Efficacy and Safety of Nintedanib in the Treatment of Pulmonary Fibrosis in Patients With Moderate to Severe COVID -19

COVID-19 Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04338802
• Other study ID #: huilanz Zhang
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: April 2, 2020
• Est. completion date: August 1, 2020

Study information

• Verified date: April 2020
• Source: Tongji Hospital
• Contact: Huilan Zhang, PD
• Phone: 15391532171
• Email: Huilanz_76[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 96
• Est. completion date: August 1, 2020
• Est. primary completion date: May 4, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. 18-70 years old (including 18 and 70 years old), regardless of gender;

2. 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;

3. CT examination of patients with multiple fibrotic shadows in both lungs;

4. 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;

5. Signed informed consent.

Exclusion Criteria:

1. Previous history of chronic bronchitis, emphysema, interstitial lung disease or pulmonary heart disease;

2. 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;

3. People with active peptic ulcer;

4. Patients during pregnancy and lactation

5. Patients with mental illness or others who cannot cooperate effectively;

6. Researcher judges uncomfortable to participate in trial

Related Conditions & MeSH terms

• COVID-19
• Effect of Drugs
• Nintedanib
• Pulmonary Fibrosis
• Safety

Intervention

Drug:
• Nintedanib 150 MG
Nintedanib cloth sulfonate 150 mg, twice a day, about 12 hours apart. Continuous medication for 8 weeks.

Other:
• Placebo
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Huilan Zhang

References & Publications (4)

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. — View 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. — View 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. — View 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;6:5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in forced vital capacity (FVC)	Changes in forced vital capacity (FVC) after treatment compared to baseline.	8 weeks
Secondary	Changes in carbon monoxide dispersion (DLco%)	Changes incarbon monoxide dispersion (DLco%) after treatment compared to baseline.	8 weeks
Secondary	Changes in the six-minute walk test (6MWT)	Changes in the six-minute walk test (6MWT) after treatment compared to baseline.	8 weeks
Secondary	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	8 weeks