Academic Journal
Imatinib in patients with severe COVID-19: a randomised, double-blind, placebo-controlled, clinical trial
| العنوان: | Imatinib in patients with severe COVID-19: a randomised, double-blind, placebo-controlled, clinical trial |
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| المؤلفون: | Aman, J., Duijvelaar, E., Botros, L., Kianzad, A., Schippers, J.R., Smeele, P.J., Azhang, S., Bartelink, I.H., Bayoumy, A.A., Bet, P.M., Boersma, W., Bonta, P.I., Boomars, K.A., Bos, L.D., Bragt, J. van, Braunstahl, G.J., Celant, L.R., Eger, K.A.B., Geelhoed, J.J.M., Glabbeek, Y.L.E. van, Grotjohan, H.P., Hagens, L.A., Happe, C.M., Hazes, B.D., Heunks, L.M., Heuvel, M.M. van den, Hoefsloot, W., Hoek, R.J.A., Hoekstra, R., Hofstee, H.M.A., Juffermans, N.P., Kemper, E.M., Kos, R., Kunst, P.W., Lammers, A., Lee, I. van der, Lee, E.L. van der, Maitland-van der Zee, A.H., Asam, P.F.M. Mau, Mieras, A., Muller, Mirte, Neefjes, E.C.W., Nossent, E.J., Oswald, L.M.A., Overbeek, M.J., Pamplona, C.C., Paternotte, N., Pronk, N., Raaf, M.A. de, Raaij, B.F.M. van, Reijrink, M., Schultz, M.J., Neto, A. Serpa, Slob, E.M.A., Smeenk, F., Smit, M.R., Smits, A.J., Stalenhoef, J.E., Tuinman, P.R., Vanhove, A., Wessels, J.N., Wezenbeek, J.C.C. van, Noordegraaf, A. Vonk, Man, F.S. de, Bogaard, H.J. |
| المصدر: | Lancet Respiratory Medicine, 9, 9, pp. 957-968 |
| سنة النشر: | 2021 |
| المجموعة: | Radboud University: DSpace |
| مصطلحات موضوعية: | Radboudumc 4: lnfectious Diseases and Global Health RIHS: Radboud Institute for Health Sciences, Radboudumc 9: Rare cancers RIMLS: Radboud Institute for Molecular Life Sciences |
| الوصف: | Contains fulltext : 242606.pdf (Publisher’s version ) (Closed access) ; BACKGROUND: The major complication of COVID-19 is hypoxaemic respiratory failure from capillary leak and alveolar oedema. Experimental and early clinical data suggest that the tyrosine-kinase inhibitor imatinib reverses pulmonary capillary leak. METHODS: This randomised, double-blind, placebo-controlled, clinical trial was done at 13 academic and non-academic teaching hospitals in the Netherlands. Hospitalised patients (aged ≥18 years) with COVID-19, as confirmed by an RT-PCR test for SARS-CoV-2, requiring supplemental oxygen to maintain a peripheral oxygen saturation of greater than 94% were eligible. Patients were excluded if they had severe pre-existing pulmonary disease, had pre-existing heart failure, had undergone active treatment of a haematological or non-haematological malignancy in the previous 12 months, had cytopenia, or were receiving concomitant treatment with medication known to strongly interact with imatinib. Patients were randomly assigned (1:1) to receive either oral imatinib, given as a loading dose of 800 mg on day 0 followed by 400 mg daily on days 1-9, or placebo. Randomisation was done with a computer-based clinical data management platform with variable block sizes (containing two, four, or six patients), stratified by study site. The primary outcome was time to discontinuation of mechanical ventilation and supplemental oxygen for more than 48 consecutive hours, while being alive during a 28-day period. Secondary outcomes included safety, mortality at 28 days, and the need for invasive mechanical ventilation. All efficacy and safety analyses were done in all randomised patients who had received at least one dose of study medication (modified intention-to-treat population). This study is registered with the EU Clinical Trials Register (EudraCT 2020-001236-10). FINDINGS: Between March 31, 2020, and Jan 4, 2021, 805 patients were screened, of whom 400 were eligible and randomly assigned to the imatinib group (n=204) or ... |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | unknown |
| Relation: | https://repository.ubn.ru.nl/handle/2066/242606; http://dx.doi.org/10.1016/S2213-2600(21)00237-X |
| DOI: | 10.1016/S2213-2600(21)00237-X |
| الاتاحة: | https://repository.ubn.ru.nl/handle/2066/242606 https://doi.org/10.1016/S2213-2600(21)00237-X |
| رقم الانضمام: | edsbas.1AA4B40E |
| قاعدة البيانات: | BASE |
| DOI: | 10.1016/S2213-2600(21)00237-X |
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