Corona Virus Disease (COVID-19)Phase 3FENOCNCT04661930

Fenofibrate for Patients With COVID-19 Requiring Hospitalization

A Phase 3 study testing TriCor® 145mg tablets in people with Corona Virus Disease (COVID-19) and Respiratory Distress Syndrome, run by Yaakov Nahmias at 3 sites in Israel.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 85 years
Conditions the study is for: Corona Virus Disease (COVID-19), Respiratory Distress Syndrome, SARS-CoV-2 Infection
What is being tested?: TriCor® 145mg tablets
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 55 participants
Where: 3 sitesIsrael
Study dates: 1 Jan 2021to 1 Jul 2022
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

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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
History of hepatitis B or C
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

Trial locations and contacts

3 sites in 1 country.

Yaakov Nahmias, PhD contact

+972-2-5494640

ynahmias@cs.huji.ac.il

Avner Ehrlich contact

+972-54-3181422

avner.ehrlich@mail.huji.ac.il

Israel3 sites, 3 recruiting

Barzilai Medical Center
Ashkelon, 7830604
Shlomo Maayan, MD
Recruiting
Rambam Health Care Campus
Haifa
Shadi Hamoud, Prof. MD., 04-7773097, s_hamoud@rmc.gov.il
Shadi Hamoud, Prof. MD.
Recruiting
Nazareth Hospital EMMS
Nazareth
Amir Alimi, MD
Amir Alimi, MD
Recruiting

Other trials in Israel

About this study

Official title: A Study of a 10-days Fenofibrate Treatment, or Until Discharge From Hospital, Among COVID-19 Infected Patients Requiring Hospitalization

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.

Read the detailed description

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. Open-label patients will be matched at least 1:10 with observational retrospective Propensity score-matched (PSM) patients' medical files. The double-blinded step will be randomized 2:1 to daily Fenofibrate or placebo for 10 days or hospital discharge.

Conditions: Corona Virus Disease (COVID-19), Respiratory Distress Syndrome, SARS-CoV-2 Infection
Being tested: TriCor® 145mg tablets, Placebo, Usual care
Medical subject headings: COVID-19, Respiratory Distress Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TriCor® 145mg tabletsDrug
Also called Lipanthyl NT 145mg tablets
Fenofibrate; 145 mg daily (1/day); oral administration; 10 days
PlaceboOther
Placebo (microcrystalline methylcellulose, gelatin capsule); oral administration
Usual careOther
All participants will otherwise receive usual medical care

Study groups in NCT04661930
Study group	Role	What they receive
Fenofibrate + Usual Care	Experimental	Participants in this arm will receive the study drug, Fenofibrate, in combination with usual care. Receives: Drug: TriCor® 145mg tablets; Other: Usual care
Placebo + Usual Care	Placebo comparator	Participants in this arm will receive placebo treatment, in combination with usual care. Receives: Other: Placebo; Other: Usual care
Usual Care (Observetional)	No intervention	Participants in this arm will receive the usual care and be compared by their medical records and laboratory results

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 14 days
Length of Hospital Stay
Outcome reported as the mean length of in-patient hospital stay (in days) for participants in each arm
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 14 days

Secondary outcomes (59)

