A Randomized Controlled Trial Assessing the Efficacy of Lianhua Qingwen as an Adjuvant Treatment in Patients With Mild Symptoms of COVID-19
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 主要终点
- Proportion of participants who test negative for COVID-19
研究概览
简要总结
COVID-19 virus remains in infected patients for extended periods of time. A great resource burden is placed on the healthcare system and society at large to isolate COVID-19 patients for prolonged periods. Thus, being able to increase the rate of viral clearance, thus reducing the duration of COVID-19 infection, would allow patients to be discharged earlier to free up resources for those who require it. The investigators designed a randomized controlled trial, investigating the use of Lianhua Qingwen, a TCM treatment, in COVID-19 infected patients with mild symptoms. The investigators hypothesize that the use of Lianhua Qingwen will increase the proportion of patients who test negative for COVID-19 after 8 days of TCM treatment when compared to the group of patients provided with standard care and placebo. Patients will be recruited from community isolation facilities, and have onset of symptoms within 5 days prior to admission to the isolation facility. The trial also evaluates the time taken for relief of clinical symptoms associated with COVID-19 and assesses the safety of the TCM treatment given to patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥21 years
- •Positive laboratory test for COVID-19 by RT-PCR methods
- •Presenting with at least one symptom (symptoms include fever, dry cough, sore throat, nasal congestion, malaise, headache, muscle pain, anosmia, and diarrhoea)
- •Length of time between date of onset of symptoms and the date of recruitment should not exceed 5 days to ensure that trial participants are in the early stages of infection
- •No clinical or radiographic evidence of pneumonia
- •Able to provide informed consent
排除标准
- •Individuals with underlying primary diseases such as cardiovascular, respiratory, liver, renal, diabetes, hepatitis A/B/C, gout or endocrinological diseases and neurological disorders which put them at a higher risk of developing severe disease
- •Individuals with compromised immune systems such as malignant tumors, organ or bone marrow transplants, HIV, or have taken immunosuppressants in the past three months.
- •Women who are pregnant or on lactation.
- •Individuals with mental illness.
- •History of allergy to any drug or food, or herb ingredient observed in this trial.
- •Individuals who are deemed not able to comply with trial procedure or follow-up
研究组 & 干预措施
Treatment group
干预措施: Lianhua Qingwen (Drug)
Control group
干预措施: Placebo (Drug)
结局指标
主要结局
Proportion of participants who test negative for COVID-19
时间窗: after 8 days of treatment
次要结局
- Time taken in days for relief of clinical symptoms(during the 8-day course of treatment)
- Proportion of participants who test positive for COVID-19 with Ct value>30(after 8 days of treatment)
- Proportion of participants with mild symptoms of COVID-19 progressing to moderate or severe illness(after 8 days of treatment and at the end of the trial)
研究者
Zhao Yan
Principal Investigator
Nanyang Technological University