7
Incidence of SARS-CoV-2 infection in 14 days
The incidence of SARS-CoV-2 infection (RT-PCR positive) up to 14 days from 2 days after administration of Azvudine for prevention of SARS-CoV-2 infection.
Measured: Day 2 to Day 14
Incidence of asymptomatic SARS-CoV-2 infection in 14 days
The incidence of asymptomatic SARS-CoV-2 infection (RT-PCR positive) up to 14 days from 2 days after administration of Azvudine for prevention of SARS-CoV-2 infection.
Measured: Day 2 to Day 14
Incidence of symptomatic SARS-CoV-2 infection in 14 days
The incidence of SARS-CoV-2 infection (RT-PCR positive) up to 14 days from 2 days after administration of Azvudine for prevention of SARS-CoV-2 infection.
Measured: Day 2 to Day 14
Incidence of severe COVID-19
To describe the incidence of severe COVID-19 up to 28 days after administration of Azvudine for prevention of SARS-CoV-2 infection.
Measured: Day 1 to Day 28
Incidence of all-cause mortality
To describe the incidence of all-cause mortality during the 28 days after administration of Azvudine for prevention of SAR-CoV-2 infection.
Measured: Day 1 to Day 28
Time to SARS-CoV-2 infection
The time to SARS-CoV-2 infection after the the first dose of Azvudine will be evaluated in the RT-PCR positive participants.
Measured: Day 1 to Day 28
Duration of symptoms
Duration of symptoms in participants with COVID-19.
Measured: Day 1 to Day 28
Adverse events
Number of participants with adverse events after administration of Azvudine will be evaluated.
Measured: Day 1 to Day 28
Maximum serum concentration (Cmax)
The Cmax of Azvudine after administration in participants will be evaluated.
Measured: Day 1 to Day 28
Time to reach maximum serum concentration (Tmax)
The Tmax of Azvudine after administration in participants will be evaluated.
Measured: Day 1 to Day 28
Terminal half-life (T1/2)
The T1/2 of Azvudine after administration in participants will be evaluated.
Measured: Day 1 to Day 28
Apparent total clearance (CL/F)
The CL/F of Azvudine after administration in participants will be evaluated.
Measured: Day 1 to Day 28
Apparent volume of distribution based on terminal phase (Vz/F)
The Vz/F of Azvudine after administration in participants will be evaluated.
Measured: Day 1 to Day 28
Area under the concentration-time curve from time 0 to the last concentration-measurable time point (AUC0-t)
The AUC0-t of Azvudine after administration in participants will be evaluated.
Measured: Day 1 to Day 28
Area under the concentration-time curve from time 0 to infinity (AUC0-∞)
The AUC0-∞ of Azvudine after administration in participants will be evaluated.
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 posted1 Dec 2022
- Study start29 Dec 2022
- Primary completion15 Jun 2024 (estimated)
- Study completion15 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV-2 InfectionStudies of the same condition, open and under way.
- More trials run by Shanghai Henlius BiotechThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,550 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Henlius Biotech
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd., Henan Genuine Biotech Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Gerard S. Garcia, M.D., Principal investigator, Cebu Doctor's University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05633433
- Sponsor's protocol ID
- FNC-Covid304
- Status last verified
- Jan 2023
- First submitted
- 30 Nov 2022
- Last updated
- 9 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II/III Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Azvudine in Preventing SARS-Cov-2 Infection in Household Contacts of Individuals Infected With SARS-CoV-2
- ClinicalTrials.gov ID
- NCT05633433
- Acronym / sponsor ID
- FNC-Covid304
- Conditions
- SARS-CoV-2 Infection
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,550 participants (estimated)
- Lead sponsor
- Shanghai Henlius BiotechIndustry (pharma, biotech, devices)
- Collaborators
- Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd., Henan Genuine Biotech Co., Ltd.
- Study start
- 29 Dec 2022 (actual)
- Primary completion
- 15 Jun 2024 (estimated)
- Study completion
- 15 Jul 2024 (estimated)
- First posted
- 1 Dec 2022 (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.
A Phase II/III Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Azvudine in Preventing SARS-Cov-2 Infection in Household Contacts of Individuals Infected with SARS-CoV-2
Detailed description
The study has two parts:
Part 1 is a multicentre, randomized, double-blind, placebo-controlled phase II clinical study to evaluate the efficacy and safety of Azvudine versus placebo in preventing SARS-CoV-2 infection in household contacts with SARS-CoV-2 infection individuals. The population of part 1 will consist of approximately 450 adults with household contact exposure to individuals with a confirmed SARS-CoV-2 infection.A phase III study will be further conducted if any of the treatment groups reduce SARS-CoV-2 infection rate (Relative risk reduction) > 50% compared with the placebo group.
Part 2 is a multicentre, randomized, double-blind, placebo-controlled phase III clinical study. The subject sample size will be calculated based on the results of the Phase II trial.
Phase II and phase III studies have the same objectives and primary/secondary end points. The primary endpoint is the proportion of subjects with positive SARS-CoV-2 RT-PCR assay in 7 days. Nasopharyngeal swabs will be collected at D2, D4, D7, D10, and D14 by RT-PCR to confirm SARS-CoV-2 infection.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| cohort A （Phase II） | Experimental | Drug: AzvudineAzvudine 5 mg, QD PO, D1-D7 |
| cohort B （Phase II） | Experimental | Drug: Azvudine, Drug: PlaceboAzvudine 3 mg + placebo 2 mg, QD PO, D1-D7 |
| cohort C （Phase II） | Placebo comparator | Drug: Placeboplacebo 5 mg, QD PO, D1-D7 |
| Arm 1 (Phase III) | Experimental | Drug: AzvudineAzvudine, dose to be determined according to phase II, QD PO, D1-D7 |
| Arm 2 (Phase III) | Placebo comparator | Drug: PlaceboPlacebo, dose to be the same as Arm1, QD PO, D1-D7 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ≥18 years old at the signing of informed consent.
- Household contacts of individual with symptomatic COVID-19. Symptomatic COVID-19 cases (index case) to be identified as those symptomatic and recently tested (rapid antigen test or RT-PCR) positive for SARS-CoV-2 and must fulfill the following criteria 1) collection of the first positive SARS-CoV-2 test sample less than 48 hours before randomization, 2) have at least one symptom attributable to COVID-19.
- RT-PCR test negative (with nasopharyngeal [NP] swab samples) OR rapid antigen test negative at the time of screening and without any suspicious COVID-19 symptoms within 2 weeks before randomization.
- Subject expects to be living in the same household with the symptomatic COVID-19 cases during the whole study period.
- Willing and able to comply with study visits and study-related procedures/assessments.
Key exclusion criteria (10 listed)
- Subject with a history of SARS-CoV-2 vaccinations within 6 months before randomization.
- Subject with a history of SARS-CoV-2 infection within 6 months before randomization.
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3×Upper Limit of Normal (ULN) ,or total bilirubin (TBIL) >2×ULN.
- Creatinine clearance (Ccr, calculated by Cockcroft-Gault equation)<60 ml/min or Creatinine >1.2×ULN.
- With any serious infection requiring systemic anti-infective therapy within 14 days before randomization.
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: FNCAzvudine is a novel nucleoside reverse transcriptase inhibitor. | Drug | Arm 1 (Phase III), cohort A （Phase II）, cohort B （Phase II） |
| PlaceboPlacebo | Drug | Arm 2 (Phase III), cohort B （Phase II）, cohort C （Phase II） |
Primary outcome
Efficacy-Incidence of SARS-CoV-2 infection in 7 days
Time frame: Day 2 to Day 7
The incidence of SARS-CoV-2 infection (RT-PCR positive) up to 7 days from 2 days after administration of Azvudine for prevention of SARS-CoV-2 infection.
17 secondary outcomes
Incidence of asymptomatic SARS-CoV-2 infection in 7 days
Time frame: Day 2 to Day 7
Incidence of symptomatic SARS-CoV-2 infection in 7 days
Time frame: Day 2 to Day 7
Incidence of SARS-CoV-2 infection in 14 days
Time frame: Day 2 to Day 14
Incidence of asymptomatic SARS-CoV-2 infection in 14 days
Time frame: Day 2 to Day 14
Incidence of symptomatic SARS-CoV-2 infection in 14 days
Time frame: Day 2 to Day 14
Incidence of severe COVID-19
Time frame: Day 1 to Day 28
Incidence of all-cause mortality
Time frame: Day 1 to Day 28
Time to SARS-CoV-2 infection
Time frame: Day 1 to Day 28
Duration of symptoms
Time frame: Day 1 to Day 28
Adverse events
Time frame: Day 1 to Day 28
Maximum serum concentration (Cmax)
Time frame: Day 1 to Day 28
Time to reach maximum serum concentration (Tmax)
Time frame: Day 1 to Day 28
Terminal half-life (T1/2)
Time frame: Day 1 to Day 28
Apparent total clearance (CL/F)
Time frame: Day 1 to Day 28
Apparent volume of distribution based on terminal phase (Vz/F)
Time frame: Day 1 to Day 28
Area under the concentration-time curve from time 0 to the last concentration-measurable time point (AUC0-t)
Time frame: Day 1 to Day 28
Area under the concentration-time curve from time 0 to infinity (AUC0-∞)
Time frame: Day 1 to Day 28
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2023.
- Individual participant dataSharing planned: No
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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.
Gerard S. Garcia, M.D. principal investigator
Cebu Doctor's University Hospital
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Azvudine in people with SARS-CoV-2 Infection, run by Shanghai Henlius Biotech at 10 sites in 2 countries.
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 6 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 9 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Malaysia, Philippines. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gerard S. Garcia, M.D. (+63324169341, cduhrec@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy-Incidence of SARS-CoV-2 infection in 7 days (time frame: Day 2 to Day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jan 2023.