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

SARS-CoV-2 Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05642910
• Other study ID #: IBR2022072
• Status: Recruiting
• Phase: N/A
• Start date: October 18, 2022
• Est. completion date: April 30, 2023

Study information

• Verified date: December 2022
• Source: Southeast University, China
• Contact: Songqiao Liu, MD. PhD.
• Phone: 086-13770723635
• Email: liusongqiao[@]ymail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 540
• Est. completion date: April 30, 2023
• Est. primary completion date: January 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• SARS-CoV-2 Infection

Intervention

Drug:
• Azvudine
Patients received Azvudine orally, for 7 consecutive days (7 doses in total)
• Paxlovid group
Patients received Paxlovid orally for 5 consecutive days (10 doses in total).

Locations

Country	Name	City	State
China	Hohhot First Hospital	Hohhot	Inner Mongolia

Sponsors (2)

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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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