Traditional Chinese Medicine for Severe COVID-19

COVID-19 Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04323332
• Other study ID #: 2020XLA015-1
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: March 2020
• Est. completion date: April 2020

Study information

• Verified date: March 2020
• Source: Xiyuan Hospital of China Academy of Chinese Medical Sciences
• Contact: Hao Li, Professor
• Phone: +0086-133113382093
• Email: xyhplihao1965[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: April 2020
• Est. primary completion date: March 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19

Intervention

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.

Locations

Country	Name	City	State
China	Hao Li	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Xiyuan Hospital of China Academy of Chinese Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

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