14-Day Mortality
Outcome reported as the number of participants who have expired at 14 days post enrollment.
Measured: 14 days
Difference in Organ Injury Plasma markers at 14 days - Lactate
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.
Measured: 14 days
Difference in Organ Injury Plasma markers at 14 days - Cardiac Troponin (TRO)
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.
Measured: 14 days
Difference in Organ Injury Plasma markers at 14 days - Creatine Kinase (CK)
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.
Measured: 14 days
Difference in Organ Injury Plasma markers at 14 days - Alanine Aminotransferase (ALT)
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.
Measured: 14 days
Difference in Organ Injury Plasma markers at 14 days - Alkaline Phosphatase (ALP)
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.
Measured: 14 days
Difference in Organ Injury Plasma markers at 14 days - D-dimer
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.
Measured: 14 days
Difference in Organ Injury Plasma markers at 14 days - Platelets (PLT)
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.
Measured: 14 days
Number of Abnormal Biomarker Days - D-dimer
Outcome reported as the mean number of days participants in each arm had abnormal plasma levels.
Measured: 14 days
Number of Abnormal Biomarker Days - Neutrophils
Outcome reported as the mean number of days participants in each arm had abnormal plasma levels.
Measured: 14 days
Number of Abnormal Biomarker Days - Lymphocytes
Outcome reported as the mean number of days participants in each arm had abnormal plasma levels.
Measured: 14 days
Number of Abnormal Biomarker Days - Platelets (PLT)
Outcome reported as the mean number of days participants in each arm had abnormal plasma levels.
Measured: 14 days
Number of Abnormal Biomarker Days - Monocytes
Outcome reported as the mean number of days participants in each arm had abnormal plasma levels.
Measured: 14 days
Number of Abnormal Biomarker Days - C-Reactive Protein (CRP)
Outcome reported as the mean number of days participants in each arm had abnormal plasma levels.
Measured: 14 days
Number of Abnormal Biomarker Days - IL-6
Outcome reported as the mean number of days participants in each arm had 2 or more abnormal plasma levels.
Measured: 14 days
Number of Abnormal Biomarker Days - Procalcitonin (PCT)
Outcome reported as the mean number of days participants in each arm had abnormal plasma levels.
Measured: 14 days
Number of Abnormal Biomarker Days - Lactate
Outcome reported as the mean number of days participants in each arm had abnormal plasma levels.
Measured: 14 days
Number of Abnormal Biomarker Days - Cardiac Troponin (TRO)
Outcome reported as the mean number of days participants in each arm had abnormal plasma levels.
Measured: 14 days
Number of Abnormal Biomarker Days - Creatine Kinase (CK)
Outcome reported as the mean number of days participants in each arm had abnormal plasma levels.
Measured: 14 days
Number of Abnormal Biomarker Days - Alanine Aminotransferase (ALT)
Outcome reported as the mean number of days participants in each arm had abnormal plasma levels.
Measured: 14 days
Number of Abnormal Biomarker Days - Alkaline Phosphatase (ALP)
Outcome reported as the mean number of days participants in each arm had abnormal plasma levels.
Measured: 14 days
Number of Abnormal Biomarker Days - Ferritin
Outcome reported as the mean number of days participants in each arm had abnormal plasma levels.
Measured: 14 days
Difference in Oxygenation at 14 days
PaO2 or SaO2 and FiO2. Partial pressure of oxygen or peripheral saturation of oxygen by pulse oximetry. FiO₂ is estimated from oxygen flow/delivery rates
Measured: 14 days
Difference in Estimated PEEP adjusted 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) and Expiratory Pressure.
Measured: 14 days
Daily Hypotensive Episodes
Outcome reported as the mean number of daily hypotensive episodes (MAP < 65 mmHg) prompting intervention (indicated by a fluid bolus >=500 mL, new treatment with pressures, increase in 50% pressure or fluid rate) per participant in each arm.
Measured: 14 days
Hypotension Requiring Vasopressors
Outcome reported as the number of participants in each arm requiring the use of vasopressors for hypotension.
Measured: 14 days
Acute Kidney Injury
Outcome reported as the number of participants in each arm who experience acute kidney injury as defined by the Kidney Disease Improving Global Outcomes (KDIGO) guidelines: Increase in serum creatinine by 0.3mg/dL or more within 48 hours OR Increase in serum creatinine to 1.5 times baseline or more within the last 7 days OR Urine output less than 0.5 mL/kg/h for 6 hours.
