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

Southeast University, China

Status: Enrolling

Conditions: SARS-CoV-2 Infection

Treatments: Drug: Paxlovid group; Drug: Azvudine

Study type: Interventional

Funder types: Other

Identifiers

NCT05642910

IBR2022072

Details and patient eligibility

About

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).

Full 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).

Enrollment: 540 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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540 participants in 2 patient groups

Azvudine group

Experimental group

Description:

Patients received Azvudine orally, for 7 consecutive days (7 doses in total) .

Treatment:

Drug: Azvudine

Paxlovid group

Active Comparator group

Description:

Patients received Paxlovid orally for 5 consecutive days (10 doses in total).

Treatment:

Drug: Paxlovid group