TD-0903 for acute lung injury associated with COVID-19 [COVID-19]
Research type
Research Study
Full title
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-group, Multi-center Study of an Inhaled Pan-Janus Kinase Inhibitor, TD-0903, to Treat Symptomatic Acute Lung Injury Associated with COVID-19
IRAS ID
282925
Contact name
Dave Singh
Contact email
Sponsor organisation
Theravance Biopharma Ireland Limited
Eudract number
2020-001807-18
Duration of Study in the UK
0 years, 4 months, 16 days
Research summary
Summary of Research
The main purpose of this study is to compare the efficacy and safety of TD-0903, an inhaled pan-JAK inhibitor, with placebo over 7 days in subjects with confirmed COVID-19 hospitalised for symptomatic respiratory insufficiency. This study will also evaluate the PK of TD-0903 in these subjects.
Summary of Results
This Phase 2 study aimed to determine if hospitalized subjects requiring oxygen support due to severe COVID-19 could derive greater benefit from inhaled nezulcitinib in addition to standard of care relative to placebo plus standard of care.
The inhaled lung-selective pan-Janus Kinase inhibitor nezulcitinib appears generally well tolerated in hospitalised patients with severe COVID-19, with trends for improved ventilator-free survival and fewer deaths versus placebo. In two key subpopulations of COVID-19 subjects in the study, those with a baseline C-reactive protein of less than 150 mg/L, and those with a clinical status of 5 on the 8-point NIAID ordinal scale, nezulcitinib at a dose of 3 mg once daily for up to 7 days (with a 6-mg loading dose on Day 1) showed a nominally statistically significant improvement in the clinically important endpoints of 28-day all-cause mortality rate, time to mortality, and ventilator-free survival compared to placebo. Nezulcitinib 1-, 3-, and 10 mg showed a favourable safety profile with similar or numerically less frequent adverse events and serious adverse events relative to placebo.
Nezulcitinib may confer clinical benefit in hospitalised patients with COVID-19; further studies are required for validation.REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
20/NW/0245
Date of REC Opinion
18 May 2020
REC opinion
Further Information Favourable Opinion