Tenofovir Disoproxil Fumarate/Emtricitabine and Baricitinib for Patients at High Risk of Severe Coronavirus Disease 2019: The PANCOVID Randomized Clinical Trial

Background This study was designed to evaluate if patients with high risk for severe coronavirus disease 2019 (COVID-19) would benefit from treatment with tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) followed by baricitinib in case of hypoxemia and systemic inflammation. Methods PANCOVID is...

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Detalles Bibliográficos
Autores: Montejano, R, de la Calle-Prieto, F, Velasco, M, Guijarro, C, Queiruga-Parada, J, Jimenez-Gonzalez, M, Gonzalez-Ruano, P, Martinez, P, Goikoetxea, AJ, Ibarrola, M, Ciudad, M, Gutierrez, A, Torralba, M, Diaz-Brasero, A, Ryan, P, Marcelo, C, Diez, C, Ibarra, S, Merino, E, Estrada, V, Marcos, J, Novella, M, Rivera, MA, Ruiz-Munoz, M, de Miguel, M, Soler, L, Del Alamo, M, Moreno, S, Carcas, AJ, Borobia, AM, Arribas, JR
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2023
País:España
Institución:Instituto de Investigación Biomédica y Sanitaria de Alicante (ISABIAL)
Repositorio:r-ISABIAL. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica y Sanitaria de Alicante
OAI Identifier:oai:isabial.fundanetsuite.com:p9156
Acceso en línea:https://isabial.portalinvestigacion.com/publicaciones9156
Access Level:acceso abierto
Palabra clave:COVID-19
tenofovir disoproxil fumarate
emtricitabine
baricitinib
Descripción
Sumario:Background This study was designed to evaluate if patients with high risk for severe coronavirus disease 2019 (COVID-19) would benefit from treatment with tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) followed by baricitinib in case of hypoxemia and systemic inflammation. Methods PANCOVID is an open-label, double-randomized, phase 3 pragmatic clinical trial including adults with symptomatic COVID-19 with >= 2 comorbidities or aged >= 60 years and was conducted between 10 October 2020 and 23 September 2021. In the first randomization, patients received TDF/FTC or no TDF/FTC. In the second randomization, patients with room air oxygen saturation Results Of the 355 included participants, 97% were hospitalized at baseline. Overall, 28-day mortality was 3.1%. The 28-day mortality relative risk (RR) for participants treated with TDF/FTC was 1.76 (95% confidence interval [CI], .52-5.91; P = .379); it was 0.42 (95% CI, .11-1.59; P = .201) for those treated with baricitinib. The 28-day RR for the main secondary combined endpoint for participants treated with TDF/FTC was 0.95 (95% CI, .66-1.40; P = .774); it was 0.90 (95% CI, .61-1.33; P = .687) for those treated with baricitinib. Conclusions Our results do not suggest a beneficial effect of TDF/FTC; nevertheless, they are compatible with the beneficial effect of baricitinib already established by other clinical trials. The PANCOVID clinical trial does not suggest a beneficial effect of tenofovir disoproxil fumarate/emtricitabine for mainly hospitalized patients at high risk of severe COVID-19. Our results are compatible with the beneficial effect of baricitinib already established by prior clinical trials.

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