Treatment of Pulmonary Fibrosis Due to 2019-nCoV Pneumonia With Fuzheng Huayu

Study Purpose

Inflammation is the early stage of fibrosis. Serious patients are more likely to develop into pulmonary fibrosis, which affects the recurrence of lung function or even threatens life and health. This study is planned to observe the efficacy and safety of Fuzheng Huayu tablets in the treatment of pulmonary fibrosis after COVID-19.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 65 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Patients with pulmonary fibrosis after standard treatment of COVID-19 - Age 18-65 - 2019-nCoV nucleic acid negative in respiratory tract or blood samples were detected by real-time fluorescence PCR for more than 2 times - The patient did not participant in other drug clinical studies within 1 month.
  • - The patient or the patient's guardian agrees to participate the trial and sign the informed Consent Form

    Exclusion Criteria:

    - Gestation or lactation period women and women who plan to get pregnant during the study period - Those who are unable to communicate, such as patients in unconsciousness or with dementia, various mental , etc. - Severe background disease like severe cardiac insufficiency (cardiac function grade IV), severe liver and kidney diseases, bronchial asthma, COPD, neurological diseases, tumors,etc.
- Long-term bedridden for various reasons - Patient who are allergy to the experimental drug

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04279197
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

ShuGuang Hospital
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

OtherOtherOtherOther
Overall Status Recruiting
Countries China
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Pulmonary Fibrosis Due to 2019-nCoV
Additional Details

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.

Arms & Interventions

Arms

Experimental: Basic Treatment+Fuzheng Huayu Tablet

Capcule with N-acetylcysteine+ Tablet with Fuzheng Huayu

Placebo Comparator: Basic Treatment+Placebo

Capcule with N-acetylcysteine+ Tablet with starch

Interventions

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.

Drug: - N-acetylcysteine+Placebo

The subjects will be taking 1 N-acetylcysteine capcule and 4 Placebo tablets three times a day for 24 weeks.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Shuguang Hospital, Shanghai, Shanghai, China

Status

Recruiting

Address

Shuguang Hospital

Shanghai, Shanghai, 201203

Site Contact

Chenghai Liu, PhD

chenghailiu@hotmail.com

8621-20256521

Terms of Service

The PFF does not promote or represent that any investigational new drugs mentioned are safe or effective. The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. For a full description of terms please refer to our Terms, Conditions & Privacy.

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