Clinical trial NCT04544605: Special Chinese Medicine Out-patient Programme for Discharged COVID-19 Patients
Official title: Special Chinese Medicine Out-patient Programme for Discharged COVID-19 Patients: An Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Post COVID-19
Keywords: COVID-19
Special Chinese Medicine Out-patient Programme
Discharged COVID-19 Patients Observational Study
Lead sponsor: Hong Kong Baptist University
Sponsor class: OTHER
Collaborators: name: The University of Hong Kong
name: Chinese University of Hong Kong
First posted: 2020-09-10
Enrollment: 150
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients at CMCTRs, previously diagnosed to be infected with COVID-19 and discharged from Hong Kong local hospitals.

Brief summary: According to the ongoing observational studies and the Chinese Medicine practice guideline for COVID-19 patients, the discharged patients with COVID-19 still exhibits certain clinical symptoms such as fatigue, poor appetite, short of breath, palpation, and poor sleep, which could be recognized as two main Patterns in Chinese Medicine, Qi Deficiency of Lung and Spleen and Qi \& Yin Deficiency. Based on this, pulmonary rehabilitation to improve lung function upon discharged was proposed. Therefore, even patients with COVID-19 were discharged from hospitals, there are symptoms with significant clinical syndromes in Chinese Medicine perspectives. These symptoms, in terms of syndrome, which could link with the body constitutions, could be due to pre-COVID-19 infection, suffering from infection, or a consequence of post-infection.

This observational study is a rehabilitation programme to elucidate i) whether body constitution is linking with the infection of COVID-19; ii) whether TCM can help the recovery of discharged COVID-19 patients.

Detailed description: This is an observational multi-centered study that will be conducted in the government subsidized tri-partite CM out-patient clinics (Chinese Medicine Clinic cum Training and Research Centres, "CMCTRs").

The study contains two parts as follows:

1. Retrospective Syndrome Survey: Retrospective information will be collected from participants using semi-structured interview and measuring the baseline body constitution before the rehabilitation treatment under the Programme, with the self-developed Body Constitutions Questionnaire.
2. TCM therapeutic assessment: The improvement of clinical symptoms and the status of body constitutions will be periodically evaluated.

Clinical CM Diagnostic Pattern \& clinical characteristics assessments, lung function tests, quality of life and no. of western medical consultations will be assessed at each visit for 9 months. Both retrospective and prospective assessments will be done for those participants who have already joined the Rehabilitation Program in CMCTRs.

Sample Size: Estimated at 150 participants.

Treatment of the Rehabilitation Program in CMCTRs:

The treatment is based on individual Chinese Medicine syndrome and clinical symptoms based on the Chinese Medicine practice guideline for COVID-19 patients. Two main Chinese medicine syndromes for patients recovered from COVID-19 with the recommended prescriptions will be included in the Rehabilitation Program.

the participants will receive three months individualized-Chinese herbal medicine treatment in CMCTRs. After the three months treatment, they are free to either continue another three-month treatment or enter into the follow-up period. Each participant will be assessed every month during the treatment and three months after treatment as follow-up.

Eligibility criteria: Inclusion Criteria:

* Participants under the COVID-19 Rehabilitation Program who have been previously diagnosed to be infected with COVID-19 and discharged from local hospitals after treatment with western medicine, with negative results from COVID-19 virus detection.

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 CHM allergies; 3) incompetent in giving consent.

Primary outcomes:
measure: Change in CM Diagnostic Pattern & Clinical Characteristics using CM Syndrome Differentiation Assessment
timeFrame: Change from Baseline the CM Diagnostic Pattern & Clinical Characteristics at 9 months
measure: Change in Body Constitution Scores using Body Constitution Questionnaires Assessment
timeFrame: Change from Baseline the Body Constitution at 9 months
Secondary outcomes:
measure: Lung Function Questionnaire in Lung Function Assessment
timeFrame: 9 months
measure: Blood Pressure in 6-minute Walk Test (6MWT)
timeFrame: 9 months
measure: Pulse in 6-minute Walk Test (6MWT)
timeFrame: 9 months
measure: SpO2 in 6-minute Walk Test (6MWT)
timeFrame: 9 months
measure: Distance Walked in 6-minute Walk Test (6MWT)
timeFrame: 9 months
measure: Number of Rests in 6-minute Walk Test (6MWT)
timeFrame: 9 months
measure: MRC Dyspnoea Scale in 6-minute Walk Test (6MWT)
timeFrame: 9 months
measure: Borg Scale of Perceived Exertion in 6-minute Walk Test (6MWT)
timeFrame: 9 months
measure: Peak Expiratory Flow (PEF) in Spirometry Assessment
timeFrame: 9 months
measure: Forced Expiratory Volume in 1 second (FEV1) in Spirometry Assessment
timeFrame: 9 months
measure: Force Vital Capacity (FVC) in Spirometry Assessment
timeFrame: 9 months
measure: FEV1/FVC ratio (%) in Spirometry Assessment
timeFrame: 9 months
measure: Quality of Life (WHO-QOL BREF HK)
timeFrame: 9 months
measure: Assessment on Western Medicine Visit Frequency
timeFrame: 9 months
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: School of Chinese Medicine, Hong Kong Baptist University
state: Hong Kong
Study officials:
affiliation: School of Chinese Medicine, LKS Faculty of Medicine, The University of Hong Kong
name: Yi Bin FENG, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: School of Chinese Medicine, The Chinese University of Hong Kong
name: Ching LIONG, PhD
role: PRINCIPAL_INVESTIGATOR
References: