A Retrospective Cohort Study to Evaluate the Efficacy and Safety of Traditional Chinese Medicine as an Adjuvant Treatment for Patients With Severe COVID-19
Trial Snapshot
- Phase
- Phase 3
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Length of hospital stay (days)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- — to 85 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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
Arms & Interventions
Traditional Chinese Medicine
TCM prescription and conventional treatments
Intervention: Traditional Chinese Medicine Prescription (Drug)
Outcomes
Primary Outcomes
Length of hospital stay (days)
Time Frame: First treatment date up to 3 months
Secondary Outcomes
- 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)
- 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)
- Serum inflammatory markers(Baseline, 7 and/ or 14 days)
- Erythrocyte sedimentation rate(Baseline, 7 and/ or 14 days)
- Platelet and D-dimer changes(Baseline, 7 and/ or 14 days)
- Creatinine changes(Baseline, 7 and/ or 14 days)
- Muscle enzymes changes(Baseline, 7 and/ or 14 days)
- Usage of antibiotics(First treatment date up to 3 months)
- Usage of glucocorticoids(First treatment date up to 3 months)
- Frequency of adverse events(First treatment date up to 3 months)
Investigators
Li Hao
professor
Xiyuan Hospital of China Academy of Chinese Medical Sciences