Fenofibrate for Patients With COVID-19 Requiring Hospitalization
FENOC
A Study of a 10-days Fenofibrate Treatment, or Until Discharge From Hospital, Among COVID-19 Infected Patients Requiring Hospitalization
1 other identifier
interventional
55
1 country
3
Brief Summary
This is an open-label run-in followed by a randomized, double-blind drug treatment study of COVID-19 infected patients requiring inpatient hospital admission.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jan 2021
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 9, 2020
CompletedFirst Posted
Study publicly available on registry
December 10, 2020
CompletedStudy Start
First participant enrolled
January 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2022
CompletedApril 19, 2022
April 1, 2022
1.3 years
December 9, 2020
April 17, 2022
Conditions
Outcome Measures
Primary Outcomes (12)
Number of Therapeutic Oxygen-Free Days
Outcome reported as the mean number of days participants in each arm did not require therapeutic oxygen usage during an in-patient hospital admission.
14 days
Length of Hospital Stay
Outcome reported as the mean length of in-patient hospital stay (in days) for participants in each arm
14 days
Viral Clearance by Nasopharyngeal Swab
Nasopharyngeal swabs will be collected every second day for the duration of study participation. Viral clearance is measured as fold change in viral genetic copies per mL
14 days
Difference in Estimated P/F Ratio at 14 days
Outcome calculated from the partial pressure of oxygen or peripheral saturation of oxygen by pulse oximetry divided by the fraction of inspired oxygen (PaO2 or SaO2 : FiO2 ratio). PaO2 is preferentially used if available.
14 days
Difference in Plasma Neutrophils at 14 days
Blood will be collected every second day for the duration of study participation. Difference will be calculated based on the first measurement after admission to the study.
14 days
Difference in Plasma Lymphocytes at 14 days
Blood will be collected every second day for the duration of study participation. Difference will be calculated based on the first measurement after admission to the study.
14 days
Difference in Plasma Monocytes at 14 days
Blood will be collected every second day for the duration of study participation. Difference will be calculated based on the first measurement after admission to the study.
14 days
Difference in Plasma C-Reactive Protein (CRP) at 14 days
Blood will be collected every second day for the duration of study participation. Difference will be calculated based on the first measurement after admission to the study.
14 days
Difference in Plasma IL-6 at 14 days
Blood will be collected every second day for the duration of study participation. Difference will be calculated based on the first measurement after admission to the study.
14 days
Difference in Plasma Procalcitonin (PCT) at 14 days
Blood will be collected every second day for the duration of study participation. Difference will be calculated based on the first measurement after admission to the study.
14 days
Difference in Plasma Ferritin at 14 days
Blood will be collected every second day for the duration of study participation. Difference will be calculated based on the first measurement after admission to the study.
14 days
Difference in NLR (Neutrophils to Lymphocytes Ratio) at 14 days
Blood will be collected every second day for the duration of study participation. Difference will be calculated based on the first measurement after admission to the study.
14 days
Secondary Outcomes (59)
14-Day Mortality
14 days
Difference in Organ Injury Plasma markers at 14 days - Lactate
14 days
Difference in Organ Injury Plasma markers at 14 days - Cardiac Troponin (TRO)
14 days
Difference in Organ Injury Plasma markers at 14 days - Creatine Kinase (CK)
14 days
Difference in Organ Injury Plasma markers at 14 days - Alanine Aminotransferase (ALT)
14 days
- +54 more secondary outcomes
Other Outcomes (3)
Significant post-acute incident diagnoses after recovery at 28-days
1 day
Significant post-acute incident diagnoses after recovery at 90-days
1 day
Significant post-acute incident diagnoses after recovery at 6-months
1 day
Study Arms (3)
Fenofibrate + Usual Care
EXPERIMENTALParticipants in this arm will receive the study drug, Fenofibrate, in combination with usual care.
