SARS-CoV-2 InfectionNCT05642910
The Efficacy of Azvudine and Paxlovid in High-risk Patients With COVID-19: A Prospective Randomized Controlled Trial
A study testing Azvudine and Paxlovid group in people with SARS-CoV-2 Infection, run by Southeast University, China at 1 site in China.
Trial summary
This is a randomized controlled clinical study on the clinical efficacy of Azvudine and Paxlovid antivirus therapy in COVID-19 patients with high-risk. The objective is to examine the effect of high-risk on the time for COVID-19 patients to achieve 2 continuously negative SARS-CoV-2 nucleic acid test result, and the… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- SARS-CoV-2 Infection
- What is being tested?
- Azvudine and Paxlovid group
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 540 participants
- Where
- 1 siteChina
- Study dates
- 18 Oct 2022to 30 Apr 2023
- Phase
- Interventional
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18-85 years (inclusive).
- Meet the diagnostic criteria for COVID-19.
- At least one high risk factor for progression to severe COVID-19
- No more than 5 days from the onset of clinical symptoms
- Sign informed consent form.
Who cannot join
- Severe or critically patients with COVID-19
- Have received neutralizing antibodies or convalescent plasma therapy due to COVID-19
- Child-Pugh grade C or acute liver failure
- Chronic renal failure (eGFR<30 mL/min)
- Grade III or IV cardiac function, or known left ventricular ejection fraction < 30%
- Known or suspected history of active or extrapulmonary tuberculosis
- Patients who are allergic to the active ingredient of the drug
- Pregnant and lactating women
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Hohhot First Hospital
Hohhot, Inner Mongolia, 010031
Junjing Zhang, Dr, 086-04175281618, zhang.jj@vip.163.com
About this study
This is a randomized controlled clinical study on the clinical efficacy of Azvudine and Paxlovid antivirus therapy in COVID-19 patients with high-risk. The objective is to examine the effect of high-risk on the time for COVID-19 patients to achieve 2 continuously negative SARS-CoV-2 nucleic acid test result, and the RT-PCR negative conversion rates in day 7. Patients who meet inclusion criteria will be randomized into the Azvudine group (treatment group) and Paxlovid group (control group).
Read the detailed description
After enrollment, patients will be randomized into treatment or control groups. Patients received Azvudine orally, for 7 consecutive days (7 doses in total) or Paxlovid orally for 5 consecutive days (10 doses in total). The test for RT-PCR test through either nasopharyngeal or oropharyngeal swabs were conducted on a daily basis from day 3 of their hospitalization until conversion was observed. The primary outcome was the proportion of patients acheive 2 continuously RT-PCR negative for SARS-CoV-2 at 7 days following treatment initiation, including both ORF gene Ct value≥35 and N gene Ct value≥35. Secondary outcomes included 1) the proportion of patients RT-PCR negative for SARS-CoV-2 at 14 days; 2) the time to conversion from a positive RT-PCR test to 2 continuously negative test; 3) 14-day treatment failure rate (need mechanical ventilation or high-flow oxygen therapy or death).
- Conditions
- SARS-CoV-2 Infection
- Being tested
- Azvudine, Paxlovid group
- Keywords
- SARS-CoV-2, antivirus, COVID-19
- 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 treatment group
Patients received Azvudine orally, for 7 consecutive days (7 doses in total)
Paxlovid groupDrug
Also called control group
Patients received Paxlovid orally for 5 consecutive days (10 doses in total).
| Study group | Role | What they receive |
|---|---|---|
| Azvudine group | Experimental | Patients received Azvudine orally, for 7 consecutive days (7 doses in total) . Receives: Drug: Azvudine |
| Paxlovid group | Active comparator | Patients received Paxlovid orally for 5 consecutive days (10 doses in total). Receives: Drug: Paxlovid group |
What is being measured
The primary outcome is the main question the study is designed to answer.
the proportion of patients RT-PCR negative for SARS-CoV-2 at 7 days
the proportion of patients RT-PCR negative for SARS-CoV-2 at 7 days
Measured: 7 days after enrolled
Secondary outcomes (2)
the proportion of patients RT-PCR negative for SARS-CoV-2 at 14 days
the proportion of patients RT-PCR negative for SARS-CoV-2 at 14 days
Measured: 14 days
the time to conversion from a positive RT-PCR test to 2 continuously negative test
the time to conversion from a positive RT-PCR test to 2 continuously negative test
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2022
- Study start18 Oct 2022
- Primary completion31 Jan 2023 (estimated)
- Study completion30 Apr 2023 (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.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients who meet inclusion criteria will be randomized into the Azvudine group (treatment group) and Paxlovid group (control group).
