Covid19 Clinical Trial
Official title:
Chinese Medicine for Residue Symptoms of COVID-19 Recovered Patients- A Double-blind, Randomized, Placebo-controlled Study
COVID-19 has spread rapidly and now affects all over the world. On 11 March 2020, coronavirus disease 2019 (COVID-19) was declared a global pandemic by the World Health Organization (WHO). Most of the infected people will develop mild to moderate illness, for example fever, cough, tiredness and joint pain etc. For some older people, and those with comorbidities like cardiovascular disease, diabetes, chronic respiratory disease, and malignancy are more likely to develop serious illness. Also long-term problems such as fatigue, breathlessness and joint pain experienced by survivors of COVID-19 after discharge from hospital. Some clinical and pharmacological studies have suggested Traditional Chinese Medicine (TCM) has achieved remarkable therapeutic effect for active COVID cases of different severity during SARS epidemic in 2003. Also, some studies shown that using Chinese medicine interventions together with conventional treatment is more effective than using the conventional treatment alone in treating chronic fatigue syndrome. Traditional Chinese Medicine (TCM) has a long history and played an important role in the prevention and treatment of several epidemic diseases. However, there is a lack of clinical study of using TCM to treat the residue symptom of COVID-19 recovered patients. COVID-19 recovered patients will be screened and randomized into TCM group or placebo group for 8 weeks and followed by a post-treatment visits at week 12.
Status | Recruiting |
Enrollment | 68 |
Est. completion date | June 30, 2023 |
Est. primary completion date | January 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Aged above 18; - Have fatigue and one more residue symptoms (e.g. dyspnoea, sleep disturbance, cough, loose stool, abdominal distension, loss of appetite, dizziness, etc.) at least 5 weeks after discharge - Patients are diagnosed with "lung-spleen qi deficiency"(????) and/or"dual deficiency of qi and yin"(????) by a Chinese Medicine Practitioner - Voluntary written consent. Exclusion Criteria: - Still being SARS-CoV-2 positive - Known severe medical conditions, such as cardiovascular, liver or renal dysfunction, diabetes mellitus, cancers, cerebrovascular diseases, blood system diseases; - Impaired hematological profile and liver / renal function; - No concomitant non-steroidal anti-inflammatory drugs (NSAIDs), steroids, antibiotics, prebiotics, probiotics within 4 weeks; - Known allergic history to any Chinese herbal medicines; - Known pregnancy or lactating. |
Country | Name | City | State |
---|---|---|---|
Hong Kong | The Chinese University of Hong Kong | Shatin |
Lead Sponsor | Collaborator |
---|---|
Chinese University of Hong Kong |
Hong Kong,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The Change of Fatigue Severity Score | Improvement of residue COVID-19 symptoms of fatigue after study treatment at week 8, using a 9-item scale which measures the severity of fatigue and its effect on a person's activities and lifestyle in patients with a variety of disorders. Scores range from 9 - 63; the higher the score, the greater fatigue severity. | 8 weeks | |
Secondary | Long Term Symptom Assessment | Self-reported long term COVID-19 symptoms For the symptom questionnaire, participants will be asked to report newly occurring and persistent symptoms, or any symptoms worse than before COVID 19 development. The symptom assessment has 5 scale, from none to very severe. | 8 weeks | |
Secondary | The Change of Fatigue Severity Score (FSS) | FSS is a 9 item scale which measures the severity of fatigue and its effect on a person's activities and lifestyle in patients with a variety of disorders. Scores range from 9-63; the higher the score, the greater fatigue severity. | 12 weeks | |
