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A Study of Efficacy and Safety of Azvudine vs. Nirmatrelvir-Ritonavir in the Treatment of COVID-19 Infection

Primary Purpose

COVID-19

Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Azvudine
Nirmatrelvir-Ritonavir
Sponsored by
Shandong Provincial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19 focused on measuring COVID-19, Azvudine, Nirmatrelvir-Ritonavir, Efficacy, Safety

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Hospitalized patients of ≥18 years old, regardless of gender or race; Patients who have a positive SARS-CoV-2 test result; Diagnosed with moderate or severe COVID-19 infection according to the diagnostic criteria from the "Diagnosis and treatment program trial version 10 guidelines" issued by the National Health Commission of the People's Republic of China. Including: ①Moderate: continuous high fever for more than 3 days or/and cough, shortness of breath, etc., but the breathing frequency (RR) is less than 30 times/minute, and the oxygen saturation when inhaling air at rest is > 93%. Imaging shows the characteristic manifestations of COVID-19 pneumonia. ② Severe: Adults meet any of the following requirements: A, shortness of breath, RR≥ 30 times/minute; B, the oxygen saturation when inhaling air at rest is ≤ 93%; C, Arterial partial oxygen pressure (PaO2)/ Fraction of inspiration O2 (FiO2) ≤300mmHg (1mmHg=0.133kPa), and PaO2/FiO2 should be corrected according to the following formula for areas above 1000 m :PaO2/FiO2× [760/ atmospheric pressure (mmHg)]; D, the clinical symptoms were gradually aggravated, and the lung imaging showed that the lesion progressed significantly within 24 ~ 48 hours > 50%. Join this study voluntarily. Each subject must sign an informed consent form (ICF) indicating that he/she understands the purpose and procedure of the study and is willing to participate in the study. Considering the patient's condition, the ICF may be signed by the legal representative. Exclusion Criteria: Allergic to the drugs involved; Pregnancy or lactation; Diagnosed or suspected critical COVID-19 infection; Child-Pugh C of liver function or estimated glomerular filtration rate (eGFR) less than 30mL/min during screening; Receive SARS-CoV-2 monoclonal antibody therapy or other antiviral therapy; The subject and/or authorized family members refused to receive anti-COVID-19 treatment; Any life-threatening disease or organ system dysfunction that the researcher thinks can harm the safety of the subjects and expose the research results to unnecessary risks; drug addicts, uncontrolled mental illness or cognitive dysfunction. Join other similar clinical researchers within 3 months; Patients who were not considered suitable for inclusion by the researchers (such as patients who were expected to be unable to adhere to the treatment due to financial problems).

Sites / Locations

  • Shandong Provincial HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Azvudine

Nirmatrelvir-Ritonavir

Arm Description

Outcomes

Primary Outcome Measures

Time and proportion of patients with COVID-19 infection to have sustained clinical recovery

Secondary Outcome Measures

Proportion of progression to critical COVID-19 and death from any cause
Time of COVID-19 related symptom score and World Health Organization (WHO) clinical progress scale score. Time and proportion of clinical recovery, symptom resolution and regression of major symptoms
Time and proportion of the nucleic acid negative conversion
Time and proportion of chest CT image improvement
Time and proportion of oxygenation index improvement
Length of stay

Full Information

First Posted
January 20, 2023
Last Updated
February 24, 2023
Sponsor
Shandong Provincial Hospital
Collaborators
Central hospital Affiliated to Shandong First Medical University, The Second Affiliated Hospital of Shandong First Medical University, The Affiliated Hospital Of Southwest Medical University, Gansu Provincial Hospital, Rizhao People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05697055
Brief Title
A Study of Efficacy and Safety of Azvudine vs. Nirmatrelvir-Ritonavir in the Treatment of COVID-19 Infection
Official Title
A Prospective Multicenter, Randomized, Controlled Clinical Trial of the Safety and Efficacy of Azvudine vs. Nirmatrelvir-Ritonavir in Hospitalized Patients With Moderate to Severe COVID-19 Infection
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 21, 2023 (Actual)
Primary Completion Date
May 21, 2023 (Anticipated)
Study Completion Date
July 21, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shandong Provincial Hospital
Collaborators
Central hospital Affiliated to Shandong First Medical University, The Second Affiliated Hospital of Shandong First Medical University, The Affiliated Hospital Of Southwest Medical University, Gansu Provincial Hospital, Rizhao People's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The COVID-19 pandemic has become a major public health challenge, and the treatment options for the disease are currently limited. The commonly used oral small-molecule anti-COVID-19 drugs in China are Nirmatrelvir-Ritonavir and Azvudine. These drugs have been tested in pre-marketing clinical trials in patients with non-severe COVID-19 infection and have demonstrated therapeutic effects in inhibiting virus transmission and preventing disease progression. However, until now, the efficacy and safety of these drugs in patients with moderate to severe COVID-19 infections remains unclear. Therefore, this study is aiming to compare the efficacy and safety of Azvudine and Nirmatrelvir-Ritonavir in moderate to severe COVID-19 infections. This study will be a multicenter, randomized, controlled clinical trial study in patients hospitalized with moderate to severe COVID-19 infections. Recovery of clinical symptoms, nucleic acid negative conversion, improvement in oxygenation index, and imaging improvement will be used as study endpoints.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
COVID-19, Azvudine, Nirmatrelvir-Ritonavir, Efficacy, Safety

