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

• Status: Recruiting
• Trial end date: 2023-04-30
• Target enrollment: 0
• Participant gender: All

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).

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Southeast University, China
• Collaborator: Hohhot First Hospital, Hohhot, Inner Mongolia, China

Criteria

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