Pragmatic, open-label, single-center, randomized, phase II clinical trial to evaluate the efficacy and safety of methylprednisolone pulses and tacrolimus in patients with severe pneumonia secondary to COVID-19: The TACROVID trial protocol
| Autor: | R. Rigo-Bonnin, Olga Capdevila, Adriana Iriarte, L. Arregui, N. Calvo, J. Sabater, Cristian Tebé, Xavier Corbella, S. Bolivar, A. Mensa-Vilaró, P. Hereu, Marta Fanlo-Maresma, Sebastián Videla, A. Antoli, Jordi Niubó, J Bas, X. Solanich, F. Mitjavila, N. Padullés, M. Molina |
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| Jazyk: | angličtina |
| Rok vydání: | 2021 |
| Předmět: |
medicine.medical_specialty
Randomization Lung injury Single Center COVID-19 (Malaltia) Resposta immunitària -- Regulació Methylprednisolone Article Immune response -- Regulation Tacrolimus 03 medical and health sciences 0302 clinical medicine Internal medicine medicine Respuesta inmune -- Regulación 030212 general & internal medicine Pulmones -- Heridas y lesiones Lung Pharmacology Inflammation lcsh:R5-920 Infecciones Inflamación business.industry SARS-CoV-2 Pulmó COVID-19 General Medicine medicine.disease Lesió pulmonar Inflamació Clinical trial Pneumonia Infecció Cytokine storm business Infection lcsh:Medicine (General) 030217 neurology & neurosurgery medicine.drug |
| Zdroj: | Contemporary Clinical Trials Communications, Vol 21, Iss, Pp 100716-(2021) Dipòsit Digital de la UB Universidad de Barcelona Contemporary Clinical Trials Communications |
| ISSN: | 2451-8654 |
| Popis: | IntroductionSome COVID-19 patients evolve to severe lung injury and systemic hyperinflammatory syndrome triggered by both the coronavirus infection and the subsequent host-immune response. Accordingly, the use of immunomodulatory agents has been suggested but still remains controversial. Our working hypothesis is that methylprednisolone pulses and tacrolimus may be an effective and safety drug combination for treating severe COVID-19 patients.Methods and analysisTACROVID is a randomized, open-label, single-center, phase II trial to evaluate the efficacy and safety of methylprednisolone pulses and tacrolimus plus standard of care (SoC) versus SoC alone, in patients at advanced stage of COVID-19 disease with lung injury and systemic hyperinflammatory response. Patients are randomly assigned (1:1) to one of two arms (42 patients in each group). The primary aim is to assess the time to clinical stability after initiating randomization. Clinical stability is defined as body temperature ≤ 37.5°C, and PaO2/FiO2 > 400 and/or SatO2/FiO2 > 300, and respiratory rate ≤24 rpm; for 48 consecutive hours.DiscussionMethylprednisolone and tacrolimus might be beneficial to treat those COVID-19 patients progressing into severe pulmonary failure and systemic hyperinflammatory syndrome. The rationale for its use is the fast effect of methylprednisolone pulses and the ability of tacrolimus to inhibit both the CoV-2 replication and the secondary cytokine storm. Interestingly, both drugs are low-cost and can be manufactured on a large scale; thus, if effective and safe, a large number of patients could be treated in developed and developing countries.Trial registration numberNCT04341038 / EudraCT: 2020-001445-39 |
| Databáze: | OpenAIRE |
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