The Efficacy of Azvudine and Paxlovid in High-risk Patients With COVID-19: A Prospective Randomized Controlled Trial
Study Details
Study Description
Brief 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 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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Azvudine group Patients received Azvudine orally, for 7 consecutive days (7 doses in total) . |
Drug: Azvudine
Patients received Azvudine orally, for 7 consecutive days (7 doses in total)
Other Names:
|
| Active Comparator: Paxlovid group Patients received Paxlovid orally for 5 consecutive days (10 doses in total). |
Drug: Paxlovid group
Patients received Paxlovid orally for 5 consecutive days (10 doses in total).
Other Names:
|
Outcome Measures
Primary Outcome Measures
- the proportion of patients RT-PCR negative for SARS-CoV-2 at 7 days [7 days after enrolled]
the proportion of patients RT-PCR negative for SARS-CoV-2 at 7 days
Secondary Outcome Measures
- the proportion of patients RT-PCR negative for SARS-CoV-2 at 14 days [14 days]
the proportion of patients RT-PCR negative for SARS-CoV-2 at 14 days
- the time to conversion from a positive RT-PCR test to 2 continuously negative test [14 days]
the time to conversion from a positive RT-PCR test to 2 continuously negative test
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients aged 18-85 years (inclusive).
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Meet the diagnostic criteria for COVID-19.
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At least one high risk factor for progression to severe COVID-19
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No more than 5 days from the onset of clinical symptoms
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Sign informed consent form.
Exclusion Criteria:
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Severe or critically patients with COVID-19
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Have received neutralizing antibodies or convalescent plasma therapy due to COVID-19
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Child-Pugh grade C or acute liver failure
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Chronic renal failure (eGFR<30 mL/min)
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Grade III or IV cardiac function, or known left ventricular ejection fraction < 30%
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Known or suspected history of active or extrapulmonary tuberculosis
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Patients who are allergic to the active ingredient of the drug
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Pregnant and lactating women
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hohhot First Hospital | Hohhot | Inner Mongolia | China | 010031 |
Sponsors and Collaborators
- Southeast University, China
- Hohhot First Hospital, Hohhot, Inner Mongolia, China
Investigators
- Principal Investigator: Songqiao Liu, MD. PhD., Southeast university
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IBR2022072