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

July 10, 2021 updated by: Zhong Lidan, Hong Kong Baptist University

A Pilot Randomized Controlled Clinical Study of Resveratrol for Discharged COVID 19 Patients in Order to Evaluate Its Therapeutic Effects Against Fibrosis

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Hong Kong
    • Kowloon
      • Kowloon Tong, Kowloon, Hong Kong
        • Recruiting
        • Linda Zhong

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Study drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
9 months
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.
9 months
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
9 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
9 months
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.
9 months
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.
9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hong Kong Baptist University

Collaborators

Hospital Authority, Hong Kong

Investigators

  • Study Director: Bian Zhaoxiang, MD.,PH.D, Hong Kong Chinese Medicine Clinical Study Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 1, 2021

Primary Completion (ANTICIPATED)

May 1, 2022

Study Completion (ANTICIPATED)

May 1, 2022

Study Registration Dates

First Submitted

March 10, 2021

First Submitted That Met QC Criteria

March 15, 2021

First Posted (ACTUAL)

March 16, 2021

Study Record Updates

Last Update Posted (ACTUAL)

July 16, 2021

Last Update Submitted That Met QC Criteria

July 10, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HKCOVID19Resveratrol

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Covid-19

Clinical Trials on Placebo capsules

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Canada

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe