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

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ClinicalTrials.gov Identifier: NCT05642910
Recruitment Status : Recruiting
First Posted : December 8, 2022
Last Update Posted : December 8, 2022
Sponsor:
Collaborator:
Hohhot First Hospital, Hohhot, Inner Mongolia, China
Information provided by (Responsible Party):
Songqiao Liu, Southeast University, China

Study Description
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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).

Condition or disease Intervention/treatment Phase
SARS-CoV-2 Infection Drug: Azvudine Drug: Paxlovid group Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 540 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients who meet inclusion criteria will be randomized into the Azvudine group (treatment group) and Paxlovid group (control group).
Masking: None (Open Label)
Masking Description: Open Label
Primary Purpose: Treatment
Official Title: The Efficacy of Azvudine and Paxlovid in High-risk Patients With COVID-19: A Prospective Randomized Controlled Trial
Actual Study Start Date : October 18, 2022
Estimated Primary Completion Date : January 31, 2023
Estimated Study Completion Date : April 30, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: 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 Name: control group


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05642910


Contacts
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Contact: Songqiao Liu, MD. PhD. 086-13770723635 liusongqiao@ymail.com
Contact: Junjing Zhang, MD. PhD. 086-04175281618 zhang.jj@vip.163.com

Locations
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China, Inner Mongolia
Hohhot First Hospital Recruiting
Hohhot, Inner Mongolia, China, 010031
Contact: Junjing Zhang, Dr    086-04175281618    zhang.jj@vip.163.com   
Sponsors and Collaborators
Southeast University, China
Hohhot First Hospital, Hohhot, Inner Mongolia, China
Investigators
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Principal Investigator: Songqiao Liu, MD. PhD. Southeast university
More Information
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Responsible Party: Songqiao Liu, MD. PhD., Southeast University, China
ClinicalTrials.gov Identifier: NCT05642910    
Other Study ID Numbers: IBR2022072
First Posted: December 8, 2022    Key Record Dates
Last Update Posted: December 8, 2022
Last Verified: December 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We did not seek or receive approval for this data sharing from our Institutional Review Board .

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Songqiao Liu, Southeast University, China:
SARS-CoV-2
antivirus
COVID-19
Additional relevant MeSH terms:
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COVID-19
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Infections
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
 Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Nirmatrelvir and ritonavir drug combination
Antiviral Agents
Anti-Infective Agents