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A randomized clinical trial of lipid metabolism modulation with fenofibrate for acute coronavirus disease 2019.
Chirinos, Julio A; Lopez-Jaramillo, Patricio; Giamarellos-Bourboulis, Evangelos J; Dávila-Del-Carpio, Gonzalo H; Bizri, Abdul Rahman; Andrade-Villanueva, Jaime F; Salman, Oday; Cure-Cure, Carlos; Rosado-Santander, Nelson R; Cornejo Giraldo, Mario P; González-Hernández, Luz A; Moghnieh, Rima; Angeliki, Rapti; Cruz Saldarriaga, María E; Pariona, Marcos; Medina, Carola; Dimitroulis, Ioannis; Vlachopoulos, Charalambos; Gutierrez, Corina; Rodriguez-Mori, Juan E; Gomez-Laiton, Edgar; Cotrina Pereyra, Rosa; Ravelo Hernández, Jorge Luis; Arbañil, Hugo; Accini-Mendoza, José; Pérez-Mayorga, Maritza; Milionis, Charalampos; Poulakou, Garyfallia; Sánchez, Gregorio; Valdivia-Vega, Renzo; Villavicencio-Carranza, Mirko; Ayala-García, Ricardo J; Castro-Callirgos, Carlos A; Alfaro Carrasco, Rosa M; Garrido Lecca Danos, Willy; Sharkoski, Tiffany; Greene, Katherine; Pourmussa, Bianca; Greczylo, Candy; Ortega-Legaspi, Juan; Jacoby, Douglas; Chittams, Jesse; Katsaounou, Paraskevi; Alexiou, Zoi; Sympardi, Styliani; Sweitzer, Nancy K; Putt, Mary; Cohen, Jordana B.
Affiliation
  • Chirinos JA; Division of Cardiovascular Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA. julio.chirinos@uphs.upenn.edu.
  • Lopez-Jaramillo P; Instituto de Investigación MASIRA, Facultad de Ciencias de la Salud, Universidad de Santander, Bucaramanga, Colombia.
  • Giamarellos-Bourboulis EJ; 4th Department of Internal Medicine, National and Kapodistrian University of Athens, Medical School and Hellenic Institute for the Study of Sepsis, Athens, Greece.
  • Dávila-Del-Carpio GH; Universidad Católica de Santa María, Arequipa, Peru.
  • Bizri AR; Department of Medicine, American University of Beirut, Beirut, Lebanon.
  • Andrade-Villanueva JF; Unidad de VIH, Hospital Civil de Guadalajara and Universidad de Guadalajara, Guadalajara, Mexico.
  • Salman O; 4th Department of Internal Medicine, National and Kapodistrian University of Athens, Medical School and Hellenic Institute for the Study of Sepsis, Athens, Greece.
  • Cure-Cure C; Department of Medicine, American University of Beirut, Beirut, Lebanon.
  • Rosado-Santander NR; BIOMELAB S.A.S., Barranquilla, Colombia.
  • Cornejo Giraldo MP; Department of Medicine, Hospital Nacional Carlos Alberto Seguín Escobedo, EsSalud, Arequipa, Peru.
  • González-Hernández LA; Hospital Carlos Alberto Seguín Escobedo, Arequipa, Peru.
  • Moghnieh R; Unidad de VIH, Hospital Civil de Guadalajara and Universidad de Guadalajara, Guadalajara, Mexico.
  • Angeliki R; Department of Medicine, Makassed General Hospital, Beirut, Lebanon.
  • Cruz Saldarriaga ME; 6th Department of Pulmonary Medicine, SOTIRIA Athens General Hospital of Chest Disease, Athens, Greece.
  • Pariona M; Centro de Investigación de Enfermedades Infecciosas y Tropicales, Hospital Nacional Adolfo Guevara Velasco, Cuzco, Peru.
  • Medina C; Hospital Nacional Edgardo Rebagliati Martins, EsSalud, Lima, Peru.
  • Dimitroulis I; Hospital Nacional Edgardo Rebagliati Martins, EsSalud, Lima, Peru.
  • Vlachopoulos C; 6th Department of Pulmonary Medicine, SOTIRIA Athens General Hospital of Chest Disease, Athens, Greece.
  • Gutierrez C; 1st Department of Cardiology, National and Kapodistrian University of Athens, Medical School,, Athens, Greece.
  • Rodriguez-Mori JE; BIOMELAB S.A.S., Barranquilla, Colombia.
  • Gomez-Laiton E; Department of Nephrology, Hospital Nacional Alberto Sabogal Sologuren, EsSalud, Lima, Peru.
  • Cotrina Pereyra R; FOSCAL Internacional Floridablanca, Santander, Colombia.
  • Ravelo Hernández JL; Hospital Nacional Guillermo Almenara Irigoyen, Lima, Peru.
  • Arbañil H; Hospital Central Fuerza Aérea del Peru, Miraflores, Peru.
  • Accini-Mendoza J; Hospital Nacional Dos de Mayo, Lima, Peru.
  • Pérez-Mayorga M; IPS Centro Científico Asistencial, Barranquilla, Colombia.
  • Milionis C; Clínica de Marly, Sede UNIMARLY, Bogota, Colombia.
  • Poulakou G; Department of Internal Medicine, Ioannina University General Hospital, Ioannina, Greece.
  • Sánchez G; 3rd Department of Internal Medicine, National and Kapodistrian University of Athens, Medical School, Athens, Greece.
  • Valdivia-Vega R; Fundación Cardiomet Cequin, Armenia, Colombia.
  • Villavicencio-Carranza M; Hospital Nacional Edgardo Rebagliati Martins, EsSalud, Lima, Peru.
  • Ayala-García RJ; Hospital Nacional Edgardo Rebagliati Martins, EsSalud, Lima, Peru.
  • Castro-Callirgos CA; Hospital Nacional Edgardo Rebagliati Martins, EsSalud, Lima, Peru.
  • Alfaro Carrasco RM; Department of Nephrology, Hospital Nacional Alberto Sabogal Sologuren, EsSalud, Lima, Peru.
  • Greene K; 4th Department of Internal Medicine, National and Kapodistrian University of Athens, Medical School and Hellenic Institute for the Study of Sepsis, Athens, Greece.
  • Pourmussa B; 4th Department of Internal Medicine, National and Kapodistrian University of Athens, Medical School and Hellenic Institute for the Study of Sepsis, Athens, Greece.
  • Greczylo C; 4th Department of Internal Medicine, National and Kapodistrian University of Athens, Medical School and Hellenic Institute for the Study of Sepsis, Athens, Greece.
  • Ortega-Legaspi J; 4th Department of Internal Medicine, National and Kapodistrian University of Athens, Medical School and Hellenic Institute for the Study of Sepsis, Athens, Greece.
  • Jacoby D; 4th Department of Internal Medicine, National and Kapodistrian University of Athens, Medical School and Hellenic Institute for the Study of Sepsis, Athens, Greece.
  • Chittams J; 4th Department of Internal Medicine, National and Kapodistrian University of Athens, Medical School and Hellenic Institute for the Study of Sepsis, Athens, Greece.
  • Katsaounou P; Biostatistics Analysis Core, Office of Nursing Research, University of Pennsylvania School of Nursing, Philadelphia, PA, USA.
  • Alexiou Z; Section of Pneumonology and Respiratory Failure, 1st Department of Critical Care Medicine, National and Kapodistrian University of Athens, Medical School, Athens, Greece.
  • Sympardi S; 2nd Department of Internal Medicine, THRIASIO Eleusis General Hospital, Eleusis, Greece.
  • Sweitzer NK; 1st Department of Internal Medicine, THRIASIO Eleusis General Hospital, Eleusis, Greece.
  • Putt M; Department of Medicine, Washington University School of Medicine, St. Louis, MO, USA.
  • Cohen JB; Division of Cardiology, University of Arizona, Tucson, AZ, USA.
Nat Metab ; 4(12): 1847-1857, 2022 12.
Article in En | MEDLINE | ID: mdl-36344766
ABSTRACT
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) cytotoxicity may involve inhibition of peroxisome proliferator-activated receptor alpha. Fenofibrate activates peroxisome proliferator-activated receptor alpha and inhibits SARS-CoV-2 replication in vitro. Whether fenofibrate can be used to treat coronavirus disease 2019 (COVID-19) infection in humans remains unknown. Here, we randomly assigned inpatients and outpatients with COVID-19 within 14 d of symptom onset to 145 mg of oral fenofibrate nanocrystal formulation versus placebo for 10 d, in a double-blinded fashion. The primary endpoint was a severity score whereby participants were ranked across hierarchical tiers incorporating time to death, mechanical ventilation duration, oxygenation, hospitalization and symptom severity and duration. In total, 701 participants were randomized to fenofibrate (n = 351) or placebo (n = 350). The mean age of participants was 49 ± 16 years, 330 (47%) were female, mean body mass index was 28 ± 6 kg/m2 and 102 (15%) had diabetes. Death occurred in 41 participants. Compared with placebo, fenofibrate had no effect on the primary endpoint. The median (interquartile range) rank in the placebo arm was 347 (172, 453) versus 345 (175, 453) in the fenofibrate arm (P = 0.819). There was no difference in secondary and exploratory endpoints, including all-cause death, across arms. There were 61 (17%) adverse events in the placebo arm compared with 46 (13%) in the fenofibrate arm, with slightly higher incidence of gastrointestinal side effects in the fenofibrate group. Overall, among patients with COVID-19, fenofibrate has no significant effect on various clinically relevant outcomes ( NCT04517396 ).
Subject(s)

Full text: 1 Collection: 01-internacional Health context: 4_TD / 6_ODS3_enfermedades_notrasmisibles Database: MEDLINE Main subject: Fenofibrate / COVID-19 Type of study: Clinical_trials Limits: Adult / Aged / Female / Humans / Male / Middle aged Language: En Journal: Nat Metab Year: 2022 Document type: Article

Full text: 1 Collection: 01-internacional Health context: 4_TD / 6_ODS3_enfermedades_notrasmisibles Database: MEDLINE Main subject: Fenofibrate / COVID-19 Type of study: Clinical_trials Limits: Adult / Aged / Female / Humans / Male / Middle aged Language: En Journal: Nat Metab Year: 2022 Document type: Article