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

NCT04282902 | Unknown Phase 3

• 1 other identifier: huilanz_76
• Study Type: interventional
• Target: 294
• Locations: 1 country
• Sites: 1

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.

Conditions

Novel Coronavirus Pneumonia; Pneumonia; Pirfenidone

Outcome Measures

Primary Outcomes (4)

• chest CT

  Lesion area of chest CT image at 4 weeks

  4 weeks

• Finger pulse oxygen

  Absolute change in pulse oxygen from baseline

  4 weeks

• blood gas

  Absolute change in blood gas from baseline

  4 weeks

• K-BILD

  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

  4 weeks

Secondary Outcomes (7)

• death

  4 weeks

• Time to disease progression or death within 4 weeks

  4 weeks

• blood

  4 weeks

• viral nucleic acid

  4 weeks

• dyspnea score

  4 weeks

Study Arms (2)

Pirfenidone group

EXPERIMENTAL

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

Standard treatment group

NO INTERVENTION

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

Interventions

pirfenidone DRUG

Pirfenidone is administered orally 3 times a day, 2 tablets each time, for a period of 4 weeks or longer

Pirfenidone group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• Huilan Zhang: lead

Study Sites (1)

Tongji hospital affiliated to huazhong university of science and technology

Wuhan, Hubei, China

RECRUITING

Related Publications (4)

• Dewage SNV, Organ L, Koumoundouros E, Derseh HB, Perera KUE, Samuel CS, Stent AW, Snibson KJ. The efficacy of pirfenidone in a sheep model of pulmonary fibrosis. Exp Lung Res. 2019 Nov-Dec;45(9-10):310-322. doi: 10.1080/01902148.2019.1695019. Epub 2019 Nov 25.

  PMID: 31762329 RESULT

• Lehmann M, Buhl L, Alsafadi HN, Klee S, Hermann S, Mutze K, Ota C, Lindner M, Behr J, Hilgendorff A, Wagner DE, Konigshoff M. Differential effects of Nintedanib and Pirfenidone on lung alveolar epithelial cell function in ex vivo murine and human lung tissue cultures of pulmonary fibrosis. Respir Res. 2018 Sep 15;19(1):175. doi: 10.1186/s12931-018-0876-y.

  PMID: 30219058 RESULT

• Ikeda S, Sekine A, Baba T, Katano T, Tabata E, Shintani R, Sadoyama S, Yamakawa H, Oda T, Okuda R, Kitamura H, Iwasawa T, Takemura T, Ogura T. Negative impact of anorexia and weight loss during prior pirfenidone administration on subsequent nintedanib treatment in patients with idiopathic pulmonary fibrosis. BMC Pulm Med. 2019 Apr 11;19(1):78. doi: 10.1186/s12890-019-0841-7.

  PMID: 30975118 RESULT

• Epstein Shochet G, Wollin L, Shitrit D. Fibroblast-matrix interplay: Nintedanib and pirfenidone modulate the effect of IPF fibroblast-conditioned matrix on normal fibroblast phenotype. Respirology. 2018 Aug;23(8):756-763. doi: 10.1111/resp.13287. Epub 2018 Mar 12.

  PMID: 29532550 RESULT

MeSH Terms

Conditions

Pneumonia

Interventions

pirfenidone

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Huilan Zhang, PD

CONTACT

15391532171; huilanz_76@163.com

Jianping Zhao, PD

CONTACT

13507138234; Zhaojp88@126.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of department of respiratory and critical care medicine, tongji hospital

Model Details: 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.

Study Record Dates

• First Submitted: February 10, 2020
• First Posted: February 25, 2020
• Study Start: February 4, 2020
• Primary Completion: April 30, 2020
• Study Completion: June 1, 2020
• Last Updated: February 25, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)