COVID-19
Conditions
Interventions
Patient Group:Not applicable
Sponsors
People's Hospital of Chongqing Banan District, Bishan Hosipital of Chongqing Medical university
Eligibility
Sex/Gender
All
Age
12 Years to 65 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria of healthy subjects group Subjects must meet all of the following inclusion criteria to be enrolled in the healthy subjects group: 1. Fully understand the purpose, nature, method and possible adverse reactions of the test, volunteer as a subject, and sign informed consent; 2. Healthy subjects aged from 12 to 65 years (including the boundary value, subject to the informed consent signed); 3. Agree that during the trial period (D-1~D7), except for this study, only samples of SARS-CoV-2 nucleic acid from oral and pharyngeal swabs will be taken, and no samples from nasopharyngeal swabs will be taken; 4. During the screening period, oral and pharyngeal swabs were taken and SARS-CoV-2 RNA Ct test results were negative (Ct value >= 35). Nasal/oropharyngeal swab results before signing informed consent were acceptable, but the interval between SARS-CoV-2 RNA Ct sampling time and first observation should be ensured to be no more than 24 hours. The minimum duration should not exceed 48 hours. Inclusion criteria of patient group Subjects must meet all of the following inclusion criteria to be enrolled in the patient group: 1. Fully understand the purpose, nature, method and possible adverse reactions of the test, volunteer as a subject, and sign informed consent; 2. Age from 12 to 65 years old (including the boundary value, subject to the signing of the informed consent); 3. Agree that during the trial period (D-1~D7), except for this study, only samples of SARS-CoV-2 nucleic acid from oral and pharyngeal swabs will be taken, and no samples from nasopharyngeal swabs will be taken; 4. During screening, SARS-CoV-2 was detected by RT-PCR in oral and pharyngeal swab specimens and the result was positive (Ct value < 35), and the sampling time for the first positive nucleic acid test was less than 2 days from D1 observation, and the first occurrence of related clinical symptoms was less than 2 days. Note: Nasal/oropharyngeal swab results were accepted prior to signing the informed consent. 5. At screening and baseline (D-1), patients were diagnosed with mild or normal COVID-19 according to the Protocol for Diagnosis and Treatment of SARS-CoV-2 Pneumonia (Trial Ninth Edition).
Exclusion criteria
Exclusion criteria: Exclusion criteria of healthy subjects group Subjects who presented with any of the following exclusion criteria were not enrolled in the healthy subjects group: 1. Diseases that developed or were developing abnormal clinical manifestations before screening requiring exclusion, including but not limited to the neurological/psychiatric system, respiratory system, cardiovascular and cerebrovascular system, digestive system (any history of gastrointestinal diseases affecting drug absorption), blood and lymphatic system, urinary system, endocrine system, and immune system diseases; 2. Anatomical abnormalities affecting drug absorption in acute exacerbation of chronic rhinitis or nose; 3. History of asthma; 4. Subjects who had been infected with SARS-CoV-2 within 3 months before D1 of the observation period; 5. Subjects who had received any new coronary prophylaxis or therapeutic drugs within 7 days before D1 of the observation period (or 5 half-lives of the drugs received, whichever was longer), including but not limited to SARS-CoV-2 monoclonal antibodies, sera of rehabilitation patients, and antiviral drugs (e.g., Paxlovid, Molnupiravir, Radicivir, Lopinavir/Ritonavir combination, Ribavirin, Chloroquine, Hydroxychloroquine and other drugs), and systemic or inhaled steroids (except long-term stable dose treatment for concomitant chronic diseases, and no dose increase; 6. Major organ surgery (excluding needle biopsy, tracheotomy, gastrostomy, etc.) or significant trauma within 28 days before D1 of the observation period, or the need for elective surgery during the trial; 7. Current acute or chronic moderate or severe liver disease, subjects with known hepatic or biliary abnormalities (except Gilbert 's syndrome or asymptomatic gallstones); 8. Subjects with current acute or chronic moderate or severe renal disease; 9. cardiovascular disease meeting any of the following criteria: 1) History of myocardial infarction within the previous 12 months; 2) Unstable angina; 3) Clinically significant and uncontrolled arrhythmias; 4) History of stroke or transient ischemic attack requiring medication within the past 12 months; 5) Congestive heart failure based on NYHA class >= II; 6) Localized edema >= Grade 3 (including respiratory, thoracic and mediastinal diseases: laryngeal edema, pulmonary edema; skin and subcutaneous tissue diseases: peripheral edema); 7) Clinically uncontrolled hypertension; 10.Suspected or confirmed active systemic infection, such as bacterial, fungal, viral, or other infection, or disease judged by the investigator to affect the assessment of the study endpoints; 11.Subjects with known HIV infection and positive Treponema pallidum antibody; 12.Subjects with liver disease who met any of the following: 1) Known active HBV infection; 2) Known HCV infection; 3) Primary biliary cirrhosis; 4) Moderate and severe fatty liver; 5) Child-Pugh class B or C; 6) Acute liver failure; 13.Female subjects who are pregnant or lactating during the screening period; 14.Participated in other drug clinical trials and used other investigational drugs within 1 month before screening; 15.Any other condition that, in the opinion of the investigator, might affect the subject's ability to give informed consent or to follow the trial protocol, or that the subject's participation in the trial might affect the trial's results or his/her own safety. Exclusion Criteria of Patients Group Subjects with any of the following exclusion cri
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Nucleic acid test;Antigen test; | — |
Countries
China
Contacts
Public ContactHu Yongjun, Guo Jinjun
People's Hospital of Chongqing Banan District, Bishan Hospital of Chongqing
Outcome results
None listed