Pulmonary Fibrosis Due to COVID-19Phase 2NCT04279197
Treatment of Pulmonary Fibrosis Due to COVID-19 With Fuzheng Huayu
A Phase 2 study testing Fuzheng Huayu Tablet, Vitamin C tablets and respiratory function rehabilitation training in people with Pulmonary Fibrosis Due to COVID-19, run by ShuGuang Hospital at 1 site in China.
Trial summary
According to previous studies, viral pneumonia can develop into pulmonary fibrosis, which can affect patients'lung function and even life health.This study aims to observe the efficacy and safety of Fuzheng Huayu Tablets in the treatment of pulmonary fibrosis after COVID-19. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Pulmonary Fibrosis Due to COVID-19
- What is being tested?
- Fuzheng Huayu Tablet, Vitamin C tablets and respiratory function rehabilitation training
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 142 participants
- Where
- 1 siteChina
- Study dates
- 23 Apr 2020to 24 Mar 2021
- Phase
- Phase 2
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Patients who have undergone lung surgery that affects pulmonary function, such as pulmonary transplantation, pulmonary resection, pulmonary volume reduction, etc;
- Relying on mechanical ventilation to maintain pulmonary function, such as ventilators;
- Combined with chronic pulmonary diseases affecting pulmonary function, such as chronic obstructive pulmonary disease, other known causes of interstitial pulmonary disease;
- Patients with diseases affecting cardiac function, such as pulmonary circulation hypertension, heart failure, peripheral vascular disease, fibromyalgia, and pacemaker installation;
- Patients with severe underlying diseases affecting survival, including uncontroled cardiac, renal, digestive, hematological, neuropsychiatric, immune, metabolic diseases, malignant diseases and severe malnutrition;
- Resting heart rate >120 times/min;
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- Systolic blood pressure > 180 mmHg, diastolic blood pressure > 100 mmHg;
- Unstable angina pectoris or myocardial infarction occurring within the last month;
- Severe obesity (BMI > 30 kg/m2);
- Allergic constitution, allergic to the drug components involved in the treatment program;
- Pregnant or breastfeeding women;
- Patients with disabilities who are unable to complete the efficacy evaluation questionnaires;
- Difficult collaborators with poor mental health status, suffering from mental illness, patients without self-control, unable to express clearly;
- Those who are participating in other clinical trials;
- According to the investigator's judgment, patients whose enrollment complications or poor compliance will affect the efficacy and safety evaluation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Fuzheng Huayu Tablets in Post-COVID-19 Patients With Pulmonary Inflammation and Fibrosis : A Multicenter Double-blind Randomized Controlled Trial
According to previous studies, viral pneumonia can develop into pulmonary fibrosis, which can affect patients'lung function and even life health.This study aims to observe the efficacy and safety of Fuzheng Huayu Tablets in the treatment of pulmonary fibrosis after COVID-19.
Read the detailed description
The patients with COVID-19 could suffered from the pulmonary dysfunction and/or fibrosis the recovery period, but there are no certain drugs or treatment to cope with this situation. Our previous studies indicated that Fuzheng Huayu tablets (FZHY) could regress the lung fibrosis induced by bleomycin in animals, and improve the pulmonary function in the patients with chronic obstructive pulmonary disease. Now we design this trial to carry out the clinical study in order to evaluate the effects of Fuzheng Huayu tablets on pulmonary fibrosis and/or pulmonary function injury in the recovery period of COVID-19 and expect to improve the prognosis.
This is a randomized, double-blind, multicenter, placebo-controlled clinical trial.It enrolls 142 patients who had been diagnosed with COVID-19, but currently they are negative for viral testing and have developed pulmonary fibrosis or pulmonary dysfunction. They are randomly assigned into Placebo group and FZHY group. All patients are given usual treatment such as respiratory function rehabilitation training and vitamin C. The FZHY group is given Fuzheng Huayu tablets, and the control group is given placebo. Each patient will be observed for 24 weeks and followed up for 8 weeks. The primary outcomes for the trial are the improvement proportion of pulmonary fibrosis judged by HRCT score and the improvement of lung function(FVC,FEV1,FVC/FEV1). Secondary outcomes include six-minute walk distance, improvement proportion of pulmonary inflammation, improvement proportion of clinical symptoms , quality of Life-BREF (QOL-BREF) Score, patient health questionnaire-9 (PHQ-9) Score, general anxiety disorder-7 (GAD-7) score. The safety also be observed.
- Conditions
- Pulmonary Fibrosis Due to COVID-19
- Being tested
- Fuzheng Huayu Tablet, Vitamin C tablets, Placebo, respiratory function rehabilitation training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fuzheng Huayu TabletDrug
Also called FZHY
FZHY, administration: 0.4g/tablet, 1.6g/time, 3 times/day, oral; administered half an hour after the meal.
Vitamin C tabletsDrug
Also called VC
Vitamin C tablets, administration: 0.2g/time, 3 times/ day, oral；
PlaceboDrug
Placebo , administration: 0.4g/tablet, 1.6g/time, 3 times/day, oral; administered half an hour after the meal.
respiratory function rehabilitation trainingOther
Health exercise, once a day
| Study group | Role | What they receive |
|---|---|---|
| FZHY Group | Experimental | usual treatment (respiratory function rehabilitation training + Vitamin C tablets)
* Fuzheng Huayu tablets Receives: Drug: Fuzheng Huayu Tablet; Drug: Vitamin C tablets; Other: respiratory function rehabilitation training |
| Placebo Group | Placebo comparator | usual treatment (respiratory function rehabilitation training + Vitamin C tablets)
* placebo Receives: Drug: Vitamin C tablets; Drug: Placebo; Other: respiratory function rehabilitation training |
What is being measured
The primary outcome is the main question the study is designed to answer.
The improvement proportion of pulmonary fibrosis
Evaluation of pulmonary fibrosis Improvement. pulmonary fibrosis judged by HRCT score.HRCT images are divided into four grades according to the score, and a reduction of one grade is an improvement.
Measured: Week 24
The improvement of lung function
FVC, FEV1, FVC/FEV1
Measured: Week 24
Secondary outcomes (6)
The improvement proportion of pulmonary inflammation
Evaluation of pulmonary inflammation Improvement
Measured: Week 24
The improvement proportion of clinical symptom
Discomfort symptoms include dyspnea, cough, exhausted, fatigue, insomnia, sweating, poor appetite, diarrhea, etc., which are common manifestations of patients with COVID-19
Measured: Week 24
Quality of Life-BREF (QOL-BREF)
This scale can reflect the quality of life of patients to some extent.
Measured: Week 24
Patient Health Questionnaire-9(PHQ-9)
This scale can reflect the quality of life of patients to some extent.
Measured: Week 24
Generalized anxiety disorder-7(GAD-7)
This scale can reflect the quality of life of patients to some extent.
Measured: Week 24
The 6-minute walk distance
Evaluation of Lung Function Improvement
Measured: Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2020
- Study start23 Apr 2020
- Primary completion24 Mar 2021
- Study completion24 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Fibrosis Due to COVID-19Studies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- ShuGuang Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Hubei Hospital of Traditional Chinese Medicine, Jingmen No.1 People's Hospital, Wuhan No.1 Hospital, Wuhan Third Hospital, Huangshi Hospital of Traditional Chinese Medicine
- Responsible party
- Principal investigator, Liu Chenghai, ShuGuang Hospital
- Investigators
- Chenghai Liu, Study director, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04279197
- Sponsor's protocol ID
- Fzhy-ncp-2
- Status last verified
- Dec 2021
- First submitted
- 15 Feb 2020
- Last updated
- 3 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jing F, Wang W, Ke J, Huang T, Jiang B, Qiu Q, Huang J, Zhan S, Zhang W, Wu H, Su W, Feng J, Peng Y, Zhao Z, Xing F, Liu C. Fuzheng Huayu tablets for treating pulmonary fibrosis in post-COVID-19 patients: a multicenter, randomized, double-blind, placebo-controlled trial. Front Pharmacol. 2025 Mar 11;16:1508276. doi: 10.3389/fphar.2025.1508276. eCollection 2025.
PubMed 40135237
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Fuzheng Huayu Tablets in Post-COVID-19 Patients With Pulmonary Inflammation and Fibrosis : A Multicenter Double-blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04279197
- Acronym / sponsor ID
- Fzhy-ncp-2
- Conditions
- Pulmonary Fibrosis Due to COVID-19
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- ShuGuang HospitalUniversity, hospital or other
- Collaborators
- Hubei Hospital of Traditional Chinese Medicine, Jingmen No.1 People's Hospital, Wuhan No.1 Hospital, Wuhan Third Hospital, Huangshi Hospital of Traditional Chinese Medicine
- Study start
- 23 Apr 2020 (actual)
- Primary completion
- 24 Mar 2021 (actual)
- Study completion
- 24 Mar 2021 (actual)
- First posted
- 21 Feb 2020 (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.
According to previous studies, viral pneumonia can develop into pulmonary fibrosis, which can affect patients'lung function and even life health.This study aims to observe the efficacy and safety of Fuzheng Huayu Tablets in the treatment of pulmonary fibrosis after COVID-19.
Detailed description
The patients with COVID-19 could suffered from the pulmonary dysfunction and/or fibrosis the recovery period, but there are no certain drugs or treatment to cope with this situation. Our previous studies indicated that Fuzheng Huayu tablets (FZHY) could regress the lung fibrosis induced by bleomycin in animals, and improve the pulmonary function in the patients with chronic obstructive pulmonary disease. Now we design this trial to carry out the clinical study in order to evaluate the effects of Fuzheng Huayu tablets on pulmonary fibrosis and/or pulmonary function injury in the recovery period of COVID-19 and expect to improve the prognosis.
