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Traditional Chinese Medicine for Severe COVID-19

Primary Purpose

COVID-19

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Traditional Chinese Medicine Prescription
Sponsored by
Xiyuan Hospital of China Academy of Chinese Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19 focused on measuring COVID-19, Traditional Chinese Medicine, Pneumonia, Coronavirus

Eligibility Criteria

undefined - 85 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hao Li

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Traditional Chinese Medicine

Control

Arm Description

TCM prescription and conventional treatments

conventional treatments

Outcomes

Primary Outcome Measures

Length of hospital stay (days)

Secondary Outcome Measures

Duration (days) of supplemental oxygenation
CT imaging changes
Mortality rate
Time to Clinical Improvement (TTCI)
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 to COVID-19 nucleic acid testing negativity in throat swab
Blood immune cell count
Changes in leukocyte, neutral, lymphocyte counts and absolute lymphocyte count from baseline
Serum inflammatory markers
Changes in blood interleukin-6, c-reactive protein,SS-A/Ro antibodies and serum ferritin from baseline.
Erythrocyte sedimentation rate
Changes in erythrocyte sedimentation rate from baseline.
Platelet and D-dimer changes
Changes in platelets and D-dimers from baseline.
Creatinine changes
Changes in serum creatinine from baseline.
Muscle enzymes changes
Changes in serum muscle enzymes from baseline, including alanine aminotransferase , AST, creatine kinase, LDH.
Usage of antibiotics
Dosing time and amounts of antibiotics；the categories of the antibiotics
Usage of glucocorticoids
Dosing time and amounts of glucocorticoids
Frequency of adverse events

Full Information

First Posted
March 8, 2020
Last Updated
March 24, 2020
Sponsor
Xiyuan Hospital of China Academy of Chinese Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT04323332
Brief Title
Traditional Chinese Medicine for Severe COVID-19
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 2020 (Anticipated)
Primary Completion Date
March 2020 (Anticipated)
Study Completion Date
April 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Xiyuan Hospital of China Academy of Chinese Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
COVID-19, Traditional Chinese Medicine, Pneumonia, Coronavirus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Traditional Chinese Medicine
Arm Type
Experimental
Arm Description
TCM prescription and conventional treatments
Arm Title
Control
Arm Type
No Intervention
Arm Description
conventional treatments
Intervention Type
Drug
Intervention Name(s)
Traditional Chinese Medicine Prescription
Intervention Description
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.
Primary Outcome Measure Information:
Title
Length of hospital stay (days)
Time Frame
First treatment date up to 3 months
Secondary Outcome Measure Information:
Title
Duration (days) of supplemental oxygenation
Time Frame
First treatment date up to 3 months
Title
CT imaging changes
Time Frame
First treatment date up to 3 months
Title
Mortality rate
Time Frame
First treatment date up to 3 months
Title
Time to Clinical Improvement (TTCI)
Time Frame
First treatment date up to 3 months
Title
The pneumonia severity index scores
Description
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
Title
Time to COVID-19 nucleic acid testing negativity in throat swab
Time Frame
First treatment date up to 3 months
Title
Blood immune cell count
Description
Changes in leukocyte, neutral, lymphocyte counts and absolute lymphocyte count from baseline
Time Frame
Baseline, 7 and/ or 14 days
Title
Serum inflammatory markers
Description
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
Title
Erythrocyte sedimentation rate
Description
Changes in erythrocyte sedimentation rate from baseline.
Time Frame
Baseline, 7 and/ or 14 days
Title
Platelet and D-dimer changes
Description
Changes in platelets and D-dimers from baseline.
Time Frame
Baseline, 7 and/ or 14 days
Title
Creatinine changes
Description
Changes in serum creatinine from baseline.
Time Frame
Baseline, 7 and/ or 14 days
Title
Muscle enzymes changes
Description
Changes in serum muscle enzymes from baseline, including alanine aminotransferase , AST, creatine kinase, LDH.
Time Frame
Baseline, 7 and/ or 14 days
Title
Usage of antibiotics
Description
Dosing time and amounts of antibiotics；the categories of the antibiotics
Time Frame
First treatment date up to 3 months
Title
Usage of glucocorticoids
Description
Dosing time and amounts of glucocorticoids
Time Frame
First treatment date up to 3 months
Title
Frequency of adverse events
Time Frame
First treatment date up to 3 months

10. Eligibility

Sex
All
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: Patients were diagnosed as severe COVID-19 according to the Coronavirus disease (COVID-19) Treatment Guidance (Six edition) Patients received a combined treatment of TCM and conventional therapy, or only conventional therapy. Key Exclusion Criteria: Age >85 years After cardiopulmonary resuscitation 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. Respiratory failure and need mechanical ventilation
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hao Li, Professor
Phone
+0086-133113382093
Email
xyhplihao1965@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hao Li, Professor
Organizational Affiliation
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Official's Role
Study Chair
Facility Information:
Facility Name
Hao Li
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100091
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hao Li, Prof.
Phone
01062835088
Email
xyhplihao1965@126.com

12. IPD Sharing Statement

Plan to Share IPD
Yes

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Traditional Chinese Medicine for Severe COVID-19

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