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
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
1,550
University of Malaya Medical Centre
Kuala Lumpur, Malaysia
NOT_YET_RECRUITINGInternational Islamic University Malaysia
Kuantan, Malaysia
NOT_YET_RECRUITINGALPS Medical Center
Shah Alam, Malaysia
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.
Time frame: Day 2 to Day 7
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Day 2 to Day 14
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Klinik Kesihatan Cheras
Shah Alam, Malaysia
NOT_YET_RECRUITINGKlinik Kesihatan Greentown
Shah Alam, Malaysia
NOT_YET_RECRUITINGKlinik Kesihatan Kuala Kedah
Shah Alam, Malaysia
NOT_YET_RECRUITINGKlinik Kesihatan Mahmoodiah
Shah Alam, Malaysia
NOT_YET_RECRUITINGCebu Doctors' University Hospitol
Cebu City, Philippines
RECRUITINGPerpetual Succour Hospital
Cebu City, Philippines
NOT_YET_RECRUITINGUniversity of the East Ramon Magsaysay Memorial Medical Center
Quezon City, Philippines
NOT_YET_RECRUITINGIncidence 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.
Time frame: 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.
Time frame: 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.
Time frame: Day 1 to Day 28
Duration of symptoms
Duration of symptoms in participants with COVID-19.
Time frame: Day 1 to Day 28
Adverse events
Number of participants with adverse events after administration of Azvudine will be evaluated.
Time frame: Day 1 to Day 28
Maximum serum concentration (Cmax)
The Cmax of Azvudine after administration in participants will be evaluated.
Time frame: Day 1 to Day 28
Time to reach maximum serum concentration (Tmax)
The Tmax of Azvudine after administration in participants will be evaluated.
Time frame: Day 1 to Day 28
Terminal half-life (T1/2)
The T1/2 of Azvudine after administration in participants will be evaluated.
Time frame: Day 1 to Day 28
Apparent total clearance (CL/F)
The CL/F of Azvudine after administration in participants will be evaluated.
Time frame: 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.
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)
The AUC0-t of Azvudine after administration in participants will be evaluated.
Time frame: 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.
Time frame: Day 1 to Day 28