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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04323332
Recruitment Status : Unknown
Verified March 2020 by Li Hao, Xiyuan Hospital of China Academy of Chinese Medical Sciences.
Recruitment status was:  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

Tracking Information
First Submitted Date  ICMJE March 8, 2020
First Posted Date  ICMJE March 26, 2020
Last Update Posted Date March 26, 2020
Estimated Study Start Date  ICMJE March 2020
Estimated Primary Completion Date March 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 24, 2020)
Length of hospital stay (days) [ Time Frame: First treatment date up to 3 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 24, 2020)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Traditional Chinese Medicine for Severe COVID-19
Official Title  ICMJE A Retrospective Cohort Study to Evaluate the Efficacy and Safety of Traditional Chinese Medicine as an Adjuvant Treatment for Patients With Severe COVID-19
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE COVID-19
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: Traditional Chinese Medicine
    TCM prescription and conventional treatments
    Intervention: Drug: Traditional Chinese Medicine Prescription
  • No Intervention: Control
    conventional treatments
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: March 24, 2020)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2020
Estimated Primary Completion Date March 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 85 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04323332
Other Study ID Numbers  ICMJE 2020XLA015-1
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Current Responsible Party Li Hao, Xiyuan Hospital of China Academy of Chinese Medical Sciences
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Xiyuan Hospital of China Academy of Chinese Medical Sciences
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Hao Li, Professor Xiyuan Hospital of China Academy of Chinese Medical Sciences
PRS Account Xiyuan Hospital of China Academy of Chinese Medical Sciences
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP