Fenofibrate for Patients With COVID-19 Requiring Hospitalization
NCT ID: NCT04661930
Last Updated: 2022-04-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
55 participants
INTERVENTIONAL
2021-01-01
2022-07-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Fenofibrate + Usual Care
Participants in this arm will receive the study drug, Fenofibrate, in combination with usual care.
TriCor® 145mg tablets
Fenofibrate; 145 mg daily (1/day); oral administration; 10 days
Usual care
All participants will otherwise receive usual medical care
Placebo + Usual Care
Participants in this arm will receive placebo treatment, in combination with usual care.
Placebo
Placebo (microcrystalline methylcellulose, gelatin capsule); oral administration
Usual care
All participants will otherwise receive usual medical care
Usual Care (Observetional)
Participants in this arm will receive the usual care and be compared by their medical records and laboratory results
No interventions assigned to this group
Interventions
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TriCor® 145mg tablets
Fenofibrate; 145 mg daily (1/day); oral administration; 10 days
Placebo
Placebo (microcrystalline methylcellulose, gelatin capsule); oral administration
Usual care
All participants will otherwise receive usual medical care
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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:
1. Pregenant, determined by a human chorionic gonadotropin (HCG) rapid detection kit or a blood test
2. Breastfeeding
3. Undergoing fertility treatments
* Patient-reported history or electronic medical record history of kidney disease, defined as:
1. Any history of dialysis
2. History of chronic kidney disease stage IV
3. 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:
1. Cirrhosis
2. History of hepatitis B or C
3. Documented AST or ALT \> 10 times the upper limit of normal measured within 24 hours prior to enrollment
* Patient-reported history or electronic medical record history of gallbladder disease
* Potassium \>5.0 within 24 hours prior to enrollment unless a repeat value was \<=5.0
* Treatment with coumarin anticoagulants (e.g., Warfarin), immunosuppressants (e.g. cisplatin), bile acid resins, or sulfonylurea.
* Inability to obtain informed consent from participant or legally authorized representative
* Enrollment in another blinded randomized clinical trial for COVID
18 Years
85 Years
ALL
No
Sponsors
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Barzilai Medical Center
OTHER
Rambam Health Care Campus
OTHER
Nazareth Hospital
OTHER
Yaakov Nahmias
OTHER
Responsible Party
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Yaakov Nahmias
Director of the Grass Center for Bioengineering
Principal Investigators
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Shlomo Mayaan, MD
Role: PRINCIPAL_INVESTIGATOR
Barzilai Medical Center
Mahram Nassar, MD
Role: STUDY_DIRECTOR
Barzilai Medical Center
Yaakov Nahmias, PhD
Role: PRINCIPAL_INVESTIGATOR
Hebrew University of Jerusalem
Locations
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Barzilai Medical Center
Ashkelon, , Israel
Rambam Health Care Campus
Haifa, , Israel
Nazareth Hospital EMMS
Nazareth, , Israel
Countries
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Central Contacts
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Facility Contacts
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Shlomo Maayan, MD
Role: primary
Amir Alimi, MD
Role: primary
References
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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.
Ehrlich, 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.
McBride 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.
Wu 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.
Yan 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.
Yang 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.
Yuan 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.
Zhu 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.
Ehrlich 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.
Other Identifiers
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0105-20-BRZ; FENOC-005
Identifier Type: -
Identifier Source: org_study_id
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