Clinical trial NCT04799743: The Anti-fibrotic Therapeutic Effects of Resveratrol for Discharged COVID-19 Patients
Official title: A Pilot Randomized Controlled Clinical Study of Resveratrol for Discharged COVID 19 Patients in Order to Evaluate Its Therapeutic Effects Against Fibrosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Covid-19
Keywords: rehabilitation
Chinese medicine
randomized controlled trial
Lead sponsor: Hong Kong Baptist University
Sponsor class: OTHER
Collaborators: name: Hospital Authority, Hong Kong
First posted: 2021-03-16
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, Double-Blind, Placebo-Controlled Parallel Group Clinical Trial
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: The handheld basic spirometry
timeFrame: 9 months
measure: PRO scores
timeFrame: 9 months
measure: Borg Category-Ratio 0-10 Scale
timeFrame: 9 months
Secondary outcomes:
measure: Lung Function Questionnaire with 6-min walk-test
timeFrame: 9 months
measure: the World Health Organization Quality of Life Brief Assessment [WHOQOL-BREF (HK)]
timeFrame: 9 months
measure: Body constitution questionnaires
timeFrame: 9 months
Other outcomes:
Locations:
city: Kowloon Tong
country: Hong Kong
facility: Linda Zhong
state: Kowloon
Study officials:
affiliation: Hong Kong Chinese Medicine Clinical Study Centre
name: Bian Zhaoxiang, MD.,PH.D
role: STUDY_DIRECTOR
References: