Traditional Chinese Medicine for Severe COVID-19

NCT04323332 | Unknown Phase 3

• 1 other identifier: 2020XLA015-1
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19

Keywords

COVID-19; Traditional Chinese Medicine; Pneumonia; Coronavirus

Outcome Measures

Primary Outcomes (1)

• Length of hospital stay (days)

  First treatment date up to 3 months

Secondary Outcomes (15)

• 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

  First treatment date up to 3 months

Study Arms (2)

Traditional Chinese Medicine

EXPERIMENTAL

TCM prescription and conventional treatments

Drug: Traditional Chinese Medicine Prescription

Control

NO INTERVENTION

conventional treatments

Interventions

Traditional Chinese Medicine Prescription DRUG

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.

Traditional Chinese Medicine

Eligibility Criteria

• Age: Up to 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Xiyuan Hospital of China Academy of Chinese Medical Sciences: lead

Study Sites (1)

Hao Li

Beijing, Beijing Municipality, 100091, China

Location

MeSH Terms

Conditions

COVID-19; Pneumonia; Coronavirus Infections

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Hao Li, Professor

  Xiyuan Hospital of China Academy of Chinese Medical Sciences

  STUDY CHAIR

Central Study Contacts

Hao Li, Professor

CONTACT

+0086-133113382093; xyhplihao1965@126.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: March 8, 2020
• First Posted: March 26, 2020
• Study Start: March 1, 2020
• Primary Completion: March 1, 2020
• Study Completion: April 1, 2020
• Last Updated: March 26, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

CN (1)