Details

Autor(en) / Beteiligte

• Montejano, Rocío
• de la Calle-Prieto, Fernando
• Velasco, María
• Guijarro, Carlos
• Queiruga-Parada, Javier
• Jiménez-González, María
• González-Ruano, Patricia
• Martínez, Patricia
• Goikoetxea, Ane Josune
• Ibarrola, Marta
• Ciudad, Marianela
• Gutiérrez, Ángela
• Torralba, Miguel
• Díaz-Brasero, Ana
• Ryan, Pablo
• Marcelo, Cristina
• Díez, Cristina
• Ibarra, Sofía
• Merino, Esperanza
• Estrada, Vicente
• Marcos, Javier
• Novella, María
• Rivera, María A
• Ruiz-Muñoz, Manuel
• de Miguel, Marta
• Soler, Llanos
• Del Álamo, Mikel
• Moreno, Santiago
• Carcas, Antonio J
• Borobia, Alberto M
• Arribas, José R

Titel

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

Ist Teil von

• Clinical infectious diseases, 2023-02, Vol.76 (3), p.e116-e125

Ort / Verlag

United States

Erscheinungsjahr

2023

Quelle

Oxford Journals 2020 Medicine

Beschreibungen/Notizen

• 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. 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 <95% and at least 1 increased inflammatory biomarker received baricitinib plus dexamethasone or dexamethasone alone. The primary endpoint was 28-day mortality. Main secondary endpoint was 28-day disease progression or critical care unit admission or mortality. The trial was stopped before reaching planned sample size due to the decrease in the number of cases and a mortality rate substantially lower than expected. 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. 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. EudraCT: 2020-001156-18.