Tenofovir Disoproxil Fumarate/Emtricitabine and Baricitinib for Patients at High Risk of Severe Coronavirus Disease 2019: The PANCOVID Randomized Clinical Trial
Por:
Montejano, R, de la Calle-Prieto, F, Velasco, M, Guijarro, C, Queiruga-Parada, J, Jimenez-Gonzalez, M, Gonzalez-Ruano, P, Martinez, P, Goikoetxea, A, 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, M, Ruiz-Munoz, M, de Miguel, M, Soler, L, Del Alamo, M, Moreno, S, Carcas, A, Borobia, A and Arribas, J
Publicada:
8 feb 2023
Ahead of Print:
1 jul 2022
Resumen:
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.
Filiaciones:
Montejano, R:
La Paz Univ Hosp, Ctr Invest Biomed Red Enfermedades Infecciosas, Inst Invest Hosp Univ La Paz, Infect Dis Unit,Internal Med Dept, Madrid, Spain
de la Calle-Prieto, F:
La Paz Univ Hosp, Ctr Invest Biomed Red Enfermedades Infecciosas, Inst Invest Hosp Univ La Paz, Infect Dis Unit,Internal Med Dept, Madrid, Spain
Velasco, M:
Univ Hosp Fdn Alcorcon, Res Unit, Infect Dis, Madrid, Spain
Guijarro, C:
Rey Juan Carlos Univ, Univ Hosp Fdn Alcorcon, Internal Med Unit, Madrid, Spain
Queiruga-Parada, J:
La Paz Univ Hosp, Inst Invest Hosp Univ La Paz, Clin Pharmacol Dept, Infect Dis Unit, Madrid, Spain
Jimenez-Gonzalez, M:
La Paz Univ Hosp, Spanish Clin Res Network, Inst Invest Hosp Univ La Paz, Clin Pharmacol Dept, Madrid, Spain
Gonzalez-Ruano, P:
Univ Hosp Infanta Sofia, Internal Med Dept, Madrid, Spain
Martinez, P:
Univ Hosp Infanta Sofia, Internal Med Dept, Madrid, Spain
Goikoetxea, A:
Cruces Univ Hosp, Infect Dis Unit, Baracaldo, Spain
Ibarrola, M:
Cruces Univ Hosp, Infect Dis Unit, Baracaldo, Spain
Ciudad, M:
La Princesa Univ Hosp, Internal Med Dept, Infect Dis Unit, Madrid, Spain
Gutierrez, A:
La Princesa Univ Hosp, Internal Med Dept, Infect Dis Unit, Madrid, Spain
Torralba, M:
Univ Alcala, Guadalajara Univ Hosp, Internal Med Dept, Alcala De Henares, Spain
Diaz-Brasero, A:
Univ Alcala, Guadalajara Univ Hosp, Internal Med Dept, Alcala De Henares, Spain
Ryan, P:
Univ Complutense Madrid, Infanta Leonor Univ Hosp, Ctr Invest Biomed Red Enfermedades Infecciosas, Sch Med, Madrid, Spain
Marcelo, C:
Hosp Emergencias Enfermera Isabel Zendal, Madrid, Spain
Diez, C:
Gregorio Maranon Univ Hosp, Inst Invest Sanitaria Gregorio Maranon, Clin Microbiol & Infect Dis Dept, Madrid, Spain
Ibarra, S:
Basurto Univ Hosp, Infect Dis Dept, Basurto, Spain
:
Alicante Gen Univ Hosp, Alicante Inst Hlth & Biomed Res, Infect Dis Unit, Alicante, Spain
Estrada, V:
Clin San Carlos Univ Hosp, Hosp Clin San Carlos, Inst Invest Sanitaria, Internal Med Dept,Infect Dis Unit, Madrid, Spain
Marcos, J:
Univ Hosp Fdn Alcorcon, Internal Med Dept, Madrid, Spain
Novella, M:
Principe Asturias Univ Hosp, Internal Med, Alcala De Henares, Spain
Rivera, M:
La Paz Univ Hosp, Emergency Dept, Madrid, Spain
Ruiz-Munoz, M:
Univ Hosp Fdn Alcorcon, Internal Med Dept, Madrid, Spain
de Miguel, M:
Fdn SEIMC GeSIDA, Madrid, Spain
Soler, L:
Univ Hosp Infanta Sofia, Internal Med Dept, Madrid, Spain
Del Alamo, M:
Cruces Univ Hosp, Infect Dis Unit, Baracaldo, Spain
Moreno, S:
Univ Alcala, Ramon y Cajal Univ Hosp, Ctr Invest Biomed Red Enfermedades Infecciosas, Infect Dis Dept,Sch Med,Inst Ramon y Cajal Invest, Madrid, Spain
Carcas, A:
Autonomous Univ Madrid, La Paz Univ Hosp,Clin Pharmacol Dept, Ctr Invest Biomed Red Enfermedades Infecciosas,Sc, Spanish Clin Res Network,Inst Invest Hosp Univ La, Madrid, Spain
Borobia, A:
Autonomous Univ Madrid, La Paz Univ Hosp,Clin Pharmacol Dept, Ctr Invest Biomed Red Enfermedades Infecciosas,Sc, Spanish Clin Res Network,Inst Invest Hosp Univ La, Madrid, Spain
Arribas, J:
Autonomous Univ Madrid, La Paz Univ Hosp, Inst Invest Hosp Univ La Paz,Infect Dis Unit,Inte, Sch Med,Ctr Invest Biomed Red Enfermedades Infecc, Madrid, Spain
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