Traditional Chinese Medicine for Severe COVID-19

NCT ID: NCT04323332

Last Updated: 2020-03-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-31

Study Completion Date

2020-04-30

Brief Summary

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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

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Conditions

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COVID-19

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Traditional Chinese Medicine

TCM prescription and conventional treatments

Group Type EXPERIMENTAL

Traditional Chinese Medicine Prescription

Intervention Type 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.

Control

conventional treatments

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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.

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
Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xiyuan Hospital of China Academy of Chinese Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Li Hao

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hao Li, Professor

Role: STUDY_CHAIR

Xiyuan Hospital of China Academy of Chinese Medical Sciences

Locations

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Hao Li

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Central Contacts

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Hao Li, Professor

Role: CONTACT

+0086-133113382093

Facility Contacts

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Hao Li, Prof.

Role: primary

01062835088

Other Identifiers

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2020XLA015-1

Identifier Type: -

Identifier Source: org_study_id

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