COVID-19NCT04334265
Efficacy and Safety of Anluohuaxian in the Treatment of Rehabilitation Patients With Corona Virus Disease 2019
A study testing Anluohuaxian in people with COVID-19, run by Peking University First Hospital at 9 sites in China.
Trial summary
To evaluate the efficacy and safety of Anluohuaxian in blocking the progression of pulmonary fibrosis and improving lung function in patients with COVID-19. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- COVID-19
- What is being tested?
- Anluohuaxian
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 750 participants
- Where
- 9 sitesChina
- Study dates
- 1 Apr 2020to 1 Dec 2020
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed COVID-19, and the nucleic acid test of respiratory specimens such as sputum or nasopharyngeal swabs is negative twice after the treatment (sampling interval is at least 24 hours);
- Negative nucleic acid test of respiratory specimens such as sputum or nasopharyngeal swabs during screening visits;
- High-resolution CT of the lung (HRCT) indicates pulmonary fibrosis (thickness of lobular septum, honeycomb-like changes, with or without bronchial / pleural distraction);
- Voluntarily participate in research and sign informed consent.
Who cannot join
- Combined with severe heart, lung (diagnosed with interstitial lung disease, bronchial asthma, chronic obstructive pulmonary disease, etc.), liver and kidney disease or with endocrine, rheumatic, neurologic, malignant and other systemic diseases;
- Have been diagnosed with connective tissue disease;
- Pregnant or lactating women;
- History of mental disorders, substance abuse or dependence;
- Have used other anti-pulmonary fibrosis drugs in the past 14 days, such as nidanib, pirfenidone, penicillamine, colchicine, tumor necrosis factor alpha blocker, imatinib, glucocorticoid hormones, morphomycodyl esters, azathioprine, cyclophosphamide, interferon-γ, and traditional Chinese medicine;
- Researchers consider it inappropriate to participate in research;
- Participating in other clinical research.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
China9 sites, 9 recruiting
- Not yet recruiting
The Second People's Hospital of Fuyang
Fuyang, Anhui, 230022
Xianfeng Han, 13955881280
- Not yet recruiting
Wenzhou Medical University Affiliated First Hospital
Wenzhou, Zhejiang, 325000
Yongping Chen, 13505777281
- Not yet recruiting
Ezhou Central Hospital
Wuhan, Hubei, 430000
Junhua Yu, 13908688619
- Not yet recruiting
Huoshenshan Hospital of Wuhan
Wuhan, Hubei, 430000
Sibin Zhang, 13911992121
- Recruiting
Jinyintan Hospital of Wuhan
Wuhan, Hubei, 430000
Dingyu Zhang, 13507117929
- Not yet recruiting
Tongji Hospital of Huazhong University of Science and Technology
Wuhan, Hubei, 430000
Qin Ning, 13971521450
- Not yet recruiting
West Hospital Union Hospital Huazhong University of Science and Technology
Wuhan, Hubei, 430000
Xi Zheng, 18602724981
- Not yet recruiting
Wuhan Pulmonary Hospital
Wuhan, Hubei, 430000
Xianxiang Chen, 18971570937
- Not yet recruiting
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, 430000
Zhenshun Cheng, 13627288300
About this study
Official title: Efficacy and Safety of Anluohuaxian in the Treatment of Rehabilitation Patients With Corona Virus Disease 2019-A Multicenter, Open, Randomized Controlled Study
To evaluate the efficacy and safety of Anluohuaxian in blocking the progression of pulmonary fibrosis and improving lung function in patients with COVID-19.
Read the detailed description
In clinical institutions that enroll patients with corona virus disease 2019, two arms, multi-center, randomized and controlled methods are adopted. Patients are divided into two groups, Anluohuaxian combined with regular treatment group and regular treatment group. 750 patients are expected to be enrolled and the cases are allocated according to the ratio of 2( Anluohuaxian combined with regular treatment group): 1(regular treatment group).
- Conditions
- COVID-19
- Being tested
- Anluohuaxian
- Keywords
- Anluohuaxian
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnluohuaxianDrug
6g each time, twice a day
| Study group | Role | What they receive |
|---|---|---|
| Anluohuaxian combined with regular treatment group | Experimental | Anluohuaxian: 6g each time, twice a day Receives: Drug: Anluohuaxian |
| regular treatment group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in high-resolution computer tomography of the lung
Changes in ground-glass shadows, interstitial or air nodules found on high-resolution computer tomography
Measured: 3 months
Change in 6-minute walking distance
Measured: 3 months
Secondary outcomes (4)
Changes in compound physiological index
Measured: 3 months
Changes in the scores of the St. George's Hospital Respiratory Questionnaire
St. George's Hospital Respiratory Questionnaire range from 0 to 100. 0 stands for no impact on life and 100 stands for extreme impact on life.
Measured: 3 months
Changes in modified British Medical Research Council Dyspnea Scale (mMRC) scores
mMRC score range from 0 to 4. 0 stands for wheezing only when exercising hard and 4 stands for severe breathing difficulties.
