Traditional Chinese Medicine for Severe COVID-19
- Conditions
- COVID-19
- Interventions
- Drug: Traditional Chinese Medicine Prescription
- Registration Number
- NCT04323332
- Brief Summary
In December 2019, a new type of pneumonia, COVID-2019 outbroke in Wuhan ,China, and currently the infected has been reported in more than at least 75 countries.
Patients with severe COVID-19 have rapid disease progression and high mortality rate. This may attribute to the excessive immune response caused by cytokine storm. Strategies based on anti-virus drugs and treatments against symptoms have now been employed. However, these managements can't effectively treat the lethal lung injury and uncontrolled immune responses, especially in the elderly with severe COVID-19. Traditional Chinese Medicine (TCM), which treats the disease from anther perspective, has achieved satisfactory results. National Health Commission of China released a series of policies to enhance the administration of TCM prescriptions.
This study is aimed to evaluate the efficacy and safety of Traditional Chinese Medicine as an adjuvant treatment for severe COVID-19.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 50
- Patients were diagnosed as severe COVID-19 according to the Coronavirus disease (COVID-19) Treatment Guidance (Six edition)
- Patients received a combined treatment of TCM and conventional therapy, or only conventional therapy.
Key
- Age >85 years
- After cardiopulmonary resuscitation
- Patients combined with other organ failure or conditions need ICU monitoring and treatment, such as severe liver disease, severe renal dysfunction, upper gastrointestinal hemorrhage, disseminated intravascular coagulation.
- Respiratory failure and need mechanical ventilation
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Traditional Chinese Medicine Traditional Chinese Medicine Prescription TCM prescription and conventional treatments
- Primary Outcome Measures
Name Time Method Length of hospital stay (days) First treatment date up to 3 months
- Secondary Outcome Measures
Name Time Method Time to Clinical Improvement (TTCI) First treatment date up to 3 months CT imaging changes First treatment date up to 3 months Duration (days) of supplemental oxygenation First treatment date up to 3 months Mortality rate First treatment date up to 3 months The pneumonia severity index scores First treatment date up to 3 months The pneumonia severity index is a clinical tool helping in the risk stratification of patients with community-acquired pneumonia. It ranges from 0-395 scores and a higher score indicates higher death risk.
Time to COVID-19 nucleic acid testing negativity in throat swab First treatment date up to 3 months Blood immune cell count Baseline, 7 and/ or 14 days Changes in leukocyte, neutral, lymphocyte counts and absolute lymphocyte count from baseline
Serum inflammatory markers Baseline, 7 and/ or 14 days Changes in blood interleukin-6, c-reactive protein,SS-A/Ro antibodies and serum ferritin from baseline.
Erythrocyte sedimentation rate Baseline, 7 and/ or 14 days Changes in erythrocyte sedimentation rate from baseline.
Platelet and D-dimer changes Baseline, 7 and/ or 14 days Changes in platelets and D-dimers from baseline.
Creatinine changes Baseline, 7 and/ or 14 days Changes in serum creatinine from baseline.
Muscle enzymes changes Baseline, 7 and/ or 14 days Changes in serum muscle enzymes from baseline, including alanine aminotransferase , AST, creatine kinase, LDH.
Usage of antibiotics First treatment date up to 3 months Dosing time and amounts of antibiotics；the categories of the antibiotics
Usage of glucocorticoids First treatment date up to 3 months Dosing time and amounts of glucocorticoids
Frequency of adverse events First treatment date up to 3 months
Trial Locations
- Locations (1)
Hao Li
🇨🇳Beijing, Beijing, China