研究疾病:
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新型冠状病毒肺炎
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研究疾病代码:
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Target disease:
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COVID-19
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Target disease code:
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研究类型:
Study type:
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干预性研究
Interventional study
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研究设计:
Study design:
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随机平行对照
randomized controlled trial(parallel group design)
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研究所处阶段:
Study phase:
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上市后药物
Post-marketing clinical trial
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研究目的:
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评价连花清瘟胶囊治疗轻、中度COVID-19成人患者的临床有效性、安全性和经济性。
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Objectives of Study:
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To evaluate the clinical efficacy, safety and economy of LHQW in the treatment of adult patients with mild and moderate COVID-19.
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药物成份或治疗方案详述:
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Description for medicine or protocol of treatment in detail:
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纳入标准:
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1.符合WHO规定的轻、中度(中国轻型、普通型)COVID-19诊断标准,且新冠病毒快速抗原检测阳性或核酸检测阳性患者。
2.年龄在18至70岁(含18至70岁)之间,男女不限。
3.症状出现和筛选之间的时间间隔最长不超过4天。(症状出现:COVID-19的体征和症状可能在暴露后2至14天出现,可能包括:咳嗽,鼻塞流涕,咽痛,气短(呼吸困难),精神不振或疲倦,肌痛或身体痛,头痛,发冷或寒战,感觉发热,恶心,呕吐,腹泻,新的嗅觉丧失和新的味觉丧失。症状的发作是受试者经历以上至少一种症状的开始时间。
4.筛选前12h内9个主要症状(鼻塞或流涕、咽痛、咳嗽、气短(呼吸困难)、精神不振或疲倦、肌痛或身体痛、头痛、发冷或寒战、感觉发热)中至少出现3个症状。
5.可以理解并遵守方案要求,可以提供签名的书面知情同意书。
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Inclusion criteria
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1.Adult patients with mild or moderate COVID-19 (WHO criterion), who received positive results on SARS-CoV-2 rapid antigen test or RT-PCR for confirmation of SARS-CoV-2 infection
2.Adult men and non-pregnant women, between 18 and 70 years old (including 18 and 70 years old).
3.The time interval between the onset of symptoms and screening shall be not exceed 4 days. (the occurrence of signs and symptoms of COVID-19 may appear on the 2nd to 14th days after exposure to SARS-CoV-2. The onset of symptoms is defined as occurring at least one of the following symptoms: cough, stuffy or runny nose, sore throat, shortness of breath (difficulty breathing), low energy or tiredness, muscle or body aches, headache, chills or shivering, feeling hot or feverish, nausea, vomiting, diarrhea, new loss of smell, and new loss of taste.)
4.At least 3 of the 9 major symptoms (stuffy or runny nose, sore throat, cough, shortness of breath (difficulty breathing), low energy or tiredness, muscle or body aches, headache, chills or shivering, feeling hot or feverish) occur within 12 hours before screening.
5.Can understand and comply with the requirements of the protocol, and can provide a signed written informed consent.
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排除标准:
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1.符合COVID-19重症以上诊断标准的患者。
2.经研究者判断,患有以下严重慢性系统性疾病影响疗效评价和疾病转归的情况:
① 控制不佳的糖尿病(规范降糖治疗情况下,入组前7天内随机血糖大于11.1mmol/L,或近三个月内糖化血红蛋白≥8%);
② 控制不佳的高血压(规范使用降压药物情况下,仍收缩压≥140mmH或舒张压≥90mmHg);
③ 慢性肺病,包括中重度COPD(慢性阻塞性肺疾病)、哮喘,肺间质性疾病、囊性纤维化和肺动脉高压);
④ 肿瘤,严重的心脑血管疾病(心力衰竭、心肌病、痴呆症、精神障碍等),严重影响免疫系统的疾病等;
⑤ 慢性肾脏疾病(包括慢性肾脏疾病3-5期),慢性肝脏疾病(如肝纤维化、肝硬化,或血清AST和/或ALT≥3倍正常值上限);
⑥ 严重肥胖:BMI≥35 kg//m2;
3.已知合并其他感染疾病的患者。
4.筛选入组前1年内有酗酒或药物滥用史(大麻使用除外)的患者。
5.筛选入组前1个月内参加其他药物临床试验者,如果接受的研究制剂具有较长的半衰期,应在筛查前的最后一次给药后超过5个半衰期。
6.已知或怀疑对试验药及其辅料有过敏史或过敏体质者。
7.怀孕或产后2周内或哺乳的女性患者。
8.由于可能违反试验方案或任何其他影响其安全性的情况,研究者认为不适合参与研究的患者。
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Exclusion criteria:
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1.Patients who meet COVID-19 diagnostic criteria of severe diseases or above.
2.By the assessment of investigator, patients who occur any of the following serious chronic systemic diseases that may affect the efficacy evaluation and disease regression:
①Poorly controlled diabetes (randomized blood glucose >11.1 mmol/L within 7 days prior to enrolment or glycated hemoglobin ≥8% within the last 3 months in the case of standardized glucose-lowering therapy);
②Poorly controlled hypertension (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg despite regulated use of antihypertensive medication);
③Chronic lung disease, including COPD (chronic obstructive pulmonary disease), asthma, interstitial lung disease, cystic fibrosis and pulmonary hypertension);
④Tumors, severe cardiovascular diseases (heart failure, cardiomyopathy, dementia, mental disorders, etc.), diseases that seriously affect the immune system, etc.
⑤Chronic kidney disease (including chronic kidney disease stages 3-5), chronic liver disease (e.g. liver fibrosis, cirrhosis, or serum AST and/or ALT ≥ 3 times the upper limit of normal).
⑥Severe obesity: BMI ≥35 kg/m2.
3.Patients with known co-morbidities of other infections.
4.Patients with a history of alcohol or drug abuse (other than cannabis use) within 1 year prior to enrollment.
5.Those participated in other clinical trials within 1 month prior to screening. If the investigational product has a long half-life, the time interval should be more than 5 half-lives from the last administration to screening of this study.
6.Persons with a known or suspected history of allergy or hypersensitivity to the investigational product and its excipients.
7.Female patients who are pregnant, breastfeeding or within 2 weeks of delivery.
8.Patients who, in the opinion of the investigator, are not suitable to participate in the study due to a possible breach of the trial protocol or any other circumstances affecting their safety.
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研究实施时间:
Study execute time:
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从From
2022-01-01
至To
2022-12-31
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征募观察对象时间:
Recruiting time:
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从From
2022-02-15
至To
2022-09-30
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