COVID-19
Conditions
Interventions
Test group:Basic treatment + Jingyin Qinghua formula, 2 bags / time, tid × 7 days
control group:Basic treatment + paxlovid (nematevir 300mg + ritonavir 100mg), Q12h × Five days.
Sponsors
Shuguang Hospital Affiliated to Shanghai University of traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Only those who meet all the following criteria can be selected: (1) Age = 18 years old (including 18 years old), regardless of gender; (2) Meet the diagnostic criteria of COVID-19; (3) All subjects were required to meet one or more of the following high-risk factors for progression to severe covid-19, including death a. Age = 60 years old; b. Cardiovascular disease (including congenital heart disease) or hypertension; c. Chronic lung diseases (e.g., chronic obstructive pulmonary disease [COPD], asthma [moderate to severe], interstitial lung disease, cystic fibrosis and pulmonary hypertension); d. Diabetes; e. There are immunosuppressive diseases or receiving immunosuppressive treatment (such as the decline of immune function caused by long-term use of corticosteroids or other immunosuppressive drugs); f. Obese or overweight (BMI > 25 kg / m2); g. Active cancer; h. Chronic kidney disease; i. Current smokers; j. Neurodevelopmental diseases (e.g. cerebral palsy, Down syndrome) or other diseases that lead to medical complexity (e.g. genetic or metabolic syndrome and severe congenital abnormalities); k. Need relevant medical support (not related to covid-19) (such as organotomy, gastrostomy or positive pressure ventilation); l. Other medical conditions or factors judged by researchers may also put individual patients at high risk of developing severe covid-19. The benefits and risks of individual patients should be weighed. (4) Voluntarily participate in the experiment and sign the written informed consent.
Exclusion criteria
Exclusion criteria: If any of the following criteria is met, it shall be excluded: (1) According to the judgment of the researcher, the subject may progress to severe / critical illness covid-19 before randomization; (2) SpO2 = 93% or PaO2 / FiO2 = 300 in indoor air at sea level, or respiratory rate = 30 / min; (3) Mechanical ventilation is needed or expected to be urgently needed; (4) The subject has eye diseases (such as inflammation, vascular malformation, retinal hemorrhage or detachment, optic neuropathy or fundus disease); (5) During the screening period, there are one of the following situations: a) ALT or ast > 1.5x ULN b)eGFR <30 mL/min (6) Known allergy to any ingredient used in the intervention drug dosage form; (7) Any medical treatment that the investigator believes will impair the subject's safety; (8) The subject has received sars-cov-2 monoclonal antibody treatment or preventive or antiviral treatment; (9) The subject has received convalescent covid-19 plasma treatment; (10) The subjects used the drugs prohibited in the combination Manual of matavir tablets / ritonavir tablets; (11) Subjects have participated in clinical studies involving study drug intervention in the past 30 days. If previous studies; (12) If the half-life of drug intervention is long, it should go through 5 half-life or 30 days (whichever is longer); (13) Any other type of medical research that the subjects are considered to be incompatible with the research in science or medicine at the same time; (14) Female subjects were pregnant or breastfeeding or planned pregnancy during the study period; (15) The wife or partner of male subjects planned to become pregnant during the study period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Nucleic acid negative conversion rate within 7 days;Conversion rate to severe within 28 days; | — |
Secondary
| Measure | Time frame |
|---|---|
| Average length of stay: the average time from admission to discharge;Average time of nucleic acid turning negative: the time from the patient's first positive report of CDC novel coronavirus nucleic acid test in Shanghai to two turns negative at an interval of more than 24 hours;Clinical symptom efficacy: refers to the disappearance rate and improvement rate of clinical symptoms before and after treatment; | — |
Countries
CHINA
Contacts
Public Contactgaoyueqiu
Shuguang Hospital Affiliated to Shanghai University of traditional Chinese Medicine
Outcome results
None listed