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

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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COVID-19 Pneumonia

Intervention / Treatment
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* Other: conventional western medicine treatment
* Drug: Dexamethasone oral tablet
* Other: Traditional Chinese medicine decoction


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: controlled group<br>conventional western medicine treatment including oxygen therapy, antibiotics, nebulization therapy, etc. | Other: conventional western medicine treatment<br>* conventional western medicine treatment only<br>|
| Experimental: dexamethasone group<br>dexamethasone 1.5mg/day for one week and 0.75mg/day for another week basing on conventional western medicine. | Other: conventional western medicine treatment<br>* conventional western medicine treatment only<br>Drug: Dexamethasone oral tablet<br>* treat with Dexamethasone for 2 weeks<br>|
| Experimental: Chinese medicine group<br>Strengthening spleen and tonifying lung decoction for 2 weeks basing on conventional western medicine. | Other: conventional western medicine treatment<br>* conventional western medicine treatment only<br>Other: Traditional Chinese medicine decoction<br>* treat with strengthening spleen and tonifying lung decoction for 2 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lung CT scan | compared with base,≥90% pneumonia obsorbed | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lung CT scan | compared with base,≥50% pneumonia obsorbed | 3 months |