Measured: 14 days
Sequential Organ Failure Assessment (SOFA) Total Score
The SOFA assessment is used to track a person's risk status during stay in the Intensive Care Unit (ICU). The score is based on six different scores, one each for the respiratory, cardiovascular, hepatic, coagulation, renal, and neurological systems. Each organ system is assigned a point value from 0 (normal) to 4 (high degree of dysfunction/failure). Total score is calculated by entering patient data into a SOFA calculator, a widely available software. Total scores range from 0-24, with higher scores indicating greater risk of mortality.
Measured: 14 days
Oxygen Saturation / Fractional Inhaled Oxygen (F/S)
Oxygen saturation (percent) is measured by pulse oximeter. Fraction of inspired oxygen (FiO2) (unitless) is the volumetric fraction of oxygen to other gases in respiratory support. The F/S ratio is unitless.
Measured: 14 days
28-Day Mortality
Outcome reported as the number of participants who have expired at 28 days post enrollment.
Measured: 28 days
90-Day Mortality
Outcome reported as the number of participants who have expired at 90 days post enrollment.
Measured: 90 days
ICU Admission
Outcome reported as the number of participants in each arm who require admission to the Intensive Care Unit (ICU).
Measured: 14 days
Number of Ventilator-Free Days
Outcome reported as the mean number of days participants in each arm did not require mechanical ventilation during an in-patient hospital admission.
Measured: 14 days
Number of Vasopressor-Free Days
Outcome reported as the mean number of days participants in each arm did not require vasopressor usage during an in-patient hospital admission.
Measured: 14 days
Length of ICU Stay
Outcome reported as the mean length of stay (in days) in the Intensive Care Unit (ICU) for participants in each arm.
Measured: 14 days
Incidence of Respiratory Failure
Outcome reported as the number of participants requiring BiPAP OR high flow nasal cannula OR mechanical ventilation OR extracorporeal membranous oxygenation (ECMO) utilization during in-patient hospital care in each arm.
Measured: 14 days
Change in PROMIS Dyspnea Functional Limitations
The PROMIS Dyspnea (shortness of breath) item banks and pools assess self-reported Functional Limitations, Severity, Activity Motivation, Activity Requirements, Airborne Exposure, Assistant Devices Resources, Characteristics, Emotional Response, Task Avoidance and Time Extension as they related to dyspnea. In the 33-item Functional Limitations bank, 33 daily activities are rated in terms of degree of difficulty while engaging in the activity over the past 7 days (0 = no difficulty, 1 = a little difficulty, 2 = some difficulty, 3 = much difficulty). Total scores range from 0 to 99, with higher scores reflecting greater functional limitations.
Measured: 14 days
Change in PROMIS Dyspnea Severity
The PROMIS Dyspnea (shortness of breath) item banks and pools assess self-reported Functional Limitations, Severity, Activity Motivation, Activity Requirements, Airborne Exposure, Assistant Devices Resources, Characteristics, Emotional Response, Task Avoidance and Time Extension as they related to dyspnea. The 33-item Severity bank assesses the severity of difficulty breathing during various specific activities (the same 33 activities assessed in Dyspnea Functional Limitations). Each activity is rated in terms of degree of dyspnea (0 = no shortness of breath, 1 = mildly short of breath, 2 = moderately short of breath, 3 = severely short of breath) while engaging in the activity over the past 7 days. Total scores range from 0 to 99 with higher scores reflecting greater levels of dyspnea during daily activity.
Measured: 14 days
Disease Severity Rating
Outcome reported as the number of participants in each arm who fall into each of 7 categories. Lower scores indicate greater condition severity. The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen; 6) Not hospitalized, limitation on activities; 7) Not hospitalized, no limitations on activities.
Measured: 14 days
Viral Load by Nasopharyngeal Swab
Nasopharyngeal swabs will be collected every fourth day for the duration of study participation. Viral load is measured as number of viral genetic copies per mL.
Measured: 14 days
Viral Load by Blood
Blood will be collected every third day for viral load assessment for the duration of study participation. Viral load is measured as number of viral genetic copies per mL.
Measured: 14 days
