Graphene Photothermal Adjuvant Therapy for Mild Corona Virus Disease 2019: A Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 270
- 试验地点
- 1
- 主要终点
- The time from positive at baseline to negative SARS-CoV-2 nucleic acid test
研究概览
简要总结
This is a future-proof and randomized controlled clinical study on the clinical efficacy of graphene photothermal adjuvant therapy in Corona Virus Disease 2019(COVID-19) patients with mild symptoms. The objective is to examine the effect of graphene photothermal adjuvant therapy on the time line for such Corona Virus Disease 2019 patients to achieve a negative severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) nucleic acid test result, and their duration of disease. Patients who meet study criteria will be randomized into the Grapheme adjuvant therapy combined with conventional therapy group (treatment group) and the conventional therapy only group (control group). Contrasted to the control groups, the treatment groups will undergo 30-min of graphene adjuvant therapy every day for 7 d.
详细描述
Following enrollment, patients will be randomized into treatment or control groups. All groups will receive the same conventional therapy.
In addition, treatment groups will undergo Graphene adjuvant therapy 30 minutes per day for 7 d.
Upon completion of the treatment protocol, specific study endpoints will be compared between the treatment and control groups.
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
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet the diagnostic criteria for mild COVID-
- •Patients aged 18-60 years (inclusive).
- •No later than 48 h after testing positive and the onset of clinical symptoms
- •Sign informed consent form.
排除标准
- •Severe or critically patients with COVID-
- •Resting heart rate over 120 beats per minute.
- •Coronary heart disease patients with acute cardiac insufficiency.
- •Acute exacerbation of chronic obstructive pulmonary disease（COPD）.
- •Uncontrolled hypertension [resting systolic blood pressure(SBP) more than 180 mmHg and diastolic blood pressure(DBP) more than 90 mmHg]; uncontrolled diabetes(Random Plasma Glucose, RPG>16.7mmol/L, HbA1C>7.0%)
- •Patients with severe cardiovascular, hepatic, renal and hematopoietic diseases.
- •Pregnant or menstruating woman.
- •Known or suspected history of active tuberculosis or extrapulmonary tuberculosis, patients with brucellosis, pneumonia-related illness from other causes
- •COVID-19 patients for the second or more times
- •Those who cannot cooperate due to various reasons
- •Body temperature: more than 38℃.
结局指标
主要结局
The time from positive at baseline to negative SARS-CoV-2 nucleic acid test
时间窗: through study completion, an average of 10 days
The time for grouped patients to receive a negative SARS-CoV-2 nucleic acid test result, including both ORF gene Ct value≥35 and N gene Ct value≥35.
次要结局
- Negative test rate within 7 days(7 days)
- Mild to moderate rate within 14 days(14 days)
- Hospital stay(through study completion, an average of 15 days)
研究者
Songqiao Liu
Zhongda Hospital
Southeast University, China