Placebo + Usual Care
PLACEBO COMPARATORParticipants in this arm will receive placebo treatment, in combination with usual care.
Usual Care (Observetional)
NO INTERVENTIONParticipants in this arm will receive the usual care and be compared by their medical records and laboratory results
Interventions
Fenofibrate; 145 mg daily (1/day); oral administration; 10 days
Placebo (microcrystalline methylcellulose, gelatin capsule); oral administration
All participants will otherwise receive usual medical care
Eligibility Criteria
You may qualify if:
- Presumptive positive laboratory test for SARS-CoV-2 based on local laboratory standard
- Age greater than or equal to 18 years of age
- Severe COVID-19, defined by:
- A disease severity score of 3 (Hospitalized, on non-invasive ventilation or high flow oxygen devices) to 4 (Hospitalized, requiring supplemental oxygen).
- AND o A respiratory SOFA \>=1 and increased oxygen requirement compared to baseline among those on home O2, a blood oxygen saturation of 93% or less on room air, a ratio of the partial pressure of oxygen to the fraction of inspired oxygen (PaO2/FiO2) of less than 300 mm Hg, respiratory rate \>30 breaths/min, or lung infiltrates \>50% on chest CT
- Enrollment within 72 hours of presentation of hospital admission or within 72 hours of a positive test result, whichever is later
You may not qualify if:
- Enrollment \> 72 hours of admission order or positive test result, whichever is later
- Admission to the hospital with a respiratory SOFA \>=5 , Critical COVID-19, or Disease Severity Score \>5 (requiring extracorporeal membrane oxygenation (ECMO), invasive mechanical ventilation, or all)
- Known hypersensitivity to fenofibrate
- For female subjects:
- Pregenant, determined by a human chorionic gonadotropin (HCG) rapid detection kit or a blood test
- Breastfeeding
- Undergoing fertility treatments
- Patient-reported history or electronic medical record history of kidney disease, defined as:
- Any history of dialysis
- History of chronic kidney disease stage IV
- Estimated Glomerular Filtration Rate (eGFR) of \< 30ml/min/1.73 m2 at the time of enrollment
- Acute pre-renal azotemia at the time of enrollment in the opinion of the investigator or bedside clinician
- Most recent mean arterial blood pressure prior to enrollment \<65 mmHg
- Patient-reported history or electronic medical record history of severe liver disease, defined as:
- Cirrhosis
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yaakov Nahmiaslead
- Barzilai Medical Centercollaborator
- Rambam Health Care Campuscollaborator
- Nazareth Hospitalcollaborator
Study Sites (3)
Barzilai Medical Center
Ashkelon, 7830604, Israel
Rambam Health Care Campus
Haifa, Israel
Nazareth Hospital EMMS
Nazareth, Israel
Related Publications (9)
Bornstein SR, Dalan R, Hopkins D, Mingrone G, Boehm BO. Endocrine and metabolic link to coronavirus infection. Nat Rev Endocrinol. 2020 Jun;16(6):297-298. doi: 10.1038/s41574-020-0353-9.
PMID: 32242089BACKGROUNDEhrlich, A., Uhl, S., Ioannidis, K., Hofree, M., tenOever, B., and Nahmias, Y. (2020). The SARS-CoV-2 Transcriptional Metabolic Signature in Lung Epithelium. SSRN Electronic Journal.
BACKGROUNDMcBride CE, Machamer CE. Palmitoylation of SARS-CoV S protein is necessary for partitioning into detergent-resistant membranes and cell-cell fusion but not interaction with M protein. Virology. 2010 Sep 15;405(1):139-48. doi: 10.1016/j.virol.2010.05.031. Epub 2010 Jul 1.
PMID: 20580052BACKGROUNDWu Q, Zhou L, Sun X, Yan Z, Hu C, Wu J, Xu L, Li X, Liu H, Yin P, Li K, Zhao J, Li Y, Wang X, Li Y, Zhang Q, Xu G, Chen H. Altered Lipid Metabolism in Recovered SARS Patients Twelve Years after Infection. Sci Rep. 2017 Aug 22;7(1):9110. doi: 10.1038/s41598-017-09536-z.
PMID: 28831119BACKGROUNDYan B, Chu H, Yang D, Sze KH, Lai PM, Yuan S, Shuai H, Wang Y, Kao RY, Chan JF, Yuen KY. Characterization of the Lipidomic Profile of Human Coronavirus-Infected Cells: Implications for Lipid Metabolism Remodeling upon Coronavirus Replication. Viruses. 2019 Jan 16;11(1):73. doi: 10.3390/v11010073.
PMID: 30654597BACKGROUNDYang JK, Lin SS, Ji XJ, Guo LM. Binding of SARS coronavirus to its receptor damages islets and causes acute diabetes. Acta Diabetol. 2010 Sep;47(3):193-9. doi: 10.1007/s00592-009-0109-4. Epub 2009 Mar 31.
PMID: 19333547BACKGROUNDYuan S, Chu H, Chan JF, Ye ZW, Wen L, Yan B, Lai PM, Tee KM, Huang J, Chen D, Li C, Zhao X, Yang D, Chiu MC, Yip C, Poon VK, Chan CC, Sze KH, Zhou J, Chan IH, Kok KH, To KK, Kao RY, Lau JY, Jin DY, Perlman S, Yuen KY. SREBP-dependent lipidomic reprogramming as a broad-spectrum antiviral target. Nat Commun. 2019 Jan 10;10(1):120. doi: 10.1038/s41467-018-08015-x.
PMID: 30631056BACKGROUNDZhu L, She ZG, Cheng X, Qin JJ, Zhang XJ, Cai J, Lei F, Wang H, Xie J, Wang W, Li H, Zhang P, Song X, Chen X, Xiang M, Zhang C, Bai L, Xiang D, Chen MM, Liu Y, Yan Y, Liu M, Mao W, Zou J, Liu L, Chen G, Luo P, Xiao B, Zhang C, Zhang Z, Lu Z, Wang J, Lu H, Xia X, Wang D, Liao X, Peng G, Ye P, Yang J, Yuan Y, Huang X, Guo J, Zhang BH, Li H. Association of Blood Glucose Control and Outcomes in Patients with COVID-19 and Pre-existing Type 2 Diabetes. Cell Metab. 2020 Jun 2;31(6):1068-1077.e3. doi: 10.1016/j.cmet.2020.04.021. Epub 2020 May 1.
PMID: 32369736BACKGROUNDEhrlich A, Ioannidis K, Nasar M, Abu Alkian I, Daskal Y, Atari N, Kliker L, Rainy N, Hofree M, Shafran Tikva S, Houri I, Cicero A, Pavanello C, Sirtori CR, Cohen JB, Chirinos JA, Deutsch L, Cohen M, Gottlieb A, Bar-Chaim A, Shibolet O, Mandelboim M, Maayan SL, Nahmias Y. Efficacy and safety of metabolic interventions for the treatment of severe COVID-19: in vitro, observational, and non-randomized open-label interventional study. Elife. 2023 Jan 27;12:e79946. doi: 10.7554/eLife.79946.
PMID: 36705566DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shlomo Mayaan, MD
Barzilai Medical Center
- STUDY DIRECTOR
Mahram Nassar, MD
Barzilai Medical Center
- PRINCIPAL INVESTIGATOR
Yaakov Nahmias, PhD
Hebrew University of Jerusalem
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Director of the Grass Center for Bioengineering
Study Record Dates
First Submitted
December 9, 2020
First Posted
December 10, 2020
Study Start
January 1, 2021
Primary Completion
May 1, 2022
Study Completion
July 1, 2022
Last Updated
April 19, 2022
Record last verified: 2022-04
Data Sharing
- IPD Sharing
- Will not share