Measured: 3 months
Changes in vital capacity of the lung
Adult male vital capacity is about 3,500 ml and female is about 2,500 ml.
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 posted6 Apr 2020
- Study start1 Apr 2020
- Primary completion1 Jun 2020 (estimated)
- Study completion1 Dec 2020 (estimated)
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 COVID-19Studies of the same condition, open and under way.
- More trials run by Peking University First 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
- None (open label)
- Enrolment
- 750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guiqiang Wang, Peking University First Hospital
- Investigators
- Guiqiang Wang, Principal investigator, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04334265
- Sponsor's protocol ID
- 2020 research 110
- Status last verified
- Apr 2020
- First submitted
- 1 Apr 2020
- Last updated
- 24 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhang C, Li J, Wu Z, Wang H, Que C, Zhao H, Wang G. Efficacy and safety of Anluohuaxian in the treatment of patients with severe Coronavirus disease 2019- a multicenter, open label, randomized controlled study: a structured summary of a study protocol for a randomised controlled trial. Trials. 2020 Jun 8;21(1):495. doi: 10.1186/s13063-020-04399-8.
PubMed 32513299
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Anluohuaxian in the Treatment of Rehabilitation Patients With Corona Virus Disease 2019-A Multicenter, Open, Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04334265
- Acronym / sponsor ID
- 2020 research 110
- Conditions
- COVID-19
- Keywords
- Anluohuaxian
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 1 Jun 2020 (estimated)
- Study completion
- 1 Dec 2020 (estimated)
- First posted
- 6 Apr 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.
To evaluate the efficacy and safety of Anluohuaxian in blocking the progression of pulmonary fibrosis and improving lung function in patients with COVID-19.
Detailed description
In clinical institutions that enroll patients with corona virus disease 2019, two arms, multi-center, randomized and controlled methods are adopted. Patients are divided into two groups, Anluohuaxian combined with regular treatment group and regular treatment group. 750 patients are expected to be enrolled and the cases are allocated according to the ratio of 2( Anluohuaxian combined with regular treatment group): 1(regular treatment group).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anluohuaxian combined with regular treatment group | Experimental | Drug: AnluohuaxianAnluohuaxian: 6g each time, twice a day |
| regular treatment group | No intervention | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Confirmed COVID-19, and the nucleic acid test of respiratory specimens such as sputum or nasopharyngeal swabs is negative twice after the treatment (sampling interval is at least 24 hours);
- Negative nucleic acid test of respiratory specimens such as sputum or nasopharyngeal swabs during screening visits;
- High-resolution CT of the lung (HRCT) indicates pulmonary fibrosis (thickness of lobular septum, honeycomb-like changes, with or without bronchial / pleural distraction);
- Voluntarily participate in research and sign informed consent.
Key exclusion criteria (7 listed)
- Combined with severe heart, lung (diagnosed with interstitial lung disease, bronchial asthma, chronic obstructive pulmonary disease, etc.), liver and kidney disease or with endocrine, rheumatic, neurologic, malignant and other systemic diseases;
- Have been diagnosed with connective tissue disease;
- Pregnant or lactating women;
- History of mental disorders, substance abuse or dependence;
- Have used other anti-pulmonary fibrosis drugs in the past 14 days, such as nidanib, pirfenidone, penicillamine, colchicine, tumor necrosis factor alpha blocker, imatinib, glucocorticoid hormones, morphomycodyl esters, azathioprine, cyclophosphamide, interferon-γ, and traditional Chinese medicine;
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 |
|---|---|---|
| Anluohuaxian6g each time, twice a day | Drug | Anluohuaxian combined with regular treatment group |
Primary outcome
Changes in high-resolution computer tomography of the lung
Time frame: 3 months
Changes in ground-glass shadows, interstitial or air nodules found on high-resolution computer tomography
Change in 6-minute walking distance
Time frame: 3 months
4 secondary outcomes
Changes in compound physiological index
Time frame: 3 months
Changes in the scores of the St. George's Hospital Respiratory Questionnaire
Time frame: 3 months
Changes in modified British Medical Research Council Dyspnea Scale (mMRC) scores
Time frame: 3 months
Changes in vital capacity of the lung
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 24 Apr 2020.
- Derived from this study: PubMed 32513299Zhang C, Li J, Wu Z, Wang H, Que C, Zhao H, Wang G. Efficacy and safety of Anluohuaxian in the treatment of patients with severe Coronavirus disease 2019- a multicenter, open label, randomized controlled study: a structured summary of a study protocol for a randomised controlled trial. Trials. 2020 Jun 8;21(1):495. doi: 10.1186/s13063-020-04399-8.
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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.
Guiqiang Wang principal investigator
Peking University First Hospital
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anluohuaxian in people with COVID-19, run by Peking University First Hospital at 9 sites 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 4 inclusion and 7 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 24 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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 Guiqiang Wang (13911405123, john131212@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in high-resolution computer tomography of the lung (time frame: 3 months). 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 NCT04334265, 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 24 Apr 2020.