Viral Clearance by Blood
Blood will be collected every third day for viral load assessment for the duration of study participation. clearance is measured as fold change in viral genetic copies per mL.
Measured: 14 days
Abnormal Biomarkers after recovery - D-dimer
Outcome reported as the mean number of days participants in each arm had abnormal plasma levels.
Measured: 1 day
Abnormal Biomarkers after recovery - Neutrophils
Outcome reported as the mean number of days participants in each arm had abnormal plasma levels.
Measured: 1 day
Abnormal Biomarkers after recovery - Lymphocytes
Outcome reported as the mean number of days participants in each arm had abnormal plasma levels.
Measured: 1 day
Abnormal Biomarkers after recovery - Platelets (PLT)
Outcome reported as the mean number of days participants in each arm had abnormal plasma levels.
Measured: 1 day
Abnormal Biomarkers after recovery - Monocytes
Outcome reported as the mean number of days participants in each arm had abnormal plasma levels.
Measured: 1 day
Abnormal Biomarkers after recovery - C-Reactive Protein (CRP)
Outcome reported as the mean number of days participants in each arm had abnormal plasma levels.
Measured: 1 day
Abnormal Biomarkers after recovery - IL-6
Outcome reported as the mean number of days participants in each arm had abnormal plasma levels.
Measured: 1 day
Abnormal Biomarkers after recovery - Procalcitonin (PCT)
Outcome reported as the mean number of days participants in each arm had abnormal plasma levels.
Measured: 1 day
Abnormal Biomarkers after recovery - Lactate
Outcome reported as the mean number of days participants in each arm had abnormal plasma levels.
Measured: 1 day
Abnormal Biomarkers after recovery - Cardiac Troponin (TRO)
Outcome reported as the mean number of days participants in each arm had abnormal plasma levels.
Measured: 1 day
Abnormal Biomarkers after recovery - Creatine Kinase (CK)
Outcome reported as the mean number of days participants in each arm had abnormal plasma levels.
Measured: 1 day
Abnormal Biomarkers after recovery - Alanine Aminotransferase (ALT)
Outcome reported as the mean number of days participants in each arm had abnormal plasma levels.
Measured: 1 day
Abnormal Biomarkers after recovery - Alkaline Phosphatase (ALP)
Outcome reported as the mean number of days participants in each arm had abnormal plasma levels.
Measured: 1 day
Abnormal Biomarkers after recovery - Ferritin
Outcome reported as the mean number of days participants in each arm had abnormal plasma levels.
Measured: 1 day
Abnormal Oxygenation after recovery
Outcome reported as the mean number of participants in each arm had abnormal PaO2 or SaO2 and FiO2 levels at the end of quarantine period. Partial pressure of oxygen or peripheral saturation of oxygen by pulse oximetry. FiO₂ is estimated from oxygen flow/delivery rates
Measured: 1 day
PROMIS Dyspnea Functional Limitations after recovery
The PROMIS Dyspnea (shortness of breath) item banks and pools assess self-reported Functional Limitations, Severity, Activity Motivation, Activity Requirements, Airborne Exposure, Assistant Devices Resources, Characteristics, Emotional Response, Task Avoidance and Time Extension as they related to dyspnea. In the 33-item Functional Limitations bank, 33 daily activities are rated in terms of degree of difficulty while engaging in the activity over the past 7 days (0 = no difficulty, 1 = a little difficulty, 2 = some difficulty, 3 = much difficulty). Total scores range from 0 to 99, with higher scores reflecting greater functional limitations. Measured at the end of quarantine period.
Measured: 1 day
PROMIS Dyspnea Severity after recovery
The PROMIS Dyspnea (shortness of breath) item banks and pools assess self-reported Functional Limitations, Severity, Activity Motivation, Activity Requirements, Airborne Exposure, Assistant Devices Resources, Characteristics, Emotional Response, Task Avoidance and Time Extension as they related to dyspnea. The 33-item Severity bank assesses the severity of difficulty breathing during various specific activities (the same 33 activities assessed in Dyspnea Functional Limitations). Each activity is rated in terms of degree of dyspnea (0 = no shortness of breath, 1 = mildly short of breath, 2 = moderately short of breath, 3 = severely short of breath) while engaging in the activity over the past 7 days. Total scores range from 0 to 99 with higher scores reflecting greater levels of dyspnea during daily activity. Measured at the end of quarantine period.
Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 20211 Jul 2022

