- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04282902
A Study to Evaluate the Efficacy and Safety of Pirfenidone With Novel Coronavirus Infection
A Randomized, Open-label Study to Evaluate the Efficacy and Safety of Pirfenidone in Patients With Severe and Critical Novel Coronavirus Infection
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study is a multi-center, randomized, open, blank-controlled, multi-stage clinical study. As there are no effective treatments, the project team will evaluate possible treatments (including but not limited to Pirfenidone) based on actual conditions. Ketone, Pirfenidone, lopinavir / ritonavir, remdesivir, single / polyclonal antibodies against coronavirus), explore the most effective treatment options.
The first phase will assess the efficacy and safety of approximately 147 (primarily estimated) hospitalized adult patients diagnosed with Wuhan new coronavirus infection in the pirfenidone-treated group compared to standard treatment.
Patients with influenza within 14 days of onset of symptoms were screened and randomly assigned as soon as possible after screening (within 4 day). Patients will be allocated in a 1: 1 ratio and divided into the pirfenidone treatment group or the standard treatment group only. Patients who do not meet the inclusion and exclusion criteria are only allowed to be re-screened once, provided that the time from onset of symptoms to randomization remains within 14days.
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 selection 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.
Study exclusion criteria: (1) AST and ALT> 1.5 x ULN at visit 1; (2) bilirubin> 1.5 x ULN at visit 1; (3) Cockcroft-Gault formula at visit 1 Calculated creatinine clearance rate <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; Screening visit (Visit 1) 1 month or 6 half-life (whichever is greater) received other research drug treatment; (7) Based on ATS / ERS / JRS / ALAT 2011 guidelines (P11-07084) IPF diagnosis; (8) Obvious pulmonary hypertension (PAH) defined by any of the following standards: ① Clinical / echocardiographic evidence of previously obvious right heart failure; ② Medical history including right heart catheter showing a heart index ≤ 2l / min / m2; ③ required Parenteral administration of epoprostenol / treprostinil for the treatment of PAH; (9) other clinically significant pulmonary abnormalities considered by the investigator; (10) major extrapulmonary physiological limitations (such as chest wall deformities, large amounts Pleural effusion); (11) cardiovascular disease, any of the following diseases: ① severe hypertension within 6 months of visit 1, treatment Uncontrollable (≥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 allergies to the test drug; (14) Other diseases that may interfere with the testing process or judged by the investigator may interfere with the trial participation or may put the patient at risk when participating in the trial; (15) pregnancy, Women who are breastfeeding or planning a pregnancy; (16) Patients are unable to understand or follow the test procedures, including completing the questionnaires themselves without help.
Study design primary and secondary endpoints Main endpoints: (1) Absolute changes in baseline lesion area, finger pulse oxygen, and blood gas from baseline at 4 weeks of chest CT images; (2) Total score of King's Interstitial Lung Disease Short Questionnaire (K-BILD) at Week 4 Absolute change from baseline.
Secondary end point: Time to death within 4 weeks due to respiratory causes; time to disease progression or death within 4 weeks; recovery of blood routine lymphocytes at week 4; and blood inflammation indicators at week 4 ( IL-8, etc.); at week 4, absolute changes in viral nucleic acid from baseline; at week 4, pulmonary fibrosis survival symptoms dyspnea scores absolute changes from baseline; at week 4, pulmonary fibrosis survival Symptoms of cough scores are absolute changes from baseline.
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Huilan Zhang, PD
- Phone Number: 15391532171
- Email: Huilanz_76@163.com
Study Contact Backup
- Name: Jianping Zhao, PD
- Phone Number: 13507138234
- Email: Zhaojp88@126.com
Study Locations
-
-
Hubei
-
Wuhan, Hubei, China
- Recruiting
- Tongji Hospital affiliated to Huazhong University of Science and Technology
-
Contact:
- Huilan Zhang, PD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
chest CT
Time Frame: 4 weeks
|
Lesion area of chest CT image at 4 weeks
|
4 weeks
|
Finger pulse oxygen
Time Frame: 4 weeks
|
Absolute change in pulse oxygen from baseline
|
4 weeks
|
blood gas
Time Frame: 4 weeks
|
Absolute change in blood gas from baseline
|
4 weeks
|
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
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
death
Time Frame: 4 weeks
|
Time to death within 4 weeks due to respiratory problems
|
4 weeks
|
Time to disease progression or death within 4 weeks
Time Frame: 4 weeks
|
Time to disease progression or death within 4 weeks
|
4 weeks
|
blood
Time Frame: 4 weeks
|
lymphocyte count
|
4 weeks
|
viral nucleic acid
Time Frame: 4 weeks
|
Absolute change in viral nucleic acid from baseline
|
4 weeks
|
dyspnea score
Time Frame: 4 weeks
|
Pulmonary fibrosis survival symptoms absolute changes in dyspnea score from baseline
|
4 weeks
|
blood
Time Frame: 4 weeks
|
changes in blood inflammatory indexes
|
4 weeks
|
cough scores
Time Frame: 4 weeks
|
Absolute change in cough scores for pulmonary fibrosis survival symptoms from baseline
|
4 weeks
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Lung Diseases
- Coronavirus Infections
- Pneumonia
- Physiological Effects of Drugs
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Antineoplastic Agents
- Pirfenidone
Other Study ID Numbers
- huilanz_76
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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