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A Study to Evaluate the Efficacy and Safety of Pirfenidone With Novel Coronavirus Infection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT04282902
Recruitment Status : Unknown
Verified February 2020 by Huilan Zhang, Tongji Hospital.
Recruitment status was:  Recruiting
First Posted : February 25, 2020
Last Update Posted : February 25, 2020
Information provided by (Responsible Party):
Huilan Zhang, Tongji Hospital

Brief Summary:
The acute lung injury caused by SARS and 2003 were both related to the inflammatory cytokine storm in patients. The biochemical test showed abnormal increase in related indicators such as interleukin-8, and CT images showed a medical "white" lung". According to the experience of SARS treatment in 2003, the use of hormones will indeed help the patients to alleviate their illness, but patients who survived SARS either had too much hormone at that time and took too long. Although the lungs could recover, but the femoral head was necrotic Either the amount of hormones was very conservative at the time, which kept the lungs in the storm of inflammatory factors, leading to the emergence of irreversible pulmonary fibrosis. So is there a medicine that can anti-inflammatory, reduce the load of hormone use, and have the effect of treating and preventing pulmonary fibrosis complicated by severe viral lung? At present, pirfenidone has achieved encouraging results in the treatment of idiopathic Pulmonary Fibrosis (CTD-ILD) diseases. It is particularly encouraging that the values announced at the 2019 ATS Annual Conference suggest that pirfenidone has more anti-inflammatory and anti-oxidant effects than its own outstanding anti-fibrotic ability. The data shows early use, Its strong anti-SOD activity can effectively inhibit IL-1beta and IL-4, and can open the prevention mode of pulmonary interstitial fibrosis. Based on the above, this project intends to make the following scientific assumptions: based on the homology of the pathogens of the new coronavirus-infected pneumonia and the coronavirus infection of pneumonia in 2003, the similarities in the occurrence and development of the disease, that is, the pulmonary inflammatory storm occurs first, and thereafter The progress of fibrosis and the progressive decline of lung function and mortality are higher than those of ordinary pneumonia. We hope that by adding pirfenidone as a treatment program in addition to standard treatment, it will be a new and severe type of coronavirus infection. Patient clinical treatment provides an effective and practical method.

Condition or disease Intervention/treatment Phase
Novel Coronavirus Pneumonia Pneumonia Pirfenidone Drug: pirfenidone Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 294 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This study planned to randomize approximately 147 adult subjects. They will be stratified according to whether the onset time is ≤14 days and randomly divided into groups of 1: 1, receiving standard treatment or pirfenidone orally 3 times a day, 2 tablets each time. The course is 4 weeks or more. Subjects and all research center staff were not blinded.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Open-label Study to Evaluate the Efficacy and Safety of Pirfenidone in Patients With Severe and Critical Novel Coronavirus Infection
Actual Study Start Date : February 4, 2020
Estimated Primary Completion Date : April 30, 2020
Estimated Study Completion Date : June 1, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Pirfenidone

Arm Intervention/treatment
Experimental: Pirfenidone group
This study was designed to randomize approximately 147 adult subjects.The patients were stratified according to whether the onset time was less than 14 days, and randomly divided into groups at a ratio of 1:1. The group received pirfenidone orally three times a day, with two tablets each time, for a course of 4 weeks or longer.
Drug: pirfenidone
Pirfenidone is administered orally 3 times a day, 2 tablets each time, for a period of 4 weeks or longer

No Intervention: Standard treatment group
This study planned to randomize approximately 147 adult subjects. They will be stratified according to whether the onset time is ≤ 14 days and randomly divided into groups of 1: 1. This group only receives standard treatment

Primary Outcome Measures :
  1. chest CT [ Time Frame: 4 weeks ]
    Lesion area of chest CT image at 4 weeks

  2. Finger pulse oxygen [ Time Frame: 4 weeks ]
    Absolute change in pulse oxygen from baseline

  3. blood gas [ Time Frame: 4 weeks ]
    Absolute change in blood gas from baseline

  4. K-BILD [ Time Frame: 4 weeks ]
    Absolute change in total score of King's brief questionnaire for interstitial Absolute change in total score of King's brief questionnaire for interstitial pulmonary disease (k-bild) from baseline at week 4

