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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
410
5mg orally, once a day, for no more than 14 days
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
Shandong Provincial Hospital
Jinan, Shandong, China
RECRUITINGTime and proportion of patients with COVID-19 infection to have sustained clinical recovery
Time frame: Up to 28 days
Proportion of progression to critical COVID-19 and death from any cause
Time frame: 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
Time frame: Up to 28 days
Time and proportion of the nucleic acid negative conversion
Time frame: Days 3, 6, 9, 12, 15, 18, 21, 24, 27
Time and proportion of chest CT image improvement
Time frame: Days 6, 12, 18, 24
Time and proportion of oxygenation index improvement
Time frame: Up to 28 days
Length of stay
Time frame: Up to 28 days
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