This is a randomized, double-blind, multicenter, placebo-controlled clinical trial.It enrolls 142 patients who had been diagnosed with COVID-19, but currently they are negative for viral testing and have developed pulmonary fibrosis or pulmonary dysfunction. They are randomly assigned into Placebo group and FZHY group. All patients are given usual treatment such as respiratory function rehabilitation training and vitamin C. The FZHY group is given Fuzheng Huayu tablets, and the control group is given placebo. Each patient will be observed for 24 weeks and followed up for 8 weeks. The primary outcomes for the trial are the improvement proportion of pulmonary fibrosis judged by HRCT score and the improvement of lung function(FVC,FEV1,FVC/FEV1). Secondary outcomes include six-minute walk distance, improvement proportion of pulmonary inflammation, improvement proportion of clinical symptoms , quality of Life-BREF (QOL-BREF) Score, patient health questionnaire-9 (PHQ-9) Score, general anxiety disorder-7 (GAD-7) score. The safety also be observed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FZHY Group | Experimental | Drug: Fuzheng Huayu Tablet, Drug: Vitamin C tablets, Other: respiratory function rehabilitation trainingusual treatment (respiratory function rehabilitation training + Vitamin C tablets) * Fuzheng Huayu tablets |
| Placebo Group | Placebo comparator | Drug: Vitamin C tablets, Drug: Placebo, Other: respiratory function rehabilitation trainingusual treatment (respiratory function rehabilitation training + Vitamin C tablets) * placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (15 listed)
- Patients who have undergone lung surgery that affects pulmonary function, such as pulmonary transplantation, pulmonary resection, pulmonary volume reduction, etc;
- Relying on mechanical ventilation to maintain pulmonary function, such as ventilators;
- Combined with chronic pulmonary diseases affecting pulmonary function, such as chronic obstructive pulmonary disease, other known causes of interstitial pulmonary disease;
- Patients with diseases affecting cardiac function, such as pulmonary circulation hypertension, heart failure, peripheral vascular disease, fibromyalgia, and pacemaker installation;
- Patients with severe underlying diseases affecting survival, including uncontroled cardiac, renal, digestive, hematological, neuropsychiatric, immune, metabolic diseases, malignant diseases and severe malnutrition;
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 |
|---|---|---|
| Fuzheng Huayu TabletAlso: FZHYFZHY, administration: 0.4g/tablet, 1.6g/time, 3 times/day, oral; administered half an hour after the meal. | Drug | FZHY Group |
| Vitamin C tabletsAlso: VCVitamin C tablets, administration: 0.2g/time, 3 times/ day, oral； | Drug | FZHY Group, Placebo Group |
| PlaceboPlacebo , administration: 0.4g/tablet, 1.6g/time, 3 times/day, oral; administered half an hour after the meal. | Drug | Placebo Group |
| respiratory function rehabilitation trainingHealth exercise, once a day | Other | FZHY Group, Placebo Group |
Primary outcome
The improvement proportion of pulmonary fibrosis
Time frame: Week 24
Evaluation of pulmonary fibrosis Improvement. pulmonary fibrosis judged by HRCT score.HRCT images are divided into four grades according to the score, and a reduction of one grade is an improvement.
The improvement of lung function
Time frame: Week 24
FVC, FEV1, FVC/FEV1
6 secondary outcomes
The improvement proportion of pulmonary inflammation
Time frame: Week 24
The improvement proportion of clinical symptom
Time frame: Week 24
Quality of Life-BREF (QOL-BREF)
Time frame: Week 24
Patient Health Questionnaire-9(PHQ-9)
Time frame: Week 24
Generalized anxiety disorder-7(GAD-7)
Time frame: Week 24
The 6-minute walk distance
Time frame: Week 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2022.
- Derived from this study: PubMed 40135237Jing F, Wang W, Ke J, Huang T, Jiang B, Qiu Q, Huang J, Zhan S, Zhang W, Wu H, Su W, Feng J, Peng Y, Zhao Z, Xing F, Liu C. Fuzheng Huayu tablets for treating pulmonary fibrosis in post-COVID-19 patients: a multicenter, randomized, double-blind, placebo-controlled trial. Front Pharmacol. 2025 Mar 11;16:1508276. doi: 10.3389/fphar.2025.1508276. eCollection 2025.
- Individual participant dataSharing planned: No
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.
Chenghai Liu study director
Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fuzheng Huayu Tablet, Vitamin C tablets and respiratory function rehabilitation training in people with Pulmonary Fibrosis Due to COVID-19, run by ShuGuang 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 0 inclusion and 15 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: finished, as of the sponsor's last update on 3 Jan 2022. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The improvement proportion of pulmonary fibrosis (time frame: Week 24). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04279197, which also lists 1 linked publication.
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 3 Jan 2022.