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Traditional Chinese Medicine for Severe COVID-19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04323332
Recruitment Status : Not yet recruiting
First Posted : March 26, 2020
Last Update Posted : March 26, 2020
Sponsor:
Information provided by (Responsible Party):
Li Hao, Xiyuan Hospital of China Academy of Chinese Medical Sciences

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.


Condition or disease Intervention/treatment Phase
COVID-19 Drug: Traditional Chinese Medicine Prescription Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Arm Intervention/treatment
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
conventional treatments



Primary Outcome Measures :
  1. Length of hospital stay (days) [ Time Frame: First treatment date up to 3 months ]

Secondary Outcome Measures :
  1. Duration (days) of supplemental oxygenation [ Time Frame: First treatment date up to 3 months ]
  2. CT imaging changes [ Time Frame: First treatment date up to 3 months ]
  3. Mortality rate [ Time Frame: First treatment date up to 3 months ]
  4. Time to Clinical Improvement (TTCI) [ Time Frame: First treatment date up to 3 months ]
  5. 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.

  6. Time to COVID-19 nucleic acid testing negativity in throat swab [ Time Frame: First treatment date up to 3 months ]
  7. Blood immune cell count [ Time Frame: Baseline, 7 and/ or 14 days ]
    Changes in leukocyte, neutral, lymphocyte counts and absolute lymphocyte count from baseline

  8. 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.

  9. Erythrocyte sedimentation rate [ Time Frame: Baseline, 7 and/ or 14 days ]
    Changes in erythrocyte sedimentation rate from baseline.

  10. Platelet and D-dimer changes [ Time Frame: Baseline, 7 and/ or 14 days ]
    Changes in platelets and D-dimers from baseline.

  11. Creatinine changes [ Time Frame: Baseline, 7 and/ or 14 days ]
    Changes in serum creatinine from baseline.

  12. 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.

  13. Usage of antibiotics [ Time Frame: First treatment date up to 3 months ]
    Dosing time and amounts of antibiotics;the categories of the antibiotics

  14. Usage of glucocorticoids [ Time Frame: First treatment date up to 3 months ]
    Dosing time and amounts of glucocorticoids

  15. Frequency of adverse events [ Time Frame: First treatment date up to 3 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   up to 85 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  1. Patients were diagnosed as severe COVID-19 according to the Coronavirus disease (COVID-19) Treatment Guidance (Six edition)
  2. Patients received a combined treatment of TCM and conventional therapy, or only conventional therapy.

Key Exclusion Criteria:

  1. Age >85 years
  2. After cardiopulmonary resuscitation
  3. 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.
  4. Respiratory failure and need mechanical ventilation

Information from the National Library of Medicine

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


Contacts
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Contact: Hao Li, Professor +0086-133113382093 xyhplihao1965@126.com

Locations
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China, Beijing
Hao Li
Beijing, Beijing, China, 100091
Contact: Hao Li, Prof.    01062835088    xyhplihao1965@126.com   
Sponsors and Collaborators
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Investigators
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Study Chair: Hao Li, Professor Xiyuan Hospital of China Academy of Chinese Medical Sciences
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Responsible Party: Li Hao, professor, Xiyuan Hospital of China Academy of Chinese Medical Sciences
ClinicalTrials.gov Identifier: NCT04323332    
Other Study ID Numbers: 2020XLA015-1
First Posted: March 26, 2020    Key Record Dates
Last Update Posted: March 26, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Li Hao, Xiyuan Hospital of China Academy of Chinese Medical Sciences:
COVID-19
Traditional Chinese Medicine
Pneumonia
Coronavirus