The Anti-fibrotic Therapeutic Effects of Resveratrol for Discharged COVID-19 Patients (HKCOVID19Res)
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|ClinicalTrials.gov Identifier: NCT04799743|
Recruitment Status : Recruiting
First Posted : March 16, 2021
Last Update Posted : July 16, 2021
|Condition or disease||Intervention/treatment||Phase|
|Covid-19||Drug: Resveratrol Drug: Placebo capsules||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomized, Double-Blind, Placebo-Controlled Parallel Group Clinical Trial|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||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.|
|Official Title:||A Pilot Randomized Controlled Clinical Study of Resveratrol for Discharged COVID 19 Patients in Order to Evaluate Its Therapeutic Effects Against Fibrosis|
|Actual Study Start Date :||April 1, 2021|
|Estimated Primary Completion Date :||May 2022|
|Estimated Study Completion Date :||May 2022|
Experimental: Resveratrol group
Resveratrol group (treatment group) will be instructed to consume with capsules (1.0 g, orally once a day) for six months.
Resveratrol has been used as a food supplement. Its antiviral properties have been well studied including its inhibitory effect against the coronavirus MERS-CoV. Our previous in vitro and in vivo studies found that the compound had other health benefits such as anti-fibrotic effect.The anti-fibrotic effect will add an extra benefit for resveratrol to fight against COVID-19 as lungs are the most affected organs by the coronavirus, which may result in prolonged fibrotic damage of the lungs even when a patient is recovered from the COVID-19 disease.
Other Name: Resveratrol Capsule
Placebo Comparator: Placebo group
Placebo group (control group) will be instructed to orally take placebo (edible paraffin, 1.0) once a day.
Drug: Placebo capsules
The placebo consist of mainly starch and microcrystalline cellulose, the usage and dosage are the same as the investigational drug.
Other Name: Study drug
- The handheld basic spirometry [ Time Frame: 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.
- PRO scores [ Time Frame: 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.
- Borg Category-Ratio 0-10 Scale [ Time Frame: 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.
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
- Lung Function Questionnaire with 6-min walk-test [ Time Frame: 9 months ]Lung Function Questionnaire is a simple, brief, self-administered instrument to identify patients appropriate for lung function evaluation by 5 items about the breathing problems and/or frequent cough. It was validated in Chinese and widely used in primary care (Hanania et al., 2010).
- the World Health Organization Quality of Life Brief Assessment [WHOQOL-BREF (HK)] [ Time Frame: 9 months ]WHOQOL-BREF (HK) (Leung, K F., et al., 2005) was validated in Hong Kong and widely use in academia and clinicians since 1997. This is a 5-point Likert scale with a total of 28 Questions to identify the perceived QOL of the participants. There are four domains namely Physical Health, Psychological, Social and Environment domains with a maximum of 100.
- Body constitution questionnaires [ Time Frame: 9 months ]In 2009, the classification of body constitutions into nine specific types has been recognized by China Association of Chinese Medicine as the standard of body constitution (China Association of Chinese Medicine, 2009). Our research team also validated this questionnaire in Cantonese. The related version of questionnaire will be applied in this study. It is a self-rating scale with good reliability and validity. It contains nine subscales: gentleness, qi-deficiency, yang-deficiency, yin-deficiency, phlegm-dampness, dampness-heat, blood-stasis, qi-depression, and special diathesis. Score of each subscale is standardized from 0 to 100. Gentleness type is a balanced one with higher score indicating a better constitution status, while the other eight types are pathological types with higher score indicating worse constitution status.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04799743
|Contact: Zhong Linda, MD.,PH.Dfirstname.lastname@example.org|
|Kowloon Tong, Kowloon, Hong Kong|
|Contact: Linda Zhong, MD,PhD 34116523 email@example.com|
|Study Director:||Bian Zhaoxiang, MD.,PH.D||Hong Kong Chinese Medicine Clinical Study Centre|