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

NCT04799743 | Unknown DMC

• 1 other identifier: HKCOVID19Resveratrol
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid-19

Keywords

rehabilitation; Chinese medicine; randomized controlled trial

Outcome Measures

Primary Outcomes (3)

• The handheld basic spirometry

  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

  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

  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 Outcomes (3)

• Lung Function Questionnaire with 6-min walk-test

  9 months

• the World Health Organization Quality of Life Brief Assessment [WHOQOL-BREF (HK)]

  9 months

• Body constitution questionnaires

  9 months

Study Arms (2)

Resveratrol group

EXPERIMENTAL

Resveratrol group (treatment group) will be instructed to consume with capsules (1.0 g, orally once a day) for six months.

Drug: Resveratrol

Placebo group

PLACEBO COMPARATOR

Placebo group (control group) will be instructed to orally take placebo (edible paraffin, 1.0) once a day.

Drug: Placebo capsules

Interventions

Resveratrol DRUG

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.

Also known as: Resveratrol Capsule

Resveratrol group

Placebo capsules DRUG

The placebo consist of mainly starch and microcrystalline cellulose, the usage and dosage are the same as the investigational drug.

Also known as: Study drug

Placebo group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hong Kong Baptist University: lead
• Hospital Authority, Hong Kong: collaborator

Study Sites (1)

Linda Zhong

Kowloon Tong, Kowloon, Hong Kong

RECRUITING

MeSH Terms

Conditions

COVID-19

Interventions

Resveratrol; Drug Evaluation

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Stilbestrols; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polyphenols; Phenols; Drug Development; Investigative Techniques; Evaluation Studies as Topic

Study Officials

• Bian Zhaoxiang, MD.,PH.D

  Hong Kong Chinese Medicine Clinical Study Centre

  STUDY DIRECTOR

Central Study Contacts

Zhong Linda, MD.,PH.D

CONTACT

852-34116523; ldzhong0305@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Randomized, Double-Blind, Placebo-Controlled Parallel Group Clinical Trial

Study Record Dates

• First Submitted: March 10, 2021
• First Posted: March 16, 2021
• Study Start: April 1, 2021
• Primary Completion: May 1, 2022
• Study Completion: May 1, 2022
• Last Updated: July 16, 2021

Record last verified: 2021-07

Locations

HK (1)