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Fenofibrate for Patients With COVID-19 Requiring Hospitalization (FENOC)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04661930
Recruitment Status : Recruiting
First Posted : December 10, 2020
Last Update Posted : April 19, 2022
Sponsor:
Collaborators:
Barzilai Medical Center
Rambam Health Care Campus
Nazareth Hospital
Information provided by (Responsible Party):
Yaakov Nahmias, Hebrew University of Jerusalem

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.

Condition or disease Intervention/treatment Phase
Corona Virus Disease (COVID-19) Respiratory Distress Syndrome SARS-CoV-2 Infection Drug: TriCor® 145mg tablets Other: Placebo Other: Usual care Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 55 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Study of a 10-days Fenofibrate Treatment, or Until Discharge From Hospital, Among COVID-19 Infected Patients Requiring Hospitalization
Actual Study Start Date : January 1, 2021
Estimated Primary Completion Date : May 1, 2022
Estimated Study Completion Date : July 1, 2022


Arm Intervention/treatment
Experimental: Fenofibrate + Usual Care
Participants in this arm will receive the study drug, Fenofibrate, in combination with usual care.
Drug: TriCor® 145mg tablets
Fenofibrate; 145 mg daily (1/day); oral administration; 10 days
Other Name: Lipanthyl NT 145mg tablets

Other: Usual care
All participants will otherwise receive usual medical care

Placebo Comparator: Placebo + Usual Care
Participants in this arm will receive placebo treatment, in combination with usual care.
Other: Placebo
Placebo (microcrystalline methylcellulose, gelatin capsule); oral administration

Other: Usual care
All participants will otherwise receive usual medical care

No Intervention: Usual Care (Observetional)
Participants in this arm will receive the usual care and be compared by their medical records and laboratory results



Primary Outcome Measures :
  1. 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.

  2. 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

  3. 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

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.


Secondary Outcome Measures :
  1. 14-Day Mortality [ Time Frame: 14 days ]
    Outcome reported as the number of participants who have expired at 14 days post enrollment.

  2. Difference in Organ Injury Plasma markers at 14 days - Lactate [ 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.

  3. Difference in Organ Injury Plasma markers at 14 days - Cardiac Troponin (TRO) [ 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.

  4. Difference in Organ Injury Plasma markers at 14 days - Creatine Kinase (CK) [ 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.

  5. Difference in Organ Injury Plasma markers at 14 days - Alanine Aminotransferase (ALT) [ 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.

  6. Difference in Organ Injury Plasma markers at 14 days - Alkaline Phosphatase (ALP) [ 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.

  7. Difference in Organ Injury Plasma markers at 14 days - D-dimer [ 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.

  8. Difference in Organ Injury Plasma markers at 14 days - Platelets (PLT) [ 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.

  9. Number of Abnormal Biomarker Days - D-dimer [ Time Frame: 14 days ]
    Outcome reported as the mean number of days participants in each arm had abnormal plasma levels.

  10. Number of Abnormal Biomarker Days - Neutrophils [ Time Frame: 14 days ]
    Outcome reported as the mean number of days participants in each arm had abnormal plasma levels.

  11. Number of Abnormal Biomarker Days - Lymphocytes [ Time Frame: 14 days ]
    Outcome reported as the mean number of days participants in each arm had abnormal plasma levels.

  12. Number of Abnormal Biomarker Days - Platelets (PLT) [ Time Frame: 14 days ]
    Outcome reported as the mean number of days participants in each arm had abnormal plasma levels.

  13. Number of Abnormal Biomarker Days - Monocytes [ Time Frame: 14 days ]
    Outcome reported as the mean number of days participants in each arm had abnormal plasma levels.

  14. Number of Abnormal Biomarker Days - C-Reactive Protein (CRP) [ Time Frame: 14 days ]
    Outcome reported as the mean number of days participants in each arm had abnormal plasma levels.