- Masking
- None (open label)
- Enrolment
- 540 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southeast University, China
- Sponsor type
- University, hospital or other
- Collaborators
- Hohhot First Hospital, Hohhot, Inner Mongolia, China
- Responsible party
- Principal investigator, Songqiao Liu, Southeast University, China
- Investigators
- Songqiao Liu, MD. PhD., Principal investigator, Southeast university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05642910
- Sponsor's protocol ID
- IBR2022072
- Status last verified
- Dec 2022
- First submitted
- 7 Dec 2022
- Last updated
- 8 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We did not seek or receive approval for this data sharing from our Institutional Review Board .
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Azvudine and Paxlovid in High-risk Patients With COVID-19: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05642910
- Acronym / sponsor ID
- IBR2022072
- Conditions
- SARS-CoV-2 Infection
- Keywords
- SARS-CoV-2, antivirus, COVID-19
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 540 participants (estimated)
- Lead sponsor
- Southeast University, ChinaUniversity, hospital or other
- Collaborators
- Hohhot First Hospital, Hohhot, Inner Mongolia, China
- Study start
- 18 Oct 2022 (actual)
- Primary completion
- 31 Jan 2023 (estimated)
- Study completion
- 30 Apr 2023 (estimated)
- First posted
- 8 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.
This is a randomized controlled clinical study on the clinical efficacy of Azvudine and Paxlovid antivirus therapy in COVID-19 patients with high-risk. The objective is to examine the effect of high-risk on the time for COVID-19 patients to achieve 2 continuously negative SARS-CoV-2 nucleic acid test result, and the RT-PCR negative conversion rates in day 7. Patients who meet inclusion criteria will be randomized into the Azvudine group (treatment group) and Paxlovid group (control group).
Detailed description
After enrollment, patients will be randomized into treatment or control groups. Patients received Azvudine orally, for 7 consecutive days (7 doses in total) or Paxlovid orally for 5 consecutive days (10 doses in total). The test for RT-PCR test through either nasopharyngeal or oropharyngeal swabs were conducted on a daily basis from day 3 of their hospitalization until conversion was observed. The primary outcome was the proportion of patients acheive 2 continuously RT-PCR negative for SARS-CoV-2 at 7 days following treatment initiation, including both ORF gene Ct value≥35 and N gene Ct value≥35. Secondary outcomes included 1) the proportion of patients RT-PCR negative for SARS-CoV-2 at 14 days; 2) the time to conversion from a positive RT-PCR test to 2 continuously negative test; 3) 14-day treatment failure rate (need mechanical ventilation or high-flow oxygen therapy or death).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients who meet inclusion criteria will be randomized into the Azvudine group (treatment group) and Paxlovid group (control group).
| Arm | Type | Receives |
|---|---|---|
| Azvudine group | Experimental | Drug: AzvudinePatients received Azvudine orally, for 7 consecutive days (7 doses in total) . |
| Paxlovid group | Active comparator | Drug: Paxlovid groupPatients received Paxlovid orally for 5 consecutive days (10 doses in total). |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients aged 18-85 years (inclusive).
- Meet the diagnostic criteria for COVID-19.
- At least one high risk factor for progression to severe COVID-19
- No more than 5 days from the onset of clinical symptoms
- Sign informed consent form.
Key exclusion criteria (8 listed)
- Severe or critically patients with COVID-19
- Have received neutralizing antibodies or convalescent plasma therapy due to COVID-19
- Child-Pugh grade C or acute liver failure
- Chronic renal failure (eGFR<30 mL/min)
- Grade III or IV cardiac function, or known left ventricular ejection fraction < 30%
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: treatment groupPatients received Azvudine orally, for 7 consecutive days (7 doses in total) | Drug | Azvudine group |
| Paxlovid groupAlso: control groupPatients received Paxlovid orally for 5 consecutive days (10 doses in total). | Drug | Paxlovid group |
Primary outcome
the proportion of patients RT-PCR negative for SARS-CoV-2 at 7 days
Time frame: 7 days after enrolled
the proportion of patients RT-PCR negative for SARS-CoV-2 at 7 days
2 secondary outcomes
the proportion of patients RT-PCR negative for SARS-CoV-2 at 14 days
Time frame: 14 days
the time to conversion from a positive RT-PCR test to 2 continuously negative test
Time frame: 14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2022.
- Individual participant dataSharing planned: No. We did not seek or receive approval for this data sharing from our Institutional Review Board .
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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.
Songqiao Liu, MD. PhD. principal investigator
Southeast university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Azvudine and Paxlovid group in people with SARS-CoV-2 Infection, run by Southeast University, China at 1 site in China.
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 8 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 8 Dec 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 China. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 Songqiao Liu, MD. PhD. (086-13770723635, liusongqiao@ymail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the proportion of patients RT-PCR negative for SARS-CoV-2 at 7 days (time frame: 7 days after enrolled). 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 8 Dec 2022.