Traditional Chinese Medicine or Low-dose Dexamethasone in COVID-19 Pneumonia

COVID-19 Pneumonia Clinical Trial

Official title:

Traditional Chinese Medicine or Low-dose Dexamethasone in Symptomatic Patients With Post-COVID-19 Parenchymal Lung Abnormalities: a Randomized Controlled Trial Three Arm, Parallel Group, Single Blind, Randomized Controlled Trial.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05798195
• Other study ID #: 2023-ZF-3
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2023
• Source: China-Japan Friendship Hospital
• Contact: Wanmu Xie, Doctor
• Phone: 86-10-84206246
• Email: xiewanmu[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this type of clinical trial is to learn about symptomatic patients with post-COVID-19 parenchymal lung abnormalities. The main questions it aims to answer are: the efficacy and safety of low-dose dexamethasone or traditional Chinese medicine in symptomatic patients with post-COVID-19 parenchymal lung abnormalities.

Participants will be divided into three parallel groups：controlled group with conventional western medicine treatment including oxygen therapy, antibiotics, nebulization therapy, etc. dexamethasone group: dexamethasone 1.5mg/day for one week and 0.75mg/day for another week basing on conventional western medicine. Chinese medicine group: Strengthening spleen and tonifying lung decoction for 2 weeks basing on conventional western medicine.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 420
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Clinical diagnosis of COVID-19 pneumonia;

• 3 to 8 weeks after the onset of the first symptoms of COVID-19 infection;

• Modified Medical Research Council (mMRC) score ?2 or hypoxemia;

• Imaging severity assessment of pneumonia: CT severity scores (CTSS):=5;

• Signed the informed consent.

Exclusion Criteria:

• Participants still admitted to intensive care unit at the time of enrollment;

• Known prior structural lung disease, including pulmonary fibrosis, severe COPD, severe bronchiectasis, and lung destruction;

• Taking glucocorticoids or immunosuppressants because of other chronic diseases;

• Contraindications of glucocorticoid;

• Heart failure(NYHA III or IV);

• Participants with renal replacement therapy;

• Psychiatric disorders or cognitive impairments;

• The expected survival time is less than six months due to diseases other than COVID-19 pneumonia.

Related Conditions & MeSH terms

• COVID-19
• COVID-19 Pneumonia
• Pneumonia

Intervention

Other:
• conventional western medicine treatment
conventional western medicine treatment only

Drug:
• Dexamethasone oral tablet
treat with Dexamethasone for 2 weeks

Other:
• Traditional Chinese medicine decoction
treat with strengthening spleen and tonifying lung decoction for 2 weeks

Locations

Country	Name	City	State
China	China-Japan Friendship Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
China-Japan Friendship Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lung CT scan	compared with base,=90% pneumonia obsorbed	1 month
Secondary	Lung CT scan	compared with base,=50% pneumonia obsorbed	3 months