The Efficacy of Azvudine and Paxlovid in High-risk Patients With COVID-19: A Prospective Randomized Controlled Trial

Study Overview
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Brief Summary
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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
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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).

Official Title
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The Efficacy of Azvudine and Paxlovid in High-risk Patients With COVID-19: A Prospective Randomized Controlled Trial

Conditions
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SARS-CoV-2 Infection

Intervention / Treatment
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* Drug: Azvudine
* Drug: Paxlovid group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Azvudine group<br>Patients received Azvudine orally, for 7 consecutive days (7 doses in total) . | Drug: Azvudine<br>* Patients received Azvudine orally, for 7 consecutive days (7 doses in total)<br>* Other names: treatment group;|
| Active Comparator: Paxlovid group<br>Patients received Paxlovid orally for 5 consecutive days (10 doses in total). | Drug: Paxlovid group<br>* Patients received Paxlovid orally for 5 consecutive days (10 doses in total).<br>* Other names: control group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 7 days after enrolled | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SARS-CoV-2, antivirus, COVID-19