Traditional Chinese Medicine for Severe COVID-19
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|ClinicalTrials.gov Identifier: NCT04323332|
Recruitment Status : Not yet recruiting
First Posted : March 26, 2020
Last Update Posted : March 26, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|COVID-19||Drug: Traditional Chinese Medicine Prescription||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Retrospective Cohort Study to Evaluate the Efficacy and Safety of Traditional Chinese Medicine as an Adjuvant Treatment for Patients With Severe COVID-19|
|Estimated Study Start Date :||March 2020|
|Estimated Primary Completion Date :||March 2020|
|Estimated Study Completion Date :||April 2020|
Experimental: Traditional Chinese Medicine
TCM prescription and conventional treatments
Drug: Traditional Chinese Medicine Prescription
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.
No Intervention: Control
- 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 [ Time Frame: 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 [ Time Frame: First treatment date up to 3 months ]
- Blood immune cell count [ Time Frame: Baseline, 7 and/ or 14 days ]Changes in leukocyte, neutral, lymphocyte counts and absolute lymphocyte count from baseline
- Serum inflammatory markers [ Time Frame: 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 [ Time Frame: Baseline, 7 and/ or 14 days ]Changes in erythrocyte sedimentation rate from baseline.
- Platelet and D-dimer changes [ Time Frame: Baseline, 7 and/ or 14 days ]Changes in platelets and D-dimers from baseline.
- Creatinine changes [ Time Frame: Baseline, 7 and/ or 14 days ]Changes in serum creatinine from baseline.
- Muscle enzymes changes [ Time Frame: Baseline, 7 and/ or 14 days ]Changes in serum muscle enzymes from baseline, including alanine aminotransferase , AST, creatine kinase, LDH.
- Usage of antibiotics [ Time Frame: First treatment date up to 3 months ]Dosing time and amounts of antibiotics；the categories of the antibiotics
- Usage of glucocorticoids [ Time Frame: First treatment date up to 3 months ]Dosing time and amounts of glucocorticoids
- Frequency of adverse events [ Time Frame: First treatment date up to 3 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04323332
|Contact: Hao Li, Professoremail@example.com|
|Beijing, Beijing, China, 100091|
|Contact: Hao Li, Prof. 01062835088 firstname.lastname@example.org|
|Study Chair:||Hao Li, Professor||Xiyuan Hospital of China Academy of Chinese Medical Sciences|