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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Traditional Chinese Medicine Prescriptions have been recommended according to the Guidelines for the treatment of COVID-19 issued by National Health Commission of the PRC.
Hao Li
Beijing, Beijing Municipality, China
Length of hospital stay (days)
Time frame: First treatment date up to 3 months
Duration (days) of supplemental oxygenation
Time frame: First treatment date up to 3 months
CT imaging changes
Time frame: First treatment date up to 3 months
Mortality rate
Time frame: First treatment date up to 3 months
Time to Clinical Improvement (TTCI)
Time frame: First treatment date up to 3 months
The pneumonia severity index scores
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 frame: First treatment date up to 3 months
Time to COVID-19 nucleic acid testing negativity in throat swab
Time frame: First treatment date up to 3 months
Blood immune cell count
Changes in leukocyte, neutral, lymphocyte counts and absolute lymphocyte count from baseline
Time frame: Baseline, 7 and/ or 14 days
Serum inflammatory markers
Changes in blood interleukin-6, c-reactive protein,SS-A/Ro antibodies and serum ferritin from baseline.
Time frame: Baseline, 7 and/ or 14 days
Erythrocyte sedimentation rate
Changes in erythrocyte sedimentation rate from baseline.
Time frame: Baseline, 7 and/ or 14 days
Platelet and D-dimer changes
Changes in platelets and D-dimers from baseline.
Time frame: Baseline, 7 and/ or 14 days
Creatinine changes
Changes in serum creatinine from baseline.
Time frame: Baseline, 7 and/ or 14 days
Muscle enzymes changes
Changes in serum muscle enzymes from baseline, including alanine aminotransferase , AST, creatine kinase, LDH.
Time frame: Baseline, 7 and/ or 14 days
Usage of antibiotics
Dosing time and amounts of antibiotics；the categories of the antibiotics
Time frame: First treatment date up to 3 months
Usage of glucocorticoids
Dosing time and amounts of glucocorticoids
Time frame: First treatment date up to 3 months
Frequency of adverse events
Time frame: First treatment date up to 3 months
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