First posted10 Dec 2020
Study start1 Jan 2021
Primary completion1 May 2022 (estimated)
Study completion1 Jul 2022 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (9)Papers the sponsor has linked to this study.
Other trials for Corona Virus Disease (COVID-19)Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: An interventional single-arm non-randomized pilot study in 15 patients, followed by an Interventional double-blinded randomized quadruple masked study in 40 patients.
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 55 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04661930
Sponsor's protocol ID: 0105-20-BRZ; FENOC-005
Acronym: FENOC
Status last verified: Apr 2022
First submitted: 9 Dec 2020
Last updated: 19 Apr 2022
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 32242089
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.
PubMed 20580052
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.
PubMed 28831119
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.
PubMed 30654597
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.
PubMed 19333547
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.
PubMed 30631056
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.
PubMed 32369736
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.
PubMed 36705566

Study at a glance

From the registry record, last updated by the sponsor on 19 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study of a 10-days Fenofibrate Treatment, or Until Discharge From Hospital, Among COVID-19 Infected Patients Requiring Hospitalization
ClinicalTrials.gov ID: NCT04661930
Acronym / sponsor ID: FENOC / 0105-20-BRZ; FENOC-005
Conditions: Corona Virus Disease (COVID-19), Respiratory Distress Syndrome, SARS-CoV-2 Infection
Phase: Phase 3
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 55 participants (estimated)
Lead sponsor: Yaakov NahmiasUniversity, hospital or other
Collaborators: Barzilai Medical Center, Rambam Health Care Campus, Nazareth Hospital
Study start: 1 Jan 2021 (actual)
Primary completion: 1 May 2022 (estimated)
Study completion: 1 Jul 2022 (estimated)
First posted: 10 Dec 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3
Model description: An interventional single-arm non-randomized pilot study in 15 patients, followed by an Interventional double-blinded randomized quadruple masked study in 40 patients.

Arm	Type	Receives
Fenofibrate + Usual Care	Experimental	Drug: TriCor® 145mg tablets, Other: Usual careParticipants in this arm will receive the study drug, Fenofibrate, in combination with usual care.
Placebo + Usual Care	Placebo comparator	Other: Placebo, Other: Usual careParticipants in this arm will receive placebo treatment, in combination with usual care.
Usual Care (Observetional)	No intervention	–Participants in this arm will receive the usual care and be compared by their medical records and laboratory results

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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:
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

Key exclusion criteria (22 listed)

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:
Patient-reported history or electronic medical record history of kidney disease, defined as:

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TriCor® 145mg tabletsAlso: Lipanthyl NT 145mg tabletsFenofibrate; 145 mg daily (1/day); oral administration; 10 days	Drug	Fenofibrate + Usual Care
PlaceboPlacebo (microcrystalline methylcellulose, gelatin capsule); oral administration	Other	Placebo + Usual Care
Usual careAll participants will otherwise receive usual medical care	Other	Fenofibrate + Usual Care, Placebo + Usual Care

Primary outcome

Number of Therapeutic Oxygen-Free Days
Time frame: 14 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.
Length of Hospital Stay
Time frame: 14 days
Outcome reported as the mean length of in-patient hospital stay (in days) for participants in each arm
Viral Clearance by Nasopharyngeal Swab
Time frame: 14 days
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
Difference in Estimated P/F Ratio at 14 days
Time frame: 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.
Difference in Plasma Neutrophils at 14 days
Time frame: 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.
Difference in Plasma Lymphocytes at 14 days
Time frame: 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.
Difference in Plasma Monocytes at 14 days
Time frame: 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.
Difference in Plasma C-Reactive Protein (CRP) at 14 days
Time frame: 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.
Difference in Plasma IL-6 at 14 days
Time frame: 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.
Difference in Plasma Procalcitonin (PCT) at 14 days
Time frame: 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.
Difference in Plasma Ferritin at 14 days
Time frame: 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.
Difference in NLR (Neutrophils to Lymphocytes Ratio) at 14 days
Time frame: 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.

