Treatment of Pulmonary Fibrosis Due to 2019-nCoV Pneumonia With Fuzheng Huayu
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|ClinicalTrials.gov Identifier: NCT04279197|
Recruitment Status : Recruiting
First Posted : February 21, 2020
Last Update Posted : February 21, 2020
|Condition or disease||Intervention/treatment||Phase|
|Pulmonary Fibrosis Due to 2019-nCoV||Drug: N-acetylcysteine+ Fuzheng Huayu Tablet Drug: N-acetylcysteine+Placebo||Phase 2|
Corona Virus Disease 2019, which began in December 2019 in Wuhan, Hubei province, has spread rapidly and become an international public health emergency. Although the pathological mechanism of the pneumonia is unclear, some patients developed severe or critical condition due to the continuous development of inflammation.
Inflammation is the early stage of fibrosis. After the control of acute symptoms and signs, severe patients often have more manifestations of pulmonary fibrosis, which affects the recurrence of lung function. Fuzheng Huayu tablets has been proved effective in inhibiting MMP activity to protect subepithelial basement membrane which plays a key role in lung injury and interstitial fibrosis.
This is a randomized, double blind, multicenter clinical study of pulmonary fibrosis due to 2019-nCoV. The main objective is to evaluate the safety and efficacy of Fuzheng Huayu in pulmonary fibrosis after 2019-nCoV infection.
In this study, 136 eligible patients with pulmonary fibrosis due to 2019-nCoV infection will be randomly assigned to one of two treatment groups at a 1:1 ratio. Patients will receive one of two treatment regimens: A. Fuzheng Huayu tablets + basic treatment; B. Placebo tablets + basic treatment. The basic treatment includes N-acetylcysteine 1 capsule three times a day.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||136 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Randomized, Placebo-Controlled, Multi-Center Study on the Efficacy and Safety of Fuzheng Huayu on Pulmonary Fibrosis Due to 2019-nCoV|
|Estimated Study Start Date :||February 15, 2020|
|Estimated Primary Completion Date :||December 2022|
|Estimated Study Completion Date :||December 2022|
Experimental: Basic Treatment+Fuzheng Huayu Tablet
Capcule with N-acetylcysteine+ Tablet with Fuzheng Huayu
Drug: N-acetylcysteine+ Fuzheng Huayu Tablet
The subjects will be taking 1 N-acetylcysteine capcule and 4 Fuzheng Huayu tablets three times a day for 24 weeks.
Placebo Comparator: Basic Treatment+Placebo
Capcule with N-acetylcysteine+ Tablet with starch
The subjects will be taking 1 N-acetylcysteine capcule and 4 Placebo tablets three times a day for 24 weeks.
- High-resolution computed tomography (HRCT) score [ Time Frame: Week 24 ]Evaluation of Pulmonary fibrosis Improvement. HRCT images are graded from 1 to 6, higher scores mean a worse outcome.
- Lung function including FVC, FVC as a percentage of projected value and DLco [ Time Frame: Week 24 ]Evaluation of Lung Function Improvement
- Times of acute exacerbation [ Time Frame: Week 24 ]Times of acute exacerbations during treatment
- Six-minute walk distance [ Time Frame: Week 24 ]Measured by a 6-minute walking test
- Dyspnea Scores [ Time Frame: Week 24 ]Using the scale revised by British modified Medical Research Council (MMRC) which divided patients into five degrees.Higher scores mean a worse outcome.
- Composite physiological index [ Time Frame: Week 24 ]Evaluation of Pulmonary fibrosis Improvement on CT which is calculated by formula.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04279197
|Contact: Chenghai Liu, PhDemail@example.com|
|Shanghai, Shanghai, China, 201203|
|Contact: Chenghai Liu, PhD|