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The Anti-fibrotic Therapeutic Effects of Resveratrol for Discharged COVID-19 Patients (HKCOVID19Res)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04799743
Recruitment Status : Recruiting
First Posted : March 16, 2021
Last Update Posted : July 16, 2021
Sponsor:
Collaborator:
Hospital Authority, Hong Kong
Information provided by (Responsible Party):
Zhong Lidan, Hong Kong Baptist University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Covid-19 Drug: Resveratrol Drug: Placebo capsules Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
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.
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Drug Information available for: Resveratrol

Arm Intervention/treatment
Experimental: Resveratrol group
Resveratrol group (treatment group) will be instructed to consume with capsules (1.0 g, orally once a day) for six months.
Drug: Resveratrol
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




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

    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



Secondary Outcome Measures :
  1. 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).

  2. 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.

  3. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

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


Contacts
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Contact: Zhong Linda, MD.,PH.D 852-34116523 ldzhong0305@gmail.com

Locations
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Hong Kong
Linda Zhong Recruiting
Kowloon Tong, Kowloon, Hong Kong
Contact: Linda Zhong, MD,PhD    34116523    ldzhong0305@gmail.com   
Sponsors and Collaborators
Hong Kong Baptist University
Hospital Authority, Hong Kong
Investigators
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Study Director: Bian Zhaoxiang, MD.,PH.D Hong Kong Chinese Medicine Clinical Study Centre
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Responsible Party: Zhong Lidan, Assistant Professor, Hong Kong Baptist University
ClinicalTrials.gov Identifier: NCT04799743    
Other Study ID Numbers: HKCOVID19Resveratrol
First Posted: March 16, 2021    Key Record Dates
Last Update Posted: July 16, 2021
Last Verified: July 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zhong Lidan, Hong Kong Baptist University:
rehabilitation
Chinese medicine
randomized controlled trial
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Resveratrol
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Platelet Aggregation Inhibitors