ITMCTR2200005943尚未招募未知
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
Shuguang Hospital Affiliated to Shanghai University of traditional Chinese Medicine0 个研究点开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
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研究设计
- 研究类型
- Interventional study
入排标准
- 年龄范围
- 18 至 ??（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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.
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