59 secondary outcomes

14-Day Mortality
Time frame: 14 days
Difference in Organ Injury Plasma markers at 14 days - Lactate
Time frame: 14 days
Difference in Organ Injury Plasma markers at 14 days - Cardiac Troponin (TRO)
Time frame: 14 days
Difference in Organ Injury Plasma markers at 14 days - Creatine Kinase (CK)
Time frame: 14 days
Difference in Organ Injury Plasma markers at 14 days - Alanine Aminotransferase (ALT)
Time frame: 14 days
Difference in Organ Injury Plasma markers at 14 days - Alkaline Phosphatase (ALP)
Time frame: 14 days
Difference in Organ Injury Plasma markers at 14 days - D-dimer
Time frame: 14 days
Difference in Organ Injury Plasma markers at 14 days - Platelets (PLT)
Time frame: 14 days
Number of Abnormal Biomarker Days - D-dimer
Time frame: 14 days
Number of Abnormal Biomarker Days - Neutrophils
Time frame: 14 days
Number of Abnormal Biomarker Days - Lymphocytes
Time frame: 14 days
Number of Abnormal Biomarker Days - Platelets (PLT)
Time frame: 14 days
Number of Abnormal Biomarker Days - Monocytes
Time frame: 14 days
Number of Abnormal Biomarker Days - C-Reactive Protein (CRP)
Time frame: 14 days
Number of Abnormal Biomarker Days - IL-6
Time frame: 14 days
Number of Abnormal Biomarker Days - Procalcitonin (PCT)
Time frame: 14 days
Number of Abnormal Biomarker Days - Lactate
Time frame: 14 days
Number of Abnormal Biomarker Days - Cardiac Troponin (TRO)
Time frame: 14 days
Number of Abnormal Biomarker Days - Creatine Kinase (CK)
Time frame: 14 days
Number of Abnormal Biomarker Days - Alanine Aminotransferase (ALT)
Time frame: 14 days
Number of Abnormal Biomarker Days - Alkaline Phosphatase (ALP)
Time frame: 14 days
Number of Abnormal Biomarker Days - Ferritin
Time frame: 14 days
Difference in Oxygenation at 14 days
Time frame: 14 days
Difference in Estimated PEEP adjusted P/F Ratio at 14 days
Time frame: 14 days
Daily Hypotensive Episodes
Time frame: 14 days
Hypotension Requiring Vasopressors
Time frame: 14 days
Acute Kidney Injury
Time frame: 14 days
Sequential Organ Failure Assessment (SOFA) Total Score
Time frame: 14 days
Oxygen Saturation / Fractional Inhaled Oxygen (F/S)
Time frame: 14 days
28-Day Mortality
Time frame: 28 days
90-Day Mortality
Time frame: 90 days
ICU Admission
Time frame: 14 days
Number of Ventilator-Free Days
Time frame: 14 days
Number of Vasopressor-Free Days
Time frame: 14 days
Length of ICU Stay
Time frame: 14 days
Incidence of Respiratory Failure
Time frame: 14 days
Change in PROMIS Dyspnea Functional Limitations
Time frame: 14 days
Change in PROMIS Dyspnea Severity
Time frame: 14 days
Disease Severity Rating
Time frame: 14 days
Viral Load by Nasopharyngeal Swab
Time frame: 14 days

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2022.
Background: PubMed 32242089Bornstein 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.
BackgroundEhrlich, 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.
Background: PubMed 20580052McBride 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.
Background: PubMed 28831119Wu 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.
Background: PubMed 30654597Yan 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.
Background: PubMed 19333547Yang 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.
Background: PubMed 30631056Yuan 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.
Background: PubMed 32369736Zhu 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.
Derived from this study: PubMed 36705566Ehrlich 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.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Yaakov Nahmias, PhD contact

+972-2-5494640

ynahmias@cs.huji.ac.il

Avner Ehrlich contact

+972-54-3181422

avner.ehrlich@mail.huji.ac.il

Shlomo Mayaan, MD principal investigator

Barzilai Medical Center

Mahram Nassar, MD study director

Barzilai Medical Center

Yaakov Nahmias, PhD principal investigator

Hebrew University of Jerusalem

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing TriCor® 145mg tablets in people with Corona Virus Disease (COVID-19) and Respiratory Distress Syndrome, run by Yaakov Nahmias at 3 sites in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 19 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Yaakov Nahmias, PhD (+972-2-5494640, ynahmias@cs.huji.ac.il), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Therapeutic Oxygen-Free Days (time frame: 14 days). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04661930, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2022; AzTrials last refreshed its copy on 7 Nov 2026.