A Pilot Randomized Controlled Clinical Study of Resveratrol for Discharged COVID 19 Patients in Order to Evaluate Its Therapeutic Effects Against Fibrosis
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- The handheld basic spirometry
研究概览
简要总结
A randomized controlled trial (RCT) will be conducted to evaluate the anti-fibrotic therapeutic effects of resveratrol on the clinical symptoms in discharged COVID-19 patients.
详细描述
The proposed study will be a randomized controlled trial (RCT) to evaluate the anti-fibrotic therapeutic effects of resveratrol on the clinical symptoms in discharged COVID-19 patients. The target population will be post-discharge patients recovering from COVID-19. Eligible participants will be recruited from the ongoing special Chinese Medicine program for discharged patients collaborated with Hong Kong Hospital Authority. Thirty (30) participants will be randomly assigned to resveratrol group and placebo group with 1:1 ratio. The participants will receive six months of treatment (1 g, orally and once daily) and three months of follow-up. The total duration of the clinical study is 9 months. The study protocol will be submitted to the Ethics Committee for review and approval. Participants will be enrolled and signed written informed consent.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The participants will be randomly assigned to resveratrol group and placebo group with 1:1 ratio. Block randomization with block size of 6 will be carried out in 1:1 ratio according to the sequence generated with Random Allocation Software (Version 2.0.0), Isfahan, Iran. Treatments will be assigned according to the codes which are kept in opaque sealed envelopes with consecutive randomization numbers. Treatment assignments will not be revealed and blinded to patients and PI (outcome assessor) until the whole study is completed.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants will be the patients aged 18-65 years old who have been previously diagnosed to be infected with COVID-19 and discharged from local hospitals after treatment with western medicines, and with negative results from COVID-19 virus detection. The subjects will be evaluated for potential pulmonary fibrosis and those who present with the condition resulting from COVID-19 infection will be included.
排除标准
- •Participants will be excluded if they have one or more of the followings: 1) inability to communicate (e.g. cognitive impairment); 2) history of Chinese medicine allergies; 3) incompetent in giving consent.
研究组 & 干预措施
Resveratrol group
Resveratrol group (treatment group) will be instructed to consume with capsules (1.0 g, orally once a day) for six months.
干预措施: Resveratrol (Drug)
Placebo group
Placebo group (control group) will be instructed to orally take placebo (edible paraffin, 1.0) once a day.
干预措施: Placebo capsules (Drug)
结局指标
主要结局
The handheld basic spirometry
时间窗: 9 months
Lung function will be assessed by the handheld basic spirometry (forced expiratory volume, FEV and forced vital capacity, FVC). FEV is the parameter to measure how much air the participants can force from their lungs in one second. Lower FEV-1 readings indicate more significant obstruction. FVC is the largest amount of air that the participants can forcefully exhale after breathing in as deeply as they can. A lower than normal FVC reading indicates restricted breathing. The participants will be trained to check these measurements at home and record the data in the patient diary.
Borg Category-Ratio 0-10 Scale
时间窗: 9 months
We will also use Borg Category-Ratio 0-10 Scale (Borg CR10 Scale) to measure dyspnea as recommended by the American College of Sports Medicine (ACSM) guidelines for patients with pulmonary diseases (Asha et al., 2012). The Borg Category Ratio 10 (CR10) Scale® (Borg Dyspnea Scale), will be used to rate the patients' dyspnea and overall fatigue level. Scale: 0=Rest; 0.5=Really Really Easy; 1=Really Easy; 2=Easy; 3=Moderate; 4=Sort of Hard; 5,6=Hard; 7,8,9=Really Hard; 10=Maximal
PRO scores
时间窗: 9 months
All the symptoms will be measured by PRO scores according to the clinical symptoms of COVID-19 rehabilitation patients. The scores will be ranged from 0-4: "0" indicates none; "1" indicates mild; "2" indicates moderate; "3" indicates moderately severe; and '4" indicates severe.
次要结局
- Body constitution questionnaires(9 months)
- Lung Function Questionnaire with 6-min walk-test(9 months)
- the World Health Organization Quality of Life Brief Assessment [WHOQOL-BREF (HK)](9 months)
研究者
Zhong Lidan
Assistant Professor
Hong Kong Baptist University