Dipeptidyl peptidase-1 inhibition in patients hospitalised with COVID-19: a multicentre, double-blind, randomised, parallel-group, placebo-controlled trial
PhD Holly R Keir, PhD Merete B Long, MD, Y H Giam BSc, T Pembridge BSc, L Delgado BSc, M Band MSc Hani Abo-Leyah, Yan Hui Giam, PhD Thenmalar Vadiveloo, Thomas Pembridge, Rebecca C Hull, Lilia Delgado, Margaret Band, Fiona Mclaren-Neil, PhD, E Lahnsteiner MSc, A Gilmour BSc Simon Adamson, Eva Lahnsteiner, Amy Gilmour, MSc Chloe Hughes, Benjamin Jm New, PhD, D David Connell, R C Hull BSc Rebecca Dowey, Helena Turton, PhD Hollian Richardson, Diane Cassidy, Jamie Cooper, MD Jay Suntharalingam, Lavanya Diwakar, PhD Peter Russell, PhD Jonathan Underwood, Davinder Alexander Hicks, Davinder Ps Dosanjh, Beth Sage, Devesh Dhasmana, PhD Mark Spears, Aa Roger Thompson, Christopher Brightling, Andrew Smith, Manish Patel, Prof Jacob George, Prof Alison M Condliffe, Amelia Shoemark, Prof Graeme Maclennan, on behalf of the STOP-COVID19 James D Chalmers, on behalf of the STOP-COVID19 James D Chalmers, MD, Y H Giam BSc, T Pembridge BSc, L Delgado BSc, M Band MSc Hani Abo-Leyah, Benjamin Jm New, Christine Almaden-Boyle, PhD, D David Connell, Jennifer Taylor, Jodie Strachan, Heather Loftus, Lesley Young, Angela Strachan, Margaret Band, Fiona Mclaren-Neil, Kristina Pilvinyte, PhD, E Lahnsteiner MSc, A Gilmour BSc Simon Adamson, Eva Lahnsteiner, Petra Rauchhaus, Fiona Hogarth, Prof Jacob George, Tricia Burns, Elizabeth Coote, Marney Keiller, Manish Patel, Andrew Smith, Elizabeth Sage, Jamie Cooper, David Miller, Davinder Dosanjh, Benjamin Sutton, PhD Jonathan Underwood, Sharon Frayling, Matthew Haynes, Lauren Broad, Laura Jones, Karen Rahilly, Catherine Oliver, Terriann Evans, Andrea Balan, Rhys Davies, Donal Forde, Clemency Nye, Dr Haboubi, Zoe Hilton, Jennie Williams, Alison Mcqueen, PhD Mark Spears, Ian Edmond, Dario Salutous, Laura Mcgenily, Rhona Scott, Eilidh Henderson, Andrea Collins, Devesh Dhasmana, Patrick Liu, Ana Morrow, Mandy Couser, Fleur Davey, Davinder Alexander Hicks, Laura Wiffen, Lauren Fox, Mohamed Abdelrahim, Alexander Darbyshire, Elena Cowen, Megan Rowley, Benjamin Giles, Yingjia Yang, Tom Brown, Hitasha Rupani, Elizabeth Hawes, Debi Barnes, Fiona Brogan, Roneleeh Bungue-Tuble, Serena Howe, Charlotte Turner, Sonia Baryschpolec, Bev Longhurst, Maria Moon, Lynn Watkins, Michelle Baker-Moffat, Lisa Murray, Yasmin Harrington-Davies, Kate Burrows, Chrissie Minnis, Mary Wands, Adefunke Bamgboye, Charlotte Wong, Christopher Brightling, Sarah Diver, Richard Russell, Hamish Mcauley, Omer Elneima, Ahmed Yousuf, Paula Mccourt, Beverley Hargadon, Sarah Parker, Michelle Bourne, MD Jay Suntharalingam, Tom Hartley, Vidan Masan, Sharon Sturney, Rob Mackenzie, Clare Marchand, Rebecca Mason, Katie White, Alison Kirby, Manjula Meda, Lavanya Diwakar, PhD Peter Russell, Joanne Finn, Sophie Harris, Carol Muir, Gemma Cook, Nikki Staines, Chris Cook, Aa Roger Thompson, Prof Alison M Condliffe, Rebecca C Hull, R C Hull BSc Rebecca Dowey, Helena Turton, Paul Collini, Zoé Gabriel, Simon Hardman, Helen Newell, Janet Middle, Phillip Simpson, Hayley Colton, Joann Barker, Katie Birchall, Kate Harrington, Kay Housley, Rebecca Lenagh, Jayne Wilson, Joan Wesonga, Rachel Whitham, Sarah Bird, Yvonne Jackson, Angeline Mbuyisa, Samantha Anderson, Anna Wilson, Faith Kibutu, Sara Walker, Kay Cawthron, Irene Macharia, Lynne Smart, Anna Emery, Alice Howell, Elizabeth Hurditch, Amber Ford, Kim Turner, Lisa Watson, Helen Bowler, Tracy Jackson, Carol Jaques, Nichole Dyer, Shelley Ducker, Vicky Goodall, Emily Udale
The Lancet Respiratory Medicine, doi:10.1016/s2213-2600(22)00261-2
Background Neutrophil serine proteases are involved in the pathogenesis of COVID-19 and increased serine protease activity has been reported in severe and fatal infection. We investigated whether brensocatib, an inhibitor of dipeptidyl peptidase-1 (DPP-1; an enzyme responsible for the activation of neutrophil serine proteases), would improve outcomes in patients hospitalised with COVID-19.
Methods In a multicentre, double-blind, randomised, parallel-group, placebo-controlled trial, across 14 hospitals in the UK, patients aged 16 years and older who were hospitalised with COVID-19 and had at least one risk factor for severe disease were randomly assigned 1:1, within 96 h of hospital admission, to once-daily brensocatib 25 mg or placebo orally for 28 days. Patients were randomly assigned via a central web-based randomisation system (TruST). Randomisation was stratified by site and age (65 years or ≥65 years), and within each stratum, blocks were of random sizes of two, four, or six patients. Participants in both groups continued to receive other therapies required to manage their condition. Participants, study staff, and investigators were masked to the study assignment. The primary outcome was the 7-point WHO ordinal scale for clinical status at day 29 after random assignment. The intention-totreat population included all patients who were randomly assigned and met the enrolment criteria. The safety population included all participants who received at least one dose of study medication. This study was registered with the ISRCTN registry, ISRCTN30564012. Findings Between June 5, 2020, and Jan 25, 2021, 406 patients were randomly assigned to brensocatib or placebo; 192 (47•3%) to the brensocatib group and 214 (52•7%) to the placebo group. Two participants were excluded after being randomly assigned in the brensocatib group (214 patients included in the placebo group and 190 included in the brensocatib group in the intention-to-treat population). Primary outcome data was unavailable for six patients (three in the brensocatib group and three in the placebo group). Patients in the brensocatib group had worse clinical status at day 29 after being randomly assigned than those in the placebo group (adjusted odds ratio 0•72 [95% CI 0•57-0•92]). Prespecified subgroup analyses of the primary outcome supported the primary results. 185 participants reported at least one adverse event; 99 (46%) in the placebo group and 86 (45%) in the brensocatib group. The most common adverse events were gastrointestinal disorders and infections. One death in the placebo group was judged as possibly related to study drug. Interpretation Brensocatib treatment did not improve clinical status at day 29 in patients hospitalised with COVID-19.
Declaration of interests JDC reports grants and personal fees from AstraZeneca, Boehringer-Ingelheim, Chiesi, GSK, Gilead Sciences, Grifols, Insmed, Janssen, Novartis, and Zambon. CB reports grants from the UK National Institute for Health and Care Research Biomedical Research Centre during the conduct of the study; grants and personal fees from GSK, AstraZeneca, Chiesi, Boehringer-Ingelheim, Genentech, Roche, Sanofi, Regeneron, Merck, TEVA, Mologic, 4DPharma, and Novartis. AART reports grants and personal fees from British Heart Foundation and Actelion Pharmaceuticals. JU reports personal fees from Gilead Sciences and ViiV Healthcare and from Celltrion; and is supported by the UK Medical Research Council (MR/T023791/1). DPSD reports grants and personal fees from GSK, Vir Biotechnology, AstraZeneca, and Boehringer-Ingelheim. ASm has received non-financial support for clinical trial work from AstraZeneca, GSK, Chiesi, and Oncimmune; and has done consultancy work with AstraZeneca and GSK. MP reports non-financial support for clinical trial work from AstraZeneca, GSK, Chiesi, and Oncimmune and consultancy work with AstraZeneca and GSK. All other authors report no competing interests.
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