Traditional Chinese Medicine for Severe COVID-19

A Retrospective Cohort Study to Evaluate the Efficacy and Safety of Traditional Chinese Medicine as an Adjuvant Treatment for Patients With Severe COVID-19

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.

Study Overview

• Status: Unknown
• Conditions: COVID-19
• Intervention / Treatment: Drug: Traditional Chinese Medicine Prescription

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Hao Li, Professor; Phone Number: +0086-133113382093; Email: xyhplihao1965@126.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100091
      • Hao Li
      • Contact: Hao Li, Prof.; Phone Number: 01062835088; Email: xyhplihao1965@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 85 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Length of hospital stay (days)	First treatment date up to 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration (days) of supplemental oxygenation		First treatment date up to 3 months
CT imaging changes		First treatment date up to 3 months
Mortality rate		First treatment date up to 3 months
Time to Clinical Improvement (TTCI)		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.	First treatment date up to 3 months
Time to COVID-19 nucleic acid testing negativity in throat swab		First treatment date up to 3 months
Blood immune cell count	Changes in leukocyte, neutral, lymphocyte counts and absolute lymphocyte count from baseline	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.	Baseline, 7 and/ or 14 days
Erythrocyte sedimentation rate	Changes in erythrocyte sedimentation rate from baseline.	Baseline, 7 and/ or 14 days
Platelet and D-dimer changes	Changes in platelets and D-dimers from baseline.	Baseline, 7 and/ or 14 days
Creatinine changes	Changes in serum creatinine from baseline.	Baseline, 7 and/ or 14 days
Muscle enzymes changes	Changes in serum muscle enzymes from baseline, including alanine aminotransferase , AST, creatine kinase, LDH.	Baseline, 7 and/ or 14 days
Usage of antibiotics	Dosing time and amounts of antibiotics；the categories of the antibiotics	First treatment date up to 3 months
Usage of glucocorticoids	Dosing time and amounts of glucocorticoids	First treatment date up to 3 months
Frequency of adverse events		First treatment date up to 3 months

Collaborators and Investigators

• Sponsor: Xiyuan Hospital of China Academy of Chinese Medical Sciences
• Investigators: Study Chair: Hao Li, Professor, Xiyuan Hospital of China Academy of Chinese Medical Sciences

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2020
• Primary Completion (Anticipated): March 1, 2020
• Study Completion (Anticipated): April 1, 2020

Study Registration Dates

• First Submitted: March 8, 2020
• First Submitted That Met QC Criteria: March 24, 2020
• First Posted (Actual): March 26, 2020

Study Record Updates

• Last Update Posted (Actual): March 26, 2020
• Last Update Submitted That Met QC Criteria: March 24, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Pneumonia; Coronavirus; COVID-19; Traditional Chinese Medicine
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: 2020XLA015-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No