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

December 7, 2022 updated by: Songqiao Liu, Southeast University, China
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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

540

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Inner Mongolia
      • Hohhot, Inner Mongolia, China, 010031
        • Recruiting
        • Hohhot First Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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:
  • treatment group
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:
  • control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the proportion of patients RT-PCR negative for SARS-CoV-2 at 7 days
Time Frame: 7 days after enrolled
the proportion of patients RT-PCR negative for SARS-CoV-2 at 7 days
7 days after enrolled

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the proportion of patients RT-PCR negative for SARS-CoV-2 at 14 days
Time Frame: 14 days
the proportion of patients RT-PCR negative for SARS-CoV-2 at 14 days
14 days
the time to conversion from a positive RT-PCR test to 2 continuously negative test
Time Frame: 14 days
the time to conversion from a positive RT-PCR test to 2 continuously negative test
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Southeast University, China

Collaborators

Hohhot First Hospital, Hohhot, Inner Mongolia, China

Investigators

  • Principal Investigator: Songqiao Liu, MD. PhD., Southeast university

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 18, 2022

Primary Completion (Anticipated)

January 31, 2023

Study Completion (Anticipated)

April 30, 2023

Study Registration Dates

First Submitted

December 7, 2022

First Submitted That Met QC Criteria

December 7, 2022

First Posted (Estimate)

December 8, 2022

Study Record Updates

Last Update Posted (Estimate)

December 8, 2022

Last Update Submitted That Met QC Criteria

December 7, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IBR2022072

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

We did not seek or receive approval for this data sharing from our Institutional Review Board .

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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