COVID-19Phase 4NCT05697055
A Study of Efficacy and Safety of Azvudine vs. Nirmatrelvir-Ritonavir in the Treatment of COVID-19 Infection
A Phase 4 study testing Azvudine and Nirmatrelvir-Ritonavir in people with COVID-19, run by Shandong Provincial Hospital at 1 site in China.
Trial summary
The COVID-19 pandemic has become a major public health challenge, and the treatment options for the disease are currently limited. The commonly used oral small-molecule anti-COVID-19 drugs in China are Nirmatrelvir-Ritonavir and Azvudine. 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 and Nirmatrelvir-Ritonavir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 410 participants
- Where
- 1 siteChina
- Study dates
- 21 Jan 2023to 21 Jul 2023
- Phase
- Phase 4
- 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
- Hospitalized patients of ≥18 years old, regardless of gender or race;
- Patients who have a positive SARS-CoV-2 test result;
- Diagnosed with moderate or severe COVID-19 infection according to the diagnostic criteria from the "Diagnosis and treatment program trial version 10 guidelines" issued by the National Health Commission of the People's Republic of China. Including:
- ①Moderate: continuous high fever for more than 3 days or/and cough, shortness of breath, etc., but the breathing frequency (RR) is less than 30 times/minute, and the oxygen saturation when inhaling air at rest is > 93%. Imaging shows the characteristic manifestations of COVID-19 pneumonia.
- ② Severe: Adults meet any of the following requirements: A, shortness of breath, RR≥ 30 times/minute; B, the oxygen saturation when inhaling air at rest is ≤ 93%; C, Arterial partial oxygen pressure (PaO2)/ Fraction of inspiration O2 (FiO2) ≤300mmHg (1mmHg=0.133kPa), and PaO2/FiO2 should be corrected according to the following formula for areas above 1000 m :PaO2/FiO2× [760/ atmospheric pressure (mmHg)]; D, the clinical symptoms were gradually aggravated, and the lung imaging showed that the lesion progressed significantly within 24 ~ 48 hours > 50%.
- Join this study voluntarily.
- Each subject must sign an informed consent form (ICF) indicating that he/she understands the purpose and procedure of the study and is willing to participate in the study. Considering the patient's condition, the ICF may be signed by the legal representative.
Who cannot join
- Allergic to the drugs involved;
- Pregnancy or lactation;
- Diagnosed or suspected critical COVID-19 infection;
- Child-Pugh C of liver function or estimated glomerular filtration rate (eGFR) less than 30mL/min during screening;
- Receive SARS-CoV-2 monoclonal antibody therapy or other antiviral therapy;
- The subject and/or authorized family members refused to receive anti-COVID-19 treatment;
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- Any life-threatening disease or organ system dysfunction that the researcher thinks can harm the safety of the subjects and expose the research results to unnecessary risks; drug addicts, uncontrolled mental illness or cognitive dysfunction.
- Join other similar clinical researchers within 3 months;
- Patients who were not considered suitable for inclusion by the researchers (such as patients who were expected to be unable to adhere to the treatment due to financial problems).
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shandong Provincial Hospital
Jinan, Shandong
About this study
Official title: A Prospective Multicenter, Randomized, Controlled Clinical Trial of the Safety and Efficacy of Azvudine vs. Nirmatrelvir-Ritonavir in Hospitalized Patients With Moderate to Severe COVID-19 Infection
The COVID-19 pandemic has become a major public health challenge, and the treatment options for the disease are currently limited. The commonly used oral small-molecule anti-COVID-19 drugs in China are Nirmatrelvir-Ritonavir and Azvudine. These drugs have been tested in pre-marketing clinical trials in patients with non-severe COVID-19 infection and have demonstrated therapeutic effects in inhibiting virus transmission and preventing disease progression. However, until now, the efficacy and safety of these drugs in patients with moderate to severe COVID-19 infections remains unclear. Therefore, this study is aiming to compare the efficacy and safety of Azvudine and Nirmatrelvir-Ritonavir in moderate to severe COVID-19 infections. This study will be a multicenter, randomized, controlled clinical trial study in patients hospitalized with moderate to severe COVID-19 infections. Recovery of clinical symptoms, nucleic acid negative conversion, improvement in oxygenation index, and imaging improvement will be used as study endpoints.
