Back to resultsEfficacy and Safety of Nintedanib in the Treatment of Pulmonary Fibrosis in Patients With Moderate to Severe COVID -19
Primary Purpose
COVID-19, Nintedanib, Safety
Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Nintedanib 150 MG
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19
Eligibility Criteria
Inclusion Criteria:
- 18-70 years old (including 18 and 70 years old), regardless of gender;
- Infection with new coronavirus pneumonia was confirmed by throat swab nucleic acid test. Patients with severe and critical illness were clinically judged. The symptoms of acute infection have been alleviated after treatment (at least 14 days after onset, no fever for more than 3 days), and the disease is recovering Within three months;
- CT examination of patients with multiple fibrotic shadows in both lungs;
- Blood routine, liver, and kidney functions are within the controllable range: such as the normal upper limit of plasma total bilirubin and creatinine ≤ 1.5 times; AST, ALT, LDH ≤ 2 times the normal upper limit; sufficient hematopoietic function: such as white blood cells ≥4.0 × 109 / L, platelets ≥100 × 109 / L;
- Signed informed consent.
Exclusion Criteria:
- Previous history of chronic bronchitis, emphysema, interstitial lung disease or pulmonary heart disease;
- Combining with other serious diseases: such as those who have suffered myocardial infarction and uncontrollable diabetes within 6 months, and are considered unsuitable to participate in the trial;
- People with active peptic ulcer;
- Patients during pregnancy and lactation
- Patients with mental illness or others who cannot cooperate effectively;
- Researcher judges uncomfortable to participate in trial
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo group
Nintedanib group
Arm Description
Empty capsules with the same appearance and ingredients as Nintedanib soft capsules: one capsule at a time, twice a day, with an interval of about 12 hours each time. Continuous medication for 8 weeks.
Nintedanib cloth sulfonate soft capsule treatment: According to the drug manual recommendation, give Nintedanib cloth sulfonate soft capsule 150mg twice daily with an interval of about 12 hours each time. Continuous medication for 8 weeks.
Outcomes
Primary Outcome Measures
Changes in forced vital capacity (FVC)
Changes in forced vital capacity (FVC) after treatment compared to baseline.
Secondary Outcome Measures
Changes in carbon monoxide dispersion (DLco%)
Changes incarbon monoxide dispersion (DLco%) after treatment compared to baseline.
Changes in the six-minute walk test (6MWT)
Changes in the six-minute walk test (6MWT) after treatment compared to baseline.
Changes in High resolution CT score
Changes in High resolution CT score after treatment compared to baseline.The minimum and maximum values are 0 and 25 , and higher scores mean a worse outcome. As for the score, it is the expected value and will be determined according to the actual result
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04338802
Brief Title
Efficacy and Safety of Nintedanib in the Treatment of Pulmonary Fibrosis in Patients With Moderate to Severe COVID -19
Official Title
Efficacy and Safety of Nintedanib Ethanesulfonate Soft Capsule in the Treatment of Pulmonary Fibrosis in Patients With Moderate to Severe COVID-9(COVID 19) : a Single-center, Randomized, Placebo-controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 2, 2020 (Anticipated)
Primary Completion Date
May 4, 2020 (Anticipated)
Study Completion Date
August 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Huilan Zhang
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This center intends to conduct a single-center, randomized, placebo-controlled study to evaluate the effectiveness and safety of Nintedanib ethanesulfonate soft capsule in the treatment of pulmonary fibrosis in patients with moderate to severe COVID-19.
Detailed Description
This center intends to conduct a single-center, randomized, placebo-controlled study to evaluate the effectiveness and safety of Nintedanib ethanesulfonate soft capsule in the treatment of pulmonary fibrosis in patients with moderate to severe COVID-19. The number of cases is estimated based on the following:
This exploratory trial is expected to complete 80 case studies (randomly divided into control group and test group each with 40 cases), and the expected drop-out rate is not more than 20%, so the total number of cases is 96. Placebo control group:
Empty capsules with the same appearance and ingredients as Nintedanib soft capsules: one capsule at a time, twice a day, with an interval of about 12 hours each time. Continuous medication for 8 weeks.
Nintedanib Nintedanib cloth sulfonate soft capsule treatment: According to the drug manual recommendation, give Nintedanib cloth sulfonate soft capsule 150mg twice daily with an interval of about 12 hours each time, with food. Continuous medication for 8 weeks.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19, Nintedanib, Safety, Effect of Drugs
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
96 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
Empty capsules with the same appearance and ingredients as Nintedanib soft capsules: one capsule at a time, twice a day, with an interval of about 12 hours each time. Continuous medication for 8 weeks.
Arm Title
Nintedanib group
Arm Type
Experimental
Arm Description
Nintedanib cloth sulfonate soft capsule treatment: According to the drug manual recommendation, give Nintedanib cloth sulfonate soft capsule 150mg twice daily with an interval of about 12 hours each time. Continuous medication for 8 weeks.
