A real world study comparing the efficacy and safety of Jingyin granule and paxlovid in the treatment of novel coronavirus pneumonia (covid-19) with high risk factors
- Conditions
- COVID-19
- Registration Number
- ITMCTR2200005943
- Lead Sponsor
- Shuguang Hospital Affiliated to Shanghai University of traditional Chinese Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
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.
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.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ucleic acid negative conversion rate within 7 days;Conversion rate to severe within 28 days;
- Secondary Outcome Measures
Name Time Method Clinical symptom efficacy: refers to the disappearance rate and improvement rate of clinical symptoms before and after treatment;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;