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
410 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Azvudine
Arm Type
Experimental
Arm Title
Nirmatrelvir-Ritonavir
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Azvudine
Intervention Description
5mg orally, once a day, for no more than 14 days
Intervention Type
Drug
Intervention Name(s)
Nirmatrelvir-Ritonavir
Intervention Description
Nirmatrelvir 300mg combined with Ritonavir 100mg every 12 hours for 5 days. For patients with 30≤ eGFR < 60 ml/min, it should be reduced to150mg/100mg Nirmatrelvir-Ritonavir every 12 hours for 5 days
Primary Outcome Measure Information:
Title
Time and proportion of patients with COVID-19 infection to have sustained clinical recovery
Time Frame
Up to 28 days
Secondary Outcome Measure Information:
Title
Proportion of progression to critical COVID-19 and death from any cause
Time Frame
Up to 28 days
Title
Time of COVID-19 related symptom score and World Health Organization (WHO) clinical progress scale score. Time and proportion of clinical recovery, symptom resolution and regression of major symptoms
Time Frame
Up to 28 days
Title
Time and proportion of the nucleic acid negative conversion
Time Frame
Days 3, 6, 9, 12, 15, 18, 21, 24, 27
Title
Time and proportion of chest CT image improvement
Time Frame
Days 6, 12, 18, 24
Title
Time and proportion of oxygenation index improvement
Time Frame
Up to 28 days
Title
Length of stay
Time Frame
Up to 28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Hospitalized patients of ≥18 years old, regardless of gender or race; Patients who have a positive SARS-CoV-2 test result; Diagnosed with moderate or severe COVID-19 infection according to the diagnostic criteria from the "Diagnosis and treatment program trial version 10 guidelines" issued by the National Health Commission of the People's Republic of China. Including: ①Moderate: continuous high fever for more than 3 days or/and cough, shortness of breath, etc., but the breathing frequency (RR) is less than 30 times/minute, and the oxygen saturation when inhaling air at rest is > 93%. Imaging shows the characteristic manifestations of COVID-19 pneumonia. ② Severe: Adults meet any of the following requirements: A, shortness of breath, RR≥ 30 times/minute; B, the oxygen saturation when inhaling air at rest is ≤ 93%; C, Arterial partial oxygen pressure (PaO2)/ Fraction of inspiration O2 (FiO2) ≤300mmHg (1mmHg=0.133kPa), and PaO2/FiO2 should be corrected according to the following formula for areas above 1000 m :PaO2/FiO2× [760/ atmospheric pressure (mmHg)]; D, the clinical symptoms were gradually aggravated, and the lung imaging showed that the lesion progressed significantly within 24 ~ 48 hours > 50%. Join this study voluntarily. Each subject must sign an informed consent form (ICF) indicating that he/she understands the purpose and procedure of the study and is willing to participate in the study. Considering the patient's condition, the ICF may be signed by the legal representative. Exclusion Criteria: Allergic to the drugs involved; Pregnancy or lactation; Diagnosed or suspected critical COVID-19 infection; Child-Pugh C of liver function or estimated glomerular filtration rate (eGFR) less than 30mL/min during screening; Receive SARS-CoV-2 monoclonal antibody therapy or other antiviral therapy; The subject and/or authorized family members refused to receive anti-COVID-19 treatment; Any life-threatening disease or organ system dysfunction that the researcher thinks can harm the safety of the subjects and expose the research results to unnecessary risks; drug addicts, uncontrolled mental illness or cognitive dysfunction. Join other similar clinical researchers within 3 months; Patients who were not considered suitable for inclusion by the researchers (such as patients who were expected to be unable to adhere to the treatment due to financial problems).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bing Leng
Phone
+86531-68776461
Email
taozilb@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Chengwu Shen
Phone
+86531-68778252
Email
scw810@163.com
Facility Information:
Facility Name
Shandong Provincial Hospital
City
Jinan
State/Province
Shandong
Country
China
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

A Study of Efficacy and Safety of Azvudine vs. Nirmatrelvir-Ritonavir in the Treatment of COVID-19 Infection

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