- Conditions
- COVID-19
- Being tested
- Azvudine, Nirmatrelvir-Ritonavir
- Keywords
- COVID-19, Azvudine, Nirmatrelvir-Ritonavir, Efficacy, Safety
- 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
5mg orally, once a day, for no more than 14 days
Nirmatrelvir-RitonavirDrug
Nirmatrelvir 300mg combined with Ritonavir 100mg every 12 hours for 5 days. For patients with 30≤ eGFR < 60 ml/min, it should be reduced to150mg/100mg Nirmatrelvir-Ritonavir every 12 hours for 5 days
| Study group | Role | What they receive |
|---|---|---|
| Azvudine | Experimental | Not described Receives: Drug: Azvudine |
| Nirmatrelvir-Ritonavir | Active comparator | Not described Receives: Drug: Nirmatrelvir-Ritonavir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time and proportion of patients with COVID-19 infection to have sustained clinical recovery
Measured: Up to 28 days
Secondary outcomes (6)
Proportion of progression to critical COVID-19 and death from any cause
Measured: Up to 28 days
Time of COVID-19 related symptom score and World Health Organization (WHO) clinical progress scale score. Time and proportion of clinical recovery, symptom resolution and regression of major symptoms
Measured: Up to 28 days
Time and proportion of the nucleic acid negative conversion
Measured: Days 3, 6, 9, 12, 15, 18, 21, 24, 27
Time and proportion of chest CT image improvement
Measured: Days 6, 12, 18, 24
Time and proportion of oxygenation index improvement
Measured: Up to 28 days
Length of stay
Measured: Up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2023
- Study start21 Jan 2023
- Primary completion21 May 2023 (estimated)
- Study completion21 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 410 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong Provincial Hospital
- Sponsor type
- Other government
- Collaborators
- Qianfoshan Hospital, The Second Affiliated Hospital of Shandong First Medical University, The Affiliated Hospital Of Southwest Medical University, Gansu Provincial Hospital, Rizhao People's Hospital
- Responsible party
- Principal investigator, Jia-jun Zhao, Shandong Provincial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05697055
- Sponsor's protocol ID
- SWYX2023022
- Status last verified
- Feb 2023
- First submitted
- 20 Jan 2023
- Last updated
- 27 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multicenter, Randomized, Controlled Clinical Trial of the Safety and Efficacy of Azvudine vs. Nirmatrelvir-Ritonavir in Hospitalized Patients With Moderate to Severe COVID-19 Infection
- ClinicalTrials.gov ID
- NCT05697055
- Acronym / sponsor ID
- SWYX2023022
- Conditions
- COVID-19
- Keywords
- COVID-19, Azvudine, Nirmatrelvir-Ritonavir, Efficacy, Safety
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 410 participants (estimated)
- Lead sponsor
- Shandong Provincial HospitalOther government
- Collaborators
- Qianfoshan Hospital, The Second Affiliated Hospital of Shandong First Medical University, The Affiliated Hospital Of Southwest Medical University, Gansu Provincial Hospital, Rizhao People's Hospital
- Study start
- 21 Jan 2023 (actual)
- Primary completion
- 21 May 2023 (estimated)
- Study completion
- 21 Jul 2023 (estimated)
- First posted
- 25 Jan 2023 (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.
