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

Not Applicable

Recruiting

• Conditions: COVID-19 Pneumonia
• Interventions: Other: conventional western medicine treatment; Drug: Dexamethasone oral tablet; Other: Traditional Chinese medicine decoction

• Registration Number: NCT05798195
• Lead Sponsor: China-Japan Friendship Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-01
• Status Verified: 2023-04
• Study First Submitted: 2023-04-02
• Study First Submitted QC: 2023-04-02
• Last Update Submitted: 2023-04-02
• Study First Posted: 2023-04-04
• Last Update Posted: 2023-04-04
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 420

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
dexamethasone group	Dexamethasone oral tablet	dexamethasone 1.5mg/day for one week and 0.75mg/day for another week basing on conventional western medicine.
Chinese medicine group	conventional western medicine treatment	Strengthening spleen and tonifying lung decoction for 2 weeks basing on conventional western medicine.
Chinese medicine group	Traditional Chinese medicine decoction	Strengthening spleen and tonifying lung decoction for 2 weeks basing on conventional western medicine.
dexamethasone group	conventional western medicine treatment	dexamethasone 1.5mg/day for one week and 0.75mg/day for another week basing on conventional western medicine.
controlled group	conventional western medicine treatment	conventional western medicine treatment including oxygen therapy, antibiotics, nebulization therapy, etc.

Primary Outcome Measures

Name	Time	Method
Lung CT scan	1 month	compared with base,≥90% pneumonia obsorbed

Secondary Outcome Measures

Name	Time	Method
Lung CT scan	3 months	compared with base,≥50% pneumonia obsorbed

Trial Locations

Locations (1)

China-Japan Friendship Hospital; 🇨🇳 Beijing, Beijing, China