  15. Number of Abnormal Biomarker Days - IL-6 [ Time Frame: 14 days ]
    Outcome reported as the mean number of days participants in each arm had 2 or more abnormal plasma levels.

  16. Number of Abnormal Biomarker Days - Procalcitonin (PCT) [ Time Frame: 14 days ]
    Outcome reported as the mean number of days participants in each arm had abnormal plasma levels.

  17. Number of Abnormal Biomarker Days - Lactate [ Time Frame: 14 days ]
    Outcome reported as the mean number of days participants in each arm had abnormal plasma levels.

  18. Number of Abnormal Biomarker Days - Cardiac Troponin (TRO) [ Time Frame: 14 days ]
    Outcome reported as the mean number of days participants in each arm had abnormal plasma levels.

  19. Number of Abnormal Biomarker Days - Creatine Kinase (CK) [ Time Frame: 14 days ]
    Outcome reported as the mean number of days participants in each arm had abnormal plasma levels.

  20. Number of Abnormal Biomarker Days - Alanine Aminotransferase (ALT) [ Time Frame: 14 days ]
    Outcome reported as the mean number of days participants in each arm had abnormal plasma levels.

  21. Number of Abnormal Biomarker Days - Alkaline Phosphatase (ALP) [ Time Frame: 14 days ]
    Outcome reported as the mean number of days participants in each arm had abnormal plasma levels.

  22. Number of Abnormal Biomarker Days - Ferritin [ Time Frame: 14 days ]
    Outcome reported as the mean number of days participants in each arm had abnormal plasma levels.

  23. Difference in Oxygenation at 14 days [ Time Frame: 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

  24. Difference in Estimated PEEP adjusted 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) and Expiratory Pressure.

  25. Daily Hypotensive Episodes [ Time Frame: 14 days ]
    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.

  26. Hypotension Requiring Vasopressors [ Time Frame: 14 days ]
    Outcome reported as the number of participants in each arm requiring the use of vasopressors for hypotension.

  27. Acute Kidney Injury [ Time Frame: 14 days ]
    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.

  28. Sequential Organ Failure Assessment (SOFA) Total Score [ Time Frame: 14 days ]
    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.

  29. Oxygen Saturation / Fractional Inhaled Oxygen (F/S) [ Time Frame: 14 days ]
    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.

  30. 28-Day Mortality [ Time Frame: 28 days ]
    Outcome reported as the number of participants who have expired at 28 days post enrollment.

  31. 90-Day Mortality [ Time Frame: 90 days ]
    Outcome reported as the number of participants who have expired at 90 days post enrollment.

  32. ICU Admission [ Time Frame: 14 days ]
    Outcome reported as the number of participants in each arm who require admission to the Intensive Care Unit (ICU).

  33. Number of Ventilator-Free Days [ Time Frame: 14 days ]
    Outcome reported as the mean number of days participants in each arm did not require mechanical ventilation during an in-patient hospital admission.

  34. Number of Vasopressor-Free Days [ Time Frame: 14 days ]
    Outcome reported as the mean number of days participants in each arm did not require vasopressor usage during an in-patient hospital admission.

  35. Length of ICU Stay [ Time Frame: 14 days ]
    Outcome reported as the mean length of stay (in days) in the Intensive Care Unit (ICU) for participants in each arm.

  36. Incidence of Respiratory Failure [ Time Frame: 14 days ]
    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.

  37. Change in PROMIS Dyspnea Functional Limitations [ Time Frame: 14 days ]
    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.

  38. Change in PROMIS Dyspnea Severity [ Time Frame: 14 days ]
    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.

  39. Disease Severity Rating [ Time Frame: 14 days ]
    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.

  40. Viral Load by Nasopharyngeal Swab [ Time Frame: 14 days ]
    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.

  41. Viral Load by Blood [ Time Frame: 14 days ]
    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.

  42. Viral Clearance by Blood [ Time Frame