Novel coronavirus infection (COVID-19)
Conditions
Interventions
Routine treatment + azvudine:Azvudine 5mg / time, once a day
Routine treatment + Paxlovid:300mg Nirmatrelvir + 100mg Ritonavir, twice a day
Sponsors
Xiang'an Hospital of Xiamen University
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: 1. Age above 18 years old and below 90 years old. 2. Confirmed novel coronavirus infection in hospitalized patients. 3. According to the Expert Recommendation for Clinical Treatment of Severe novel Coronavirus Infection caused by Omicron Variant Strain, it is defined as severe or critically infected patients with novel coronavirus. Severe COVID-19 is defined in adult patients who meet any of the following criteria: respiratory distress, respiratory rate >=30 beats /min; In the resting state, oxygen saturation of finger is less than 93% when sucking air; Arterial partial oxygen pressure (PaO2)/oxygen absorption concentration (FiO2) <=300 mmHg; Patients with progressive aggravation of clinical symptoms and lung images showed obvious progression of lesion above 50% within 24~48 h. Critical COVID-19 is defined in adult patients who develop any of the following: respiratory failure and need mechanical ventilation; Shock; Combined with other organ failure. 4. Voluntarily sign a written informed consent.
Exclusion criteria
Exclusion criteria: 1. Previous or current medical conditions that may affect the patient's participation in the trial or their disease outcomes, including: primary immunodeficiency disease, acquired immune deficiency syndrome, malignant tumor, autoimmune disease, hematological malignancies (such as leukemia, multiple myeloma, myelodysplastic syndrome, etc) , splenectomy and organ transplantation patients, severely impaired liver and kidney function (child-pugh score more than 10, creatinine clearance less than 30%). 2. Received radiotherapy and chemotherapy, cytotoxic drugs and anti-lymphocyte antibodies within the last 3 months. 3. Pregnant or lactating women. 4. Allergic constitution, such as allergic history of two or more drugs or food, or known allergy to the ingredients of these drugs. 5. Patients who have participated in other clinical trials within the last 3 months. 6. As determined by the investigator, there were any factors that were not suitable for inclusion or affected the efficacy evaluation of the subjects.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 28-day survival rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Mechanical ventilation duration;ICU duration;SARS-CoV-2 viral load in throat swabs;Oxygenation index improvement rate;Inflammatory response indicators;Blood biochemical indicators;Routine blood test;Rate of chest CT improvement;Adverse events of drugs;Sequential Organ Failure Assessment;Acute Physiology, Age and Chronic Health Evaluation; | — |
Countries
China
Contacts
Public ContactLi Ke/Zheng Yali
Xiang'an Hospital of Xiamen University
Outcome results
None listed