COVID-19 PneumoniaNCT05798195
Traditional Chinese Medicine or Low-dose Dexamethasone in COVID-19 Pneumonia
A study testing conventional western medicine treatment, Dexamethasone oral tablet and Traditional Chinese medicine decoction in people with COVID-19 Pneumonia, run by China-Japan Friendship Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19 Pneumonia
- What is being tested?
- conventional western medicine treatment, Dexamethasone oral tablet and Traditional Chinese medicine decoction
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 420 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029
Wanmu Xie, Doctor, 86-10-84206246, xiewanmu@126.com
About this study
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.
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.
- Conditions
- COVID-19 Pneumonia
- Being tested
- conventional western medicine treatment, Dexamethasone oral tablet, Traditional Chinese medicine decoction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional western medicine treatmentOther
conventional western medicine treatment only
Dexamethasone oral tabletDrug
treat with Dexamethasone for 2 weeks
Traditional Chinese medicine decoctionOther
treat with strengthening spleen and tonifying lung decoction for 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| controlled group | Active comparator | conventional western medicine treatment including oxygen therapy, antibiotics, nebulization therapy, etc. Receives: 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. Receives: Other: conventional western medicine treatment; Drug: Dexamethasone oral tablet |
| Chinese medicine group | Experimental | Strengthening spleen and tonifying lung decoction for 2 weeks basing on conventional western medicine. Receives: Other: conventional western medicine treatment; Other: Traditional Chinese medicine decoction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung CT scan
compared with base,≥90% pneumonia obsorbed
Measured: 1 month
Secondary outcomes (1)
Lung CT scan
compared with base,≥50% pneumonia obsorbed
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2023
- Study start1 Jan 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 PneumoniaStudies of the same condition, open and under way.
- More trials run by China-Japan Friendship HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 420 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China-Japan Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhenguo Zhai,MD,PhD, China-Japan Friendship Hospital
- Investigators
- Zhenguo Zhai, Dcotor, Principal investigator, Department of Respiratory and Critical Care Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05798195
- Sponsor's protocol ID
- 2023-ZF-3
- Status last verified
- Apr 2023
- First submitted
- 2 Apr 2023
- Last updated
- 4 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05798195
- Acronym / sponsor ID
- 2023-ZF-3
- Conditions
- COVID-19 Pneumonia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 420 participants (estimated)
- Lead sponsor
- China-Japan Friendship HospitalUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 4 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| controlled group | Active comparator | Other: conventional western medicine treatmentconventional western medicine treatment including oxygen therapy, antibiotics, nebulization therapy, etc. |
| dexamethasone group | Experimental | Other: conventional western medicine treatment, Drug: Dexamethasone oral tabletdexamethasone 1.5mg/day for one week and 0.75mg/day for another week basing on conventional western medicine. |
| Chinese medicine group | Experimental | Other: conventional western medicine treatment, Other: Traditional Chinese medicine decoctionStrengthening spleen and tonifying lung decoction for 2 weeks basing on conventional western medicine. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| conventional western medicine treatmentconventional western medicine treatment only | Other | Chinese medicine group, controlled group, dexamethasone group |
| Dexamethasone oral tablettreat with Dexamethasone for 2 weeks | Drug | dexamethasone group |
| Traditional Chinese medicine decoctiontreat with strengthening spleen and tonifying lung decoction for 2 weeks | Other | Chinese medicine group |
Primary outcome
Lung CT scan
Time frame: 1 month
compared with base,≥90% pneumonia obsorbed
1 secondary outcome
Lung CT scan
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhenguo Zhai, Dcotor principal investigator
Department of Respiratory and Critical Care Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing conventional western medicine treatment, Dexamethasone oral tablet and Traditional Chinese medicine decoction in people with COVID-19 Pneumonia, run by China-Japan Friendship Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wanmu Xie, Doctor (86-10-84206246, xiewanmu@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lung CT scan (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2023.