A Phase 3 interventional study of Traditional Chinese Medicine Prescription in COVID-19, sponsored by Xiyuan Hospital of China Academy of Chinese Medical Sciences. Status unknown at 1 site in China. Open to participants aged Up to 85 Years. Per ClinicalTrials.gov, last updated 2020-03-26.
Sponsored by Xiyuan Hospital of China Academy of Chinese Medical Sciences · Phase 3, Interventional, and Treatment
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.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's planned enrollment of 50 is below the median of 100 across 4,099 interventional studies indexed under COVID-19.
Browse COVID-19 studies →Xiyuan Hospital of China Academy of Chinese Medical Sciences is the lead sponsor of 41 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
TCM prescription and conventional treatments
Drug: Traditional Chinese Medicine Prescription
conventional treatments
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.
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
Plan to share: Yes
Supporting information: Study protocol
No publications or documents are linked to this record.
This study is status unknown, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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Xiyuan Hospital of China Academy of Chinese Medical Sciences