A Study of Efficacy and Safety of Azvudine vs. Nirmatrelvir-Ritonavir in the Treatment of COVID-19 Infection
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
1 other identifier
interventional
410
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 covid19
Started Jan 2023
Shorter than P25 for phase_4 covid19
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 20, 2023
CompletedStudy Start
First participant enrolled
January 21, 2023
CompletedFirst Posted
Study publicly available on registry
January 25, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 21, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
July 21, 2023
CompletedFebruary 27, 2023
February 1, 2023
4 months
January 20, 2023
February 24, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time and proportion of patients with COVID-19 infection to have sustained clinical recovery
Up to 28 days
Secondary Outcomes (6)
Proportion of progression to critical COVID-19 and death from any cause
Up to 28 days
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
Up to 28 days
Time and proportion of the nucleic acid negative conversion
Days 3, 6, 9, 12, 15, 18, 21, 24, 27
Time and proportion of chest CT image improvement
Days 6, 12, 18, 24
Time and proportion of oxygenation index improvement
Up to 28 days
- +1 more secondary outcomes
Study Arms (2)
Azvudine
EXPERIMENTALNirmatrelvir-Ritonavir
ACTIVE COMPARATORInterventions
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
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shandong Provincial Hospitallead
- Qianfoshan Hospitalcollaborator
- The Second Affiliated Hospital of Shandong First Medical Universitycollaborator
- The Affiliated Hospital Of Southwest Medical Universitycollaborator
- Gansu Provincial Hospitalcollaborator
- Rizhao People's Hospitalcollaborator
Study Sites (1)
Shandong Provincial Hospital
Jinan, Shandong, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director
Study Record Dates
First Submitted
January 20, 2023
First Posted
January 25, 2023
Study Start
January 21, 2023
Primary Completion
May 21, 2023
Study Completion
July 21, 2023
Last Updated
February 27, 2023
Record last verified: 2023-02