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

Not Applicable

Recruiting

• Conditions: SARS-CoV-2 Infection
• Interventions: Drug: Paxlovid group; Drug: Azvudine

• Registration Number: NCT05642910
• Lead Sponsor: Southeast University, China

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).

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 Timeline

• Study Start: 2022-10-18
• Status Verified: 2022-12
• Study First Submitted: 2022-12-07
• Study First Submitted QC: 2022-12-07
• Last Update Submitted: 2022-12-07
• Study First Posted: 2022-12-08
• Last Update Posted: 2022-12-08
• Primary Completion: 2023-01-31
• Study Completion: 2023-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 540

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Paxlovid group	Paxlovid group	Patients received Paxlovid orally for 5 consecutive days (10 doses in total).
Azvudine group	Azvudine	Patients received Azvudine orally, for 7 consecutive days (7 doses in total) .

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Hohhot First Hospital; 🇨🇳 Hohhot, Inner Mongolia, China