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

Sponsor

China-Japan Friendship Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05798195

Collaborator

(none)

420

Enrollment

Location

Arms

Anticipated Duration (Months)

17.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
COVID-19 Pneumonia	Other: conventional western medicine treatment Drug: Dexamethasone oral tablet Other: Traditional Chinese medicine decoction	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

420 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

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.

Actual Study Start Date :

Jan 1, 2023

Anticipated Primary Completion Date :

Dec 31, 2024

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Lung CT scan [1 month]
compared with base,≥90% pneumonia obsorbed

Secondary Outcome Measures

Lung CT scan [3 months]
compared with base,≥50% pneumonia obsorbed

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	China-Japan Friendship Hospital	Beijing	Beijing	China	100029

Sponsors and Collaborators

China-Japan Friendship Hospital

Investigators

Principal Investigator: Zhenguo Zhai, Dcotor, Department of Respiratory and Critical Care Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Zhenguo Zhai,MD,PhD, Chief physician of PCCM, China-Japan Friendship Hospital

ClinicalTrials.gov Identifier:

NCT05798195

Other Study ID Numbers:

2023-ZF-3

First Posted:

Apr 4, 2023

Last Update Posted:

Apr 4, 2023

Last Verified:

Apr 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

COVID-19

Pneumonia

Dexamethasone

Study Results

No Results Posted as of Apr 4, 2023