Coronavirus disease 2019
Conditions
Interventions
Trial Drug:PO, 3 times a day, 4 tablets each time, for 5 consecutive days.
Control:PO, 3 times a day, 4 tablets each time, for 5 consecutive days.
Sponsors
Third People's Hospital of Shenzhen
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-75 years old on the day of enrollment, regardless of gender; 2. According to the "New Coronavirus Infection Diagnosis and Treatment Program (Trial Version 10)", the subjects were clinically diagnosed as mild or moderate; at least one symptom or sign related to the new coronavirus infection (fever, cough, sore throat or dry throat, nasal congestion or runny nose, weakness or fatigue, headache, muscle or body pain, (or soreness) shortness of breath or difficulty breathing, nausea, vomiting, diarrhea). One or more target COVID-19 related symptoms with a score of 2 or more within 24 hours before the first dose; the first occurrence of novel coronavirus infection related symptoms to randomization and first dose within 5 days; 3. The Ct value of SARS-CoV-2 virus nucleic acid test during the screening period (the day of the first dose (within 24 hours)) is =25; 4. The subjects (male and female of childbearing age) and their sexual partners voluntarily take effective contraceptive measures from the signing of the informed consent form to 1 month after the administration of the trial drug, and have no sperm or egg donation plan; female patients who do not need to undergo a pregnancy test before administration must meet one of the following conditions: a. Postmenopausal women who have stopped menstruating for 12 months or more, if they are under 60 years old, must be verified by a follicle-stimulating hormone test; b. Women who have undergone hysterectomy, bilateral oophorectomy or tubal ligation for sterilization; 5. The subjects have the willingness and ability to take the trial drug (tablets) orally; 6. The subjects can communicate well with the researchers, understand and comply with the procedures, methods and requirements of this clinical trial, and after fully informed consent, the subjects voluntarily participate and sign the informed consent form, or have a legal representative who can provide the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients are currently in urgent need of or are expected to require high-level respiratory support measures such as high-flow oxygen therapy, positive pressure ventilation, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO); 2. Patients have clinical signs of severe COVID-19, including: respiratory rate =30 times/minute, heart rate =125 times/minute, oxygen saturation (SpO2) =93% or oxygenation index (PaO2/FiO2) =300mmHg in the 24 hours before randomization; 3. Patients have a known history of active liver disease (excluding non-alcoholic hepatic steatosis), including active hepatitis B or C infection, primary biliary cirrhosis, Child-Pugh B or C liver function impairment, or acute liver failure. Liver function at screening shows any of the following: serum alanine aminotransferase (ALT) greater than >3× upper limit of normal (ULN); serum aspartate aminotransferase (AST) greater than >3×ULN; serum bilirubin greater than >2×ULN; 4. Under dialysis treatment, or known moderate to severe renal impairment (i.e., eGFR value calculated using serum creatinine-based CKD-EPI formula =45 mL/min/1.73 m² within 6 months before screening); 5. Moderate to severe congestive heart failure within 6 months before screening (according to the New York Heart Association classification standard, heart function is class III or IV), experienced cerebrovascular accident, myocardial infarction, coronary artery stent implantation; or uncontrolled hypertension (defined as systolic blood pressure exceeding 160 mmHg or diastolic blood pressure exceeding 100 mmHg, with relevant records). Significant or clinically relevant electrocardiogram abnormalities, such as second-degree type II atrioventricular block, left bundle branch block, etc.; 6. Subjects have difficulty swallowing or suffer from gastrointestinal diseases that seriously affect drug absorption (including reflux esophagitis, chronic diarrhea, inflammatory bowel disease, intestinal tuberculosis, gastrinoma, short bowel syndrome, post-subtotal gastrectomy, pancreatic enzyme deficiency, malabsorption syndrome and intestinal obstruction, etc.); 7. Acute exacerbation of chronic respiratory diseases: including bronchial asthma and chronic obstructive pulmonary disease; 8. Infection with influenza A or B within 1 month before screening; suspected or confirmed concurrent active systemic infection other than COVID-19, such as influenza and respiratory syncytial virus (RSV) during screening; or a high probability of bacterial infection based on symptoms, signs, or laboratory tests or imaging, which may interfere with the evaluation of the response to the study intervention; 9. Impaired immune system, including but not limited to patients receiving long-term immunosuppressive therapy, or known human immunodeficiency virus (HIV) infection (CD4+T cell count> 350 cells/mm3, HIV-RNA negative for more than one year can be included); 10. Allergic or other contraindications to any component of the study intervention; 11. Infected with the new coronavirus within 3 months before randomization; 12. History of malignant tumors within 5 years before screening (except basal cell carcinoma of the skin, cured squamous cell carcinoma of the skin, and cervical carcinoma in situ), and tumor patients who need to be treated during the expected study; 13. Glycated hemoglobin>7% during screening; 14. Other diseases that the researchers judge will seriously affect antiviral immunity or are not suitable for part
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in SARS-CoV-2 viral load relative to baseline at each time point; | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the time to first sustained recovery of 11 clinical symptoms in patients with mild and moderate COVID-19 (defined as the time from the first dose to the COVD-19 symptom score of 0 for 48 hours);;To evaluate the time to first sustained relief of 11 clinical symptoms in patients with mild and moderate COVID-19 (defined as the time from the first dose to when the COVID-19 symptom score was 0 or 1 and lasted for 48 hours);;The time when the virus nucleic acid test turns from positive to negative;;The percentage of subjects who turned negative on days 3, 4, 5, 7, and 10;;The percentage of subjects with clinical symptom resolution on Days 1, 3, 4, 5, 7, 10, 14, 21, and 28 (clinical symptom resolution was defined as the period from the first dose to a COVID-19 symptom score of 0);;Changes in the subjects' WHO Clinical Progress Scale assessment from baseline to days 1, 3, 4, 5, 7, 10, 14, and 28;;The types and severity of new symptoms (11 target COVID-19 symptoms) that occurred after the subjects took the drug and throughout the study period;;Percentage of subjects with COVID-19 progression (defined as severe/critical COVID-19 or all-cause death) by Day 28;;The percentage of subjects who died from any cause by Day 28;;Safety Assessment Results (AEs and SAEs) as of Day 28; | — |
Countries
China
Contacts
Public ContactHongzhou Lu
Third People's Hospital of Shenzhen
Outcome results
None listed