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

China-Japan Friendship Hospital

Status: Enrolling

Conditions: COVID-19 Pneumonia

Treatments: Other: conventional western medicine treatment; Drug: Dexamethasone oral tablet; Other: Traditional Chinese medicine decoction

Study type: Interventional

Funder types: Other

Identifiers

NCT05798195

2023-ZF-3

Details and patient eligibility

About

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.

Enrollment: 420 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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420 participants in 3 patient groups

controlled group

Active Comparator group

Description:

conventional western medicine treatment including oxygen therapy, antibiotics, nebulization therapy, etc.

Treatment:

Other: conventional western medicine treatment

dexamethasone group

Experimental group

Description:

dexamethasone 1.5mg/day for one week and 0.75mg/day for another week basing on conventional western medicine.

Treatment:

Drug: Dexamethasone oral tablet

Other: conventional western medicine treatment

Chinese medicine group

Experimental group

Description:

Strengthening spleen and tonifying lung decoction for 2 weeks basing on conventional western medicine.

Treatment:

Other: conventional western medicine treatment

Other: Traditional Chinese medicine decoction