The COVID-19 pandemic has become a major public health challenge, and the treatment options for the disease are currently limited. The commonly used oral small-molecule anti-COVID-19 drugs in China are Nirmatrelvir-Ritonavir and Azvudine. These drugs have been tested in pre-marketing clinical trials in patients with non-severe COVID-19 infection and have demonstrated therapeutic effects in inhibiting virus transmission and preventing disease progression. However, until now, the efficacy and safety of these drugs in patients with moderate to severe COVID-19 infections remains unclear. Therefore, this study is aiming to compare the efficacy and safety of Azvudine and Nirmatrelvir-Ritonavir in moderate to severe COVID-19 infections. This study will be a multicenter, randomized, controlled clinical trial study in patients hospitalized with moderate to severe COVID-19 infections. Recovery of clinical symptoms, nucleic acid negative conversion, improvement in oxygenation index, and imaging improvement will be used as study endpoints.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Azvudine | Experimental | Drug: Azvudine |
| Nirmatrelvir-Ritonavir | Active comparator | Drug: Nirmatrelvir-Ritonavir |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Hospitalized patients of ≥18 years old, regardless of gender or race;
- Patients who have a positive SARS-CoV-2 test result;
- Diagnosed with moderate or severe COVID-19 infection according to the diagnostic criteria from the "Diagnosis and treatment program trial version 10 guidelines" issued by the National Health Commission of the People's Republic of China. Including:
- ①Moderate: continuous high fever for more than 3 days or/and cough, shortness of breath, etc., but the breathing frequency (RR) is less than 30 times/minute, and the oxygen saturation when inhaling air at rest is > 93%. Imaging shows the characteristic manifestations of COVID-19 pneumonia.
- ② Severe: Adults meet any of the following requirements: A, shortness of breath, RR≥ 30 times/minute; B, the oxygen saturation when inhaling air at rest is ≤ 93%; C, Arterial partial oxygen pressure (PaO2)/ Fraction of inspiration O2 (FiO2) ≤300mmHg (1mmHg=0.133kPa), and PaO2/FiO2 should be corrected according to the following formula for areas above 1000 m :PaO2/FiO2× [760/ atmospheric pressure (mmHg)]; D, the clinical symptoms were gradually aggravated, and the lung imaging showed that the lesion progressed significantly within 24 ~ 48 hours > 50%.
Key exclusion criteria (9 listed)
- Allergic to the drugs involved;
- Pregnancy or lactation;
- Diagnosed or suspected critical COVID-19 infection;
- Child-Pugh C of liver function or estimated glomerular filtration rate (eGFR) less than 30mL/min during screening;
- Receive SARS-CoV-2 monoclonal antibody therapy or other antiviral therapy;
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 |
|---|---|---|
| Azvudine5mg orally, once a day, for no more than 14 days | Drug | Azvudine |
| Nirmatrelvir-RitonavirNirmatrelvir 300mg combined with Ritonavir 100mg every 12 hours for 5 days. For patients with 30≤ eGFR < 60 ml/min, it should be reduced to150mg/100mg Nirmatrelvir-Ritonavir every 12 hours for 5 days | Drug | Nirmatrelvir-Ritonavir |
Primary outcome
Time and proportion of patients with COVID-19 infection to have sustained clinical recovery
Time frame: Up to 28 days
6 secondary outcomes
Proportion of progression to critical COVID-19 and death from any cause
Time frame: Up to 28 days
Time of COVID-19 related symptom score and World Health Organization (WHO) clinical progress scale score. Time and proportion of clinical recovery, symptom resolution and regression of major symptoms
Time frame: Up to 28 days
Time and proportion of the nucleic acid negative conversion
Time frame: Days 3, 6, 9, 12, 15, 18, 21, 24, 27
Time and proportion of chest CT image improvement
Time frame: Days 6, 12, 18, 24
Time and proportion of oxygenation index improvement
Time frame: Up to 28 days
Length of stay
Time frame: Up to 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Azvudine and Nirmatrelvir-Ritonavir in people with COVID-19, run by Shandong Provincial Hospital 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 7 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: status not confirmed, as of the sponsor's last update on 27 Feb 2023. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Bing Leng (+86531-68776461, taozilb@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time and proportion of patients with COVID-19 infection to have sustained clinical recovery (time frame: Up to 28 days). 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 27 Feb 2023.