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Efficacy and safety of nintedanib on lung fibrosis in severe pneumonia induced by coronavirus disease 2019: Historical control study.

Efficacy of nintedanib on severe COVID-19 pneumonia.

30

We included 30 patients (23 Males and 7 Females) were admitted to the ICUs with the diagnosis of COVID-19 and underwent mechanical ventilation. Median age and body mass index was 75 years old and 24.6 kg/m3, respectively.

We started patient recruitment from July 29, 2020, and completed it at October 1, 2020 because the number of participant reached the preplanned number.

Mild, moderate and severe gastrointestinal adverse events were developed in 83.3%, 30.0% and 6.7% in the participants. These rates were not significantly different compared to the control group. Mild, moderate and severe cute liver failure were developed in 80%, 36.7% and 6.7% in the participants. These rates were not significantly different compared to the control group.

The 28 day mortality rate was 23.3% (7 of 30 patients) in the control group versus 20% (6 of 30 patients) in the nintedanib group. The difference between the 2 groups was not significant (P:0.834, log-rank test). However, the lengths of mechanical ventilation were significantly shorter in the nintedanib group (P:0.046, Gehan Breslow Wilcoxon test). Furthermore, the median number of ventilator-free days within 28 days was significantly longer in the nintedanib group (12 vs 17 days, P:0.038). Computed tomography volumetry showed that the percentages of high attenuation areas were significantly lower in the nintedanib group at liberation from mechanical ventilation (38.7% vs 25.7%, P:0.027).

Thirty patients were in nintedanib group and 30 patients were in control group. There were no significant differences in 28-day mortality between the groups. Lengths of mechanical ventilation were significantly shorter in the nintedanib group. Computed tomography volumetry showed that the percentages of high-attenuation areas were significantly lower in the nintedanib group.These finding suggested that the administration of nintedanib may offer potential benefits for minimizing lung injury in COVID-19.

Oct. 05, 2022

May. 25, 2021

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8146615/pdf/main.pdf

No

We do not plan to share IPD.

https://jrct.niph.go.jp/latest-detail/jRCTs051200036

Umemura Yutaka

Osaka Genaral Medical Center

3-1-56, Bandaihigashi, Sumiyoshiku, Osaka, Osaka

plum0022@yahoo.co.jp

Umemura Yutaka

Osaka

3-1-56, Bandaihigashi, Sumiyoshiku, Osaka, Osaka

+81-6-6692-1201

plum0022@yahoo.co.jp

Complete

July. 27, 2020

Interventional

single arm study

open(masking not used)

historical control

single assignment

treatment purpose

1) Obtaining sufficient informed consent for this trials from participates or their close relatives
2) 20 years or older at the time of informed consent
3) Confirmed COVID-19 by PCR assay or LAMP assay
4) Respiratory failure requiring mechanical ventilation
5) Availability of a nasogastric tube

1) History of Idiopathic pulmonary fibrosis
2) History of chronic liver failure (Child Pugh B or C)
3) Breastfeeding and pregnancy
4) History or proven risk factors of thrombosis
5) Proven risk factors of bleeding
6) Unavailable to use enteral tube
7) Ineligibility for other reasons

Both

Severe pneumonia induced by COVID-19

Administration of nintedanib via nasogastric tube

COVID-19

nintedanib

COVID-19

nintedanib

28 days mortality after the initiation of mechanical ventilation

1) Gastrointestinal adverse events within 28 days after adiministration of nintedanib
2) Liver failure within 28 days after adiministration of nintedanib
3) P/F ratio and KL-6, 14 days and 28 days after the initiation of mechanical ventilation

+81-6-6692-1201

July. 08, 2020

none