Efficacy of nintedanib on severe COVID-19 pneumonia.

JRCT ID: jRCTs051200036

Registered date:27/07/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Severe pneumonia induced by COVID-19
• Date of first enrollment: 29/07/2020
• Target sample size: 30
• Study type: Interventional
• Intervention(s): Administration of nintedanib via nasogastric tube

Outcome(s)

• Primary Outcome: 28 days mortality after the initiation of mechanical ventilation

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

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

Exclude criteria

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

Related Information

• Primary Sponsor: Umemura Yutaka
• Source(s) of Monetary Support: Osaka General Medical Center, Funding for research projects