Intervention Type
Drug
Intervention Name(s)
Nintedanib 150 MG
Intervention Description
Nintedanib cloth sulfonate 150 mg, twice a day, about 12 hours apart. Continuous medication for 8 weeks.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Empty capsules with the same appearance and ingredients as Nidanib soft capsules: one capsule at a time, twice a day, with an interval of about 12 hours each time. Continuous medication for 8 weeks.
Primary Outcome Measure Information:
Title
Changes in forced vital capacity (FVC)
Description
Changes in forced vital capacity (FVC) after treatment compared to baseline.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Changes in carbon monoxide dispersion (DLco%)
Description
Changes incarbon monoxide dispersion (DLco%) after treatment compared to baseline.
Time Frame
8 weeks
Title
Changes in the six-minute walk test (6MWT)
Description
Changes in the six-minute walk test (6MWT) after treatment compared to baseline.
Time Frame
8 weeks
Title
Changes in High resolution CT score
Description
Changes in High resolution CT score after treatment compared to baseline.The minimum and maximum values are 0 and 25 , and higher scores mean a worse outcome. As for the score, it is the expected value and will be determined according to the actual result
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18-70 years old (including 18 and 70 years old), regardless of gender;
Infection with new coronavirus pneumonia was confirmed by throat swab nucleic acid test. Patients with severe and critical illness were clinically judged. The symptoms of acute infection have been alleviated after treatment (at least 14 days after onset, no fever for more than 3 days), and the disease is recovering Within three months;
CT examination of patients with multiple fibrotic shadows in both lungs;
Blood routine, liver, and kidney functions are within the controllable range: such as the normal upper limit of plasma total bilirubin and creatinine ≤ 1.5 times; AST, ALT, LDH ≤ 2 times the normal upper limit; sufficient hematopoietic function: such as white blood cells ≥4.0 × 109 / L, platelets ≥100 × 109 / L;
Signed informed consent.
Exclusion Criteria:
Previous history of chronic bronchitis, emphysema, interstitial lung disease or pulmonary heart disease;
Combining with other serious diseases: such as those who have suffered myocardial infarction and uncontrollable diabetes within 6 months, and are considered unsuitable to participate in the trial;
People with active peptic ulcer;
Patients during pregnancy and lactation
Patients with mental illness or others who cannot cooperate effectively;
Researcher judges uncomfortable to participate in trial
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Huilan Zhang, PD
Phone
15391532171
Email
Huilanz_76@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Xianglin Yuan, PD
Phone
13667241722
Email
yuanxianglin@hust.edu.cn
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31566307
Citation
Flaherty KR, Wells AU, Cottin V, Devaraj A, Walsh SLF, Inoue Y, Richeldi L, Kolb M, Tetzlaff K, Stowasser S, Coeck C, Clerisme-Beaty E, Rosenstock B, Quaresma M, Haeufel T, Goeldner RG, Schlenker-Herceg R, Brown KK; INBUILD Trial Investigators. Nintedanib in Progressive Fibrosing Interstitial Lung Diseases. N Engl J Med. 2019 Oct 31;381(18):1718-1727. doi: 10.1056/NEJMoa1908681. Epub 2019 Sep 29.
Results Reference
background
PubMed Identifier
24836310
Citation
Richeldi L, du Bois RM, Raghu G, Azuma A, Brown KK, Costabel U, Cottin V, Flaherty KR, Hansell DM, Inoue Y, Kim DS, Kolb M, Nicholson AG, Noble PW, Selman M, Taniguchi H, Brun M, Le Maulf F, Girard M, Stowasser S, Schlenker-Herceg R, Disse B, Collard HR; INPULSIS Trial Investigators. Efficacy and safety of nintedanib in idiopathic pulmonary fibrosis. N Engl J Med. 2014 May 29;370(22):2071-82. doi: 10.1056/NEJMoa1402584. Epub 2014 May 18. Erratum In: N Engl J Med. 2015 Aug 20;373(8):782.
Results Reference
background
PubMed Identifier
32007143
Citation
Chen N, Zhou M, Dong X, Qu J, Gong F, Han Y, Qiu Y, Wang J, Liu Y, Wei Y, Xia J, Yu T, Zhang X, Zhang L. Epidemiological and clinical characteristics of 99 cases of 2019 novel coronavirus pneumonia in Wuhan, China: a descriptive study. Lancet. 2020 Feb 15;395(10223):507-513. doi: 10.1016/S0140-6736(20)30211-7. Epub 2020 Jan 30.
Results Reference
background
PubMed Identifier
15638943
Citation
Xie L, Liu Y, Fan B, Xiao Y, Tian Q, Chen L, Zhao H, Chen W. Dynamic changes of serum SARS-coronavirus IgG, pulmonary function and radiography in patients recovering from SARS after hospital discharge. Respir Res. 2005 Jan 8;6(1):5. doi: 10.1186/1465-9921-6-5.
Results Reference
background
Learn more about this trial
Efficacy and Safety of Nintedanib in the Treatment of Pulmonary Fibrosis in Patients With Moderate to Severe COVID -19
We'll reach out to this number within 24 hrs