Short- and long-term effects of imatinib in hospitalized COVID-19 patients: A randomized trial - 10/08/24

Doi : 10.1016/j.jinf.2024.106217

Alex L.E. Halme ^a , Sanna Laakkonen ^a , Jarno Rutanen ^b,^c , Olli P.O. Nevalainen ^a,^b,^d , Marjatta Sinisalo ^c , Saana Horstia ^a , Jussi M.J. Mustonen ^e , Negar Pourjamal ^a , Aija Vanhanen ^f ,
Solidarity Finland Investigators
Tero Ala-Kokko ^a, Maarit Gockel ^b, Susanna Haapanen ^c, Mia Haukipää ^d, Sanna Lehtonen ^e, Eeva-Maija Nieminen ^e, Joni Niskanen ^c, Jarmo Oksi ^f, Ulla Otava ^c, Taija Rutanen ^g, Petri Salmela ^c, Joni Savolainen ^g, Susanna Tuominen ^e, Henri Vartiainen ^h, Heli Ylä-Outinen ⁱ
^a Department of Intensive Care, Oulu University Hospital and University of Oulu, Oulu, Finland
^b Laakso Hospital, City of Helsinki, Helsinki, Finland
^c Department of Internal Medicine, Tampere University Hospital, Tampere, Finland
^d Department of Infectious and Pulmonary Diseases, Hyvinkää Hospital, Hyvinkää, Finland
^e Department of Pulmonary Medicine, Heart and Lung Center, Helsinki University Hospital, Helsinki, Finland
^f Department of Infectious Diseases, University of Turku and Turku University Hospital, Turku, Finland
^g Suomen COVID-yhdistys ry, Finland
^h Department of Internal Medicine, Päijät-Häme Central Hospital, Lahti, Finland
ⁱ Department of Pulmonary Diseases and Allergology, Division of Medicine, University of Turku and Turku University Hospital, Turku, Finland

Tuomas Rosberg ^g , Andreas Renner ^h,^i,^j , Markus Perola ^k,^l , Erja-Leena Paukkeri ^c , Riitta-Liisa Patovirta ^m , Seppo Parkkila ⁿ , Juuso Paajanen ^h,ⁱ , Taina Nykänen ^o , Jarkko Mäntylä ^h , Marjukka Myllärniemi ^h,ⁱ , Tiina Mattila ^h , Maarit K. Leinonen ^p , Alvar Külmäsu ^q , Pauliina Kuutti ^a , Ilari Kuitunen ^r,^s , Hanna-Riikka Kreivi ^h , Tuomas P. Kilpeläinen ^t , Heikki Kauma ^u , Ilkka E.J. Kalliala ^v,^w , Petrus Järvinen ^t , Riina Hankkio ^x , Taina Hammarén ^f , Thijs Feuth ^y , Hanna Ansakorpi ^z , Riikka Ala-Karvia ^aa , Gordon H. Guyatt ^ab,^ac , Kari A.O. Tikkinen ^a,^t,^ab,^ad,^⁎
^a Faculty of Medicine, University of Helsinki, Helsinki, Finland
^b Faculty of Social Sciences, Tampere University, Tampere, Finland
^c Department of Internal Medicine, Tampere University Hospital, Tampere, Finland
^d Hatanpää Health Center, Wellbeing Services County of Pirkanmaa, Tampere, Finland
^e Mehiläinen Oy, Helsinki, Finland
^f Laakso Hospital, City of Helsinki, Helsinki, Finland
^g Department of Pulmonology, Kanta-Häme Central Hospital, Hämeenlinna, Finland
^h Department of Pulmonary Medicine, Heart and Lung Center, Helsinki University Hospital, Helsinki, Finland
ⁱ Individualized Drug Therapy Research Program, Faculty of Medicine, University of Helsinki, Helsinki, Finland
^j Department of Pneumology, University Hospital Vienna, Medical University of Vienna, Vienna, Austria
^k Department of Public Health and Welfare, Population Health Unit, Public Health Research Team, Finnish Institute for Health and Welfare, Helsinki, Finland
^l Clinical and Molecular Metabolism Research Program, Faculty of Medicine, University of Helsinki, Helsinki, Finland
^m Department of Medicine, Kuopio University Hospital, Kuopio, Finland
ⁿ Faculty of Medicine and Health Technology, Tampere University and Fimlab Ltd., Tampere University Hospital, Tampere, Finland
^o Department of Surgery, Hyvinkää Hospital, Hyvinkää, Finland
^p Teratology Information Service, Emergency Medicine and Services, University of Helsinki and Helsinki University Hospital, Helsinki, Finland
^q Department of Emergency Medicine, Päijät-Häme Central Hospital, Lahti, Finland
^r Department of Pediatrics, Mikkeli Central Hospital, Mikkeli, Finland
^s Institute of Clinical Medicine and Department of Pediatrics, University of Eastern Finland, Kuopio, Finland
^t Department of Urology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland
^u Department of Internal Medicine, Oulu University Hospital, Oulu, Finland
^v Department of Obstetrics and Gynaecology, Helsinki University and Helsinki University Hospital, Helsinki, Finland
^w Department of Metabolism, Digestion and Reproduction, Faculty of Medicine, Imperial College London, London, UK
^x Tampere University Hospital Pharmacy, Tampere University Hospital, Tampere, Finland
^y Department of Pulmonary Diseases and Allergology, Division of Medicine, University of Turku and Turku University Hospital, Turku, Finland
^z Research Unit of Clinical Neuroscience, Neurology, University of Oulu, Oulu, Finland
^aa Department of Internal Medicine, Seinäjoki Central Hospital, Seinäjoki, Finland
^ab Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, Ontario, Canada
^ac Department of Medicine, McMaster University, Hamilton, Ontario, Canada
^ad Department of Surgery, South Karelian Central Hospital, Lappeenranta, Finland

^⁎Correspondence to: Faculty of Medicine, University of Helsinki, Biomedicum 2 B, P.O. Box 13, Tukholmankatu 8 B, 00290 Helsinki, Finland.Faculty of Medicine, University of HelsinkiBiomedicum 2 B, P.O. Box 13, Tukholmankatu 8 BHelsinki00290Finland

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Summary

Objectives

We studied the short- and long-term effects of imatinib in hospitalized COVID-19 patients.

Methods

Participants were randomized to receive standard of care (SoC) or SoC with imatinib. Imatinib dosage was 400 mg daily until discharge (max 14 days). Primary outcomes were mortality at 30 days and 1 year. Secondary outcomes included recovery, quality of life and long COVID symptoms at 1 year. We also performed a systematic review and meta-analysis of randomized trials studying imatinib for 30-day mortality in hospitalized COVID-19 patients.

Results

We randomized 156 patients (73 in SoC and 83 in imatinib). Among patients on imatinib, 7.2% had died at 30 days and 13.3% at 1 year, and in SoC, 4.1% and 8.2% (adjusted HR 1.35, 95% CI 0.47–3.90). At 1 year, self-reported recovery occurred in 79.0% in imatinib and in 88.5% in SoC (RR 0.91, 0.78–1.06). We found no convincing difference in quality of life or symptoms. Fatigue (24%) and sleep issues (20%) frequently bothered patients at one year. In the meta-analysis, imatinib was associated with a mortality risk ratio of 0.73 (0.32–1.63; low certainty evidence).

Conclusions

The evidence raises doubts regarding benefit of imatinib in reducing mortality, improving recovery and preventing long COVID symptoms in hospitalized COVID-19 patients.

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Highlights

•	We found no short or long-term benefit from imatinib in hospitalized COVID-19.
•	Pooled evidence raises doubts regarding benefit of imatinib in reducing mortality.
•	Fatigue and sleeping problems common at 1 year after hospitalized COVID-19.

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Keywords : Clinical Trials, COVID-19, Immunomodulatory effects, Imatinib, Long COVID patient outcomes, Post-acute COVID syndrome, Post-COVID, Randomized controlled trial, SARS-CoV-2 infection, Tyrosine kinase inhibitors

Plan

Introduction

Methods

Study design and participants

Randomization and masking

Procedures and outcomes

Statistical analysis

Systematic review and meta-analysis

Results

Hospital outcomes and 30-day mortality (short-term follow-up)

Long-term follow-up

Systematic review and meta-analysis

Discussion

Funding

Author contributions

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Vol 89 - N° 3

Article 106217- septembre 2024 Retour au numéro

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Short- and long-term effects of imatinib in hospitalized COVID-19 patients: A randomized trial - 10/08/24

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