Short- and long-term effects of imatinib in patients hospitalised for COVID-19 infection: A randomised controlled trial

We report the short- and long-term results of the SOLIDARITY Finland on mortality and other patient-important outcomes in patients hospitalised for COVID-19. Between 08/2021 and 03/2023, we randomised 156 patients in 15 hospitals. In the imatinib group, 7.2% of patients had died at 30 days and 13.3% at 1 year and in the standard of care group 4.1% and 8.3% (adjusted HR at 30 days 1.09, 95% CI 0.23–5.07). In a meta-analysis of randomised trials of imatinib versus standard of care (n=732), allocation to imatinib was associated with a mortality risk ratio of 0.73 (95% CI 0.32–1.63). At 1-year, self-reported recovery occurred in 79.0% in imatinib and in 88.3% in standard of care (RR 0.91, 95% CI 0.78-1.06). Of the 21 potential long COVID symptoms, patients often reported moderate or major bother from fatigue (24%), sleeping problems (19%) and memory difficulties (17%). We found no convincing difference between imatinib and standard of care groups in quality of life or symptom outcomes. The evidence raises serious doubts regarding the benefit of imatinib in reducing mortality, improving recovery, and preventing potential long COVID symptoms when given to patients hospitalised for COVID-19. ### Competing Interest Statement H.R.K. is consultant for Pfizer and Roche and received lecture honoraria from Pfizer. T.M. is advisory board member for GSK and received lecture honoraria from Astra-Zeneca, Boehringer-Ingelheim, Chiesi, GSK, and Orion. All other authors declare no competing interests. ### Clinical Trial EudraCT: 2020-001784-88; [ClinicalTrials.gov][1]: [NCT05220280][2] ### Funding Statement The study was funded by the Research Council of Finland (335527), Finnish Medical Foundation, Foundation of the Finnish Anti-Tuberculosis Association, Helsinki University Hospital State Research Funding (TYH2022330; TYH2023236), Paulo Foundation, Paivikki and Sakari Sohlberg Foundation, Research Foundation of the Pulmonary Diseases, Sigrid Juselius Foundation, Tampere Tuberculosis Foundation and Tampere University Hospital State Research Funding (9AC085). The World Health Organization (WHO) provided the study drug (imatinib) donated by Novartis. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: The trial complied with all relevant ethical regulations and received approval by the Finnish Medicines Agency Fimea (33/2020), National Committee on Medical Research Ethics TUKIJA (56/2021) and ethics board of the Helsinki University Hospital HUS (1866/2021). Additionally, the trial received approval locally from each of the 15 participating hospitals. I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as [ClinicalTrials.gov][1]. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes The dataset generated during and analysed during the current study are not publicly available for data security. The corresponding author (K.A.O.T.) is the custodian of the long-term follow-up data and will provide access to de-identified and processed participant data for academic purposes within 2 months on request (kari.tikkinen{at}helsinki.fi) with the completion of a data access agreement. [1]: https://ClinicalTrials.gov [2]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT05220280&atom=%2Fmedrxiv%2Fearly%2F2024%2F02%2F06%2F2024.02.02.24302227.atom