NCT05798195

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
420

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 2, 2023

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 4, 2023

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

April 4, 2023

Status Verified

April 1, 2023

Enrollment Period

2 years

First QC Date

April 2, 2023

Last Update Submit

April 2, 2023

Conditions

COVID-19 Pneumonia

Outcome Measures

Primary Outcomes (1)

  • Lung CT scan

    compared with base,≥90% pneumonia obsorbed

    1 month

Secondary Outcomes (1)

  • Lung CT scan

    3 months

Study Arms (3)

controlled group

ACTIVE COMPARATOR

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

Other: conventional western medicine treatment

dexamethasone group

EXPERIMENTAL

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

Other: conventional western medicine treatmentDrug: Dexamethasone oral tablet

Chinese medicine group

EXPERIMENTAL

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

Other: conventional western medicine treatmentOther: Traditional Chinese medicine decoction

Interventions

conventional western medicine treatmentOTHER

conventional western medicine treatment only

Chinese medicine groupcontrolled groupdexamethasone group
Dexamethasone oral tabletDRUG

treat with Dexamethasone for 2 weeks

dexamethasone group
Traditional Chinese medicine decoctionOTHER

treat with strengthening spleen and tonifying lung decoction for 2 weeks

Chinese medicine group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of COVID-19 pneumonia；
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

China-Japan Friendship Hospital

Beijing, Beijing Municipality, 100029, China

RECRUITING

MeSH Terms

Interventions

Dexamethasone

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Officials

  • Zhenguo Zhai, Dcotor

    Department of Respiratory and Critical Care Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Wanmu Xie, Doctor

CONTACT

86-10-84206246xiewanmu@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief physician of PCCM

Study Record Dates

First Submitted

April 2, 2023

First Posted

April 4, 2023

Study Start

January 1, 2023

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

April 4, 2023

Record last verified: 2023-04

Locations

CN(1)