Secondary Outcome Measures :
  1. death [ Time Frame: 4 weeks ]
    Time to death within 4 weeks due to respiratory problems

  2. Time to disease progression or death within 4 weeks [ Time Frame: 4 weeks ]
    Time to disease progression or death within 4 weeks

  3. blood [ Time Frame: 4 weeks ]
    lymphocyte count

  4. viral nucleic acid [ Time Frame: 4 weeks ]
    Absolute change in viral nucleic acid from baseline

  5. dyspnea score [ Time Frame: 4 weeks ]
    Pulmonary fibrosis survival symptoms absolute changes in dyspnea score from baseline

  6. blood [ Time Frame: 4 weeks ]
    changes in blood inflammatory indexes

  7. cough scores [ Time Frame: 4 weeks ]
    Absolute change in cough scores for pulmonary fibrosis survival symptoms from baseline

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

(1) Age ≥ 18 years. (2) Clinically diagnosed patients with new type of coronavirus pneumonia include: on the basis of meeting the criteria for suspected cases, one of the following pathogenic evidence: ① real-time fluorescent RT-PCR of respiratory specimens or blood specimens for detection of new coronavirus nucleic acid; Respiratory or blood specimens are genetically sequenced and highly homologous to known new coronaviruses. (3) The time interval between the suspected neocoronary pneumonia pneumonia case and the random enrollment is determined within 4 days to 7 days according to the history symptoms and chest CT imaging. Cough, diarrhea, or other related symptoms can be used. The imaging changes are mainly based on chest CT.

Exclusion Criteria:

(1) AST and ALT> 1.5 x ULN at visit 1; (2) bilirubin> 1.5 x ULN at visit 1; (3) creatinine clearance rate calculated by Cockcroft-Gault formula at visit 1 <30 mL / min; (4) patients with potential chronic liver disease (Child Pugh A, B or C liver injury; (5) previous treatment with nidanib or pirfenidone; (6) screening visits (interviews 1) Received other research drug treatment within 1 month or 6 half-lives (whichever is greater); (7) IPF diagnosis based on ATS / ERS / JRS / ALAT 2011 guidelines (P11-07084); (8 ) Significant pulmonary hypertension (PAH) defined by any of the following standards: ① Clinical / echocardiographic evidence of previously significant right heart failure; ② Medical history including right heart catheter showing a cardiac index ≤ 2l / min / m2; ③ Prostaglandol / qu Parenteral administration of prostacyclin in the treatment of PAH; (9) other clinically significant lung abnormalities considered by the investigator; (10) major extrapulmonary physiological limitations (such as chest wall deformity, large amount of pleural effusion); (11) Cardiovascular diseases, any of the following diseases: ① Severe hypertension within 6 months of Visit 1, uncontrollable after treatment (≥160 / 100 mmHg); ② myocardial infarction within 6 months of visit 1; ③ unstable angina within 6 months of visit 1; (12) history of severe central nervous system (CNS) events; (13) known trials Drug allergies; (14) Other diseases that may interfere with the testing process or as judged by the investigator may interfere with the trial participation or may put the patient at risk when participating in the trial; (15) Women who are pregnant, breastfeeding, or planning pregnancy in this trial (16) Patients are unable to understand or follow the trial procedures, including completing the questionnaires themselves without assistance.

Information from the National Library of Medicine

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): NCT04282902

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Contact: Huilan Zhang, PD 15391532171 huilanz_76@163.com
Contact: Jianping Zhao, PD 13507138234 Zhaojp88@126.com

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China, Hubei
Tongji hospital affiliated to huazhong university of science and technology Recruiting
Wuhan, Hubei, China
Contact: Huilan Zhang, PD         
Sponsors and Collaborators
Huilan Zhang
Publications of Results:
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Responsible Party: Huilan Zhang, Associate Professor of department of respiratory and critical care medicine, tongji hospital, Tongji Hospital
ClinicalTrials.gov Identifier: NCT04282902    
Other Study ID Numbers: huilanz_76
First Posted: February 25, 2020    Key Record Dates
Last Update Posted: February 25, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Coronavirus Infections
Respiratory Tract Infections
Lung Diseases
Respiratory Tract Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents