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

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.

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.

Study Overview

• Status: Recruiting
• Conditions: COVID-19 Pneumonia
• Intervention / Treatment: Other: conventional western medicine treatment; Drug: Dexamethasone oral tablet; Other: Traditional Chinese medicine decoction

• Study Type: Interventional
• Enrollment (Anticipated): 420
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Wanmu Xie, Doctor; Phone Number: 86-10-84206246; Email: xiewanmu@126.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100029
      • Recruiting
      • China-Japan Friendship Hospital
      • Contact: Wanmu Xie, Doctor; Phone Number: 86-10-84206246; Email: xiewanmu@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: China-Japan Friendship Hospital
• Investigators: Principal Investigator: Zhenguo Zhai, Dcotor, Department of Respiratory and Critical Care Medicine

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Anticipated): December 31, 2024
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: April 2, 2023
• First Submitted That Met QC Criteria: April 2, 2023
• First Posted (Actual): April 4, 2023

Study Record Updates

• Last Update Posted (Actual): April 4, 2023
• Last Update Submitted That Met QC Criteria: April 2, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Lung Diseases; COVID-19; Pneumonia; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Dexamethasone
• Other Study ID Numbers: 2023-ZF-3

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No