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
Author
Solanich, Xavier
Antolí, Arnau
Padullés, Núria
Fanlo-Maresma, Marta
Iriarte, Adriana
Mitjavila, Francesca
Capdevila, Olga
Molina, M.
Sabater-Riera, Joan
Bas, Jordi
Mensa-Vilaró, Anna
Niubó, Jordi
Calvo, Nahum
Bolivar, Santiago
Rigo-Bonnin, Raúl
Arregui, Laura
Tebé, Cristian
Hereu, Pilar
Videla, S.
Corbella Virós, Xavier
Publication date
2021-03ISSN
2451-8654
Abstract
Introduction: Some 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 analysis: TACROVID 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. Discussion: Methylprednisolone 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.
Document Type
Article
Document version
Published version
Language
English
Subject (CDU)
61 - Medical sciences
Keywords
COVID-19 (Malaltia)
Inflamació
Lesió pulmonar
Infecció
Resposta immunitària -- Regulació
COVID-19
Inflamación
Pulmones -- Heridas y lesiones
Infecciones
Respuesta inmune -- Regulación
COVID-19
Inflammation
Lung injury
Infection
Immune response -- Regulation
Pages
8
Publisher
Elsevier
Collection
21;
Is part of
Contemporary Clinical Trials Communications
Citation
Solanich, X.; Antolí, A.; Padullés, N. [et al.]. 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. Contemporary Clinical Trials Communications, 2021, 21, 100716. Disponible en: <https://www.sciencedirect.com/science/article/pii/S2451865421000181?via%3Dihub>. Fecha de acceso: 16 feb. 2021. DOI: 10.1016/j.conctc.2021.100716
This item appears in the following Collection(s)
- Ciències de la Salut [740]
Rights
© 2021 The Authors. Published by Elsevier Inc. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).
Except where otherwise noted, this item's license is described as http://creativecommons.org/licenses/by/4.0/