Secondary | Improvement of dyspnoea using modified British Medical Research Council (mMRC) dyspnoea scale | The mMRC scale is a five-category scale to characterize the level of dyspnoea with physical activity in which higher scores correspond with increased dyspnoea. | 8 weeks and 12weeks | |
Secondary | The change of EuroQol five-dimension five-level (EQ-5D-5L)5L) questionnaire and it's Visual Analogue Scale (VAS) | To evaluate patients quality of life (QoL) by using EQ-5D-5L, higher score better QoL. EuroQol Visual Analogue Scale assess generic health ranging from 0-100, higher score better health experience. | 8 weeks and 12weeks | |
Secondary | Pulmonary function assessment on FEV1, FVC, and FEV1/FVC ratio | FEV1, FVC, and FEV1/FVC ratio will be measured with the Air Next Spirometer (NuvoAir, Sweden) in combination with the mobile coaching system. The higher of FEV1/FVC ratio, the healthier of subjects. | 8 weeks | |
Secondary | Adverse event assessment | Any reported adverse event related to study treatment will be analyzed throughout the study. | 8 weeks and 12weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05047692 -
Safety and Immunogenicity Study of AdCLD-CoV19-1: A COVID-19 Preventive Vaccine in Healthy Volunteers
|
Phase 1 | |
Recruiting |
NCT04395768 -
International ALLIANCE Study of Therapies to Prevent Progression of COVID-19
|
Phase 2 | |
Terminated |
NCT04555096 -
A Trial of GC4419 in Patients With Critical Illness Due to COVID-19
|
Phase 2 | |
Completed |
NCT04508777 -
COVID SAFE: COVID-19 Screening Assessment for Exposure
|
||
Completed |
NCT04506268 -
COVID-19 SAFE Enrollment
|
N/A | |
Completed |
NCT04961541 -
Evaluation of the Safety and Immunogenicity of Influenza and COVID-19 Combination Vaccine
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT04546737 -
Study of Morphological, Spectral and Metabolic Manifestations of Neurological Complications in Covid-19 Patients
|
N/A | |
Not yet recruiting |
NCT04543006 -
Persistence of Neutralizing Antibodies 6 and 12 Months After a Covid-19
|
N/A | |
Completed |
NCT04494646 -
BARCONA: A Study of Effects of Bardoxolone Methyl in Participants With SARS-Corona Virus-2 (COVID-19)
|
Phase 2 | |
Terminated |
NCT04542993 -
Can SARS-CoV-2 Viral Load and COVID-19 Disease Severity be Reduced by Resveratrol-assisted Zinc Therapy
|
Phase 2 | |
Completed |
NCT04532294 -
Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2/COVID-19) Neutralizing Antibody in Healthy Participants
|
Phase 1 | |
Terminated |
NCT04581915 -
PHRU CoV01 A Trial of Triazavirin (TZV) for the Treatment of Mild-moderate COVID-19
|
Phase 2/Phase 3 | |
Not yet recruiting |
NCT04527211 -
Effectiveness and Safety of Ivermectin for the Prevention of Covid-19 Infection in Colombian Health Personnel
|
Phase 3 | |
Completed |
NCT04507867 -
Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III
|
N/A | |
Completed |
NCT04387292 -
Ocular Sequelae of Patients Hospitalized for Respiratory Failure During the COVID-19 Epidemic
|
N/A | |
Completed |
NCT04537663 -
Prevention Of Respiratory Tract Infection And Covid-19 Through BCG Vaccination In Vulnerable Older Adults
|
Phase 4 | |
Not yet recruiting |
NCT05038449 -
Study to Evaluate the Efficacy and Safety of Colchicine Tablets in Patients With COVID-19
|
N/A | |
Completed |
NCT04979858 -
Reducing Spread of COVID-19 in a University Community Setting: Role of a Low-Cost Reusable Form-Fitting Fabric Mask
|
N/A | |
Completed |
NCT04610502 -
Efficacy and Safety of Two Hyperimmune Equine Anti Sars-CoV-2 Serum in COVID-19 Patients
|
Phase 2 | |
Active, not recruiting |
NCT06042855 -
ACTIV-6: COVID-19 Study of Repurposed Medications - Arm G (Metformin)
|
Phase 3 |