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FEnofibRate as a Metabolic INtervention for COVID-19 (FERMIN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04517396
Recruitment Status : Completed
First Posted : August 18, 2020
Last Update Posted : November 2, 2022
Sponsor:
Collaborators:
University of Arizona
Universidad Católica de Santa María (National Sponsor in Perú)
Hospital Nacional Adolfo Guevara Velasco, Peru
Hospital Nacional Edgardo Rebagliati Martins
Hospital Nacional Alberto Sabogal Sologuren, Peru
Hospital Nacional Guillermo Almenara Irigoyen, Peru
Hospital Nacional Carlos Alberto Seguin Escobedo - EsSalud
Universidad de Santander, Bucaramanga, Colombia (National Sponsor in Colombia)
National Center for Advancing Translational Sciences (NCATS)
Hospitales Civiles de Guadalajara, Mexico
Hospital 2 de Mayo. Lima, Peru
Hospital de la Fuerza Aérea del Perú. Lima, Peru
Hospital Militar Central "Coronel Luis Arias Schereiber"; Lima, Perú
Hospital Victor Lazarte Echegaray. Lima, Peru
Ioannina University General Hospital. Greece
AHEPA Thessaloniki University General Hospital. Greece
SOTIRIA Athens General University Hospital of Chest Diseases. Greece
THRIASIO Eleusis General Hospital. Greece
Alexandroupolis University General Hospital. Greece
G. GENNIMATAS Athens General Hospital. Greece
Colombia Centro 1: BIOMELAB S.A.S. Barranquilla, Colombia
Fundación Oftalmológica de Santander. Santander, Colombia
IPS Centro Científico Asistencial. Barranquilla, Colombia
Fundación Cardiomet. Quindio, Colombia
Clínica de Marly. Bogotá, Colombia
Clinica Internacional. Lima, Peru
Information provided by (Responsible Party):
Julio A. Chirinos, University of Pennsylvania

Results Submitted - Not Posted on ClinicalTrials.gov
Results information has been submitted to ClinicalTrials.gov by the sponsor or investigator, but is not yet publicly available (or "posted") on ClinicalTrials.gov. The submitted information may not be available if it is pending Quality Control (QC) Review by the National Library of Medicine (NLM) or if issues identified during QC review are being addressed or corrected by the sponsor or investigator. NLM's limited QC review assesses for apparent errors, deficiencies, or inconsistencies. NLM staff do not verify the scientific validity or relevance of the submitted information.
Recruitment Status : Completed
Actual Primary Completion Date : April 30, 2022
Actual Study Completion Date : April 30, 2022
Submission Cycle Results Submitted to ClinicalTrials.gov Results Returned after Quality Control Review
1 December 28, 2022
January 23, 2023
Publications:
Ehrlich E, Uhl S, Ioannidis K, Hofree M, tenOever B, Nahmias Y. The SARS-CoV-2 Transcriptional Metabolic Signature in Lung Epithelium. Cell Sneak Peak (submission only). 2020
PASS 16 Power Analysis and Sample Size Software. NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass. 2018
Therneau TM, Grambsch PM. Modeling Survival Data: Extending the Cox Model. In: Statistics for Biology and Health. New York, NY: Springer; 2001
Little RJ. Modeling the drop-out mechanism in repeated-measures studies. Journal of the American Statistical Association. 1995;90:1112-1121
Ting R-D, Keech A. Fenofibrate and renal disease: clinical effects in diabetes. Clinical Lipidology. 2013;8(6):669-680

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Chirinos JA, Lopez-Jaramillo P, Giamarellos-Bourboulis EJ, Davila-Del-Carpio GH, Bizri AR, Andrade-Villanueva JF, Salman O, Cure-Cure C, Rosado-Santander NR, Cornejo Giraldo MP, Gonzalez-Hernandez LA, Moghnieh R, Angeliki R, Cruz Saldarriaga ME, Pariona M, Medina C, Dimitroulis I, Vlachopoulos C, Gutierrez C, Rodriguez-Mori JE, Gomez-Laiton E, Cotrina Pereyra R, Ravelo Hernandez JL, Arbanil H, Accini-Mendoza J, Perez-Mayorga M, Milionis C, Poulakou G, Sanchez G, Valdivia-Vega R, Villavicencio-Carranza M, Ayala-Garcia RJ, Castro-Callirgos CA, Alfaro Carrasco RM, Garrido Lecca Danos W, Sharkoski T, Greene K, Pourmussa B, Greczylo C, Ortega-Legaspi J, Jacoby D, Chittams J, Katsaounou P, Alexiou Z, Sympardi S, Sweitzer NK, Putt M, Cohen JB; FERMIN Investigators. A randomized clinical trial of lipid metabolism modulation with fenofibrate for acute coronavirus disease 2019. Nat Metab. 2022 Dec;4(12):1847-1857. doi: 10.1038/s42255-022-00698-3. Epub 2022 Nov 7.
Chirinos J, Lopez-Jaramillo P, Giamarellos-Bourboulis E, Davila-Del-Carpio G, Bizri A, Andrade-Villanueva J, Salman O, Cure-Cure C, Rosado-Santander N, Giraldo MC, Gonzalez-Hernandez L, Moghnieh R, Angeliki R, Saldarriaga MC, Pariona M, Medina C, Dimitroulis I, Vlachopoulos C, Gutierrez C, Rodriguez-Mori J, Gomez-Laiton E, Pereyra R, Hernandez JR, Arbanil H, Accini-Mendoza J, Perez-Mayorga M, Milionis H, Poulakou G, Sanchez G, Valdivia-Vega R, Villavicencio-Carranza M, Ayala-Garcia R, Castro-Callirgos C, Carrasco RA, Danos WL, Sharkoski T, Greene K, Pourmussa B, Greczylo C, Chittams J, Katsaounou P, Alexiou Z, Sympardi S, Sweitzer N, Putt M, Cohen J. A Randomized Trial of Lipid Metabolism Modulation with Fenofibrate for Acute Coronavirus Disease 2019. Res Sq. 2022 Aug 10:rs.3.rs-1933913. doi: 10.21203/rs.3.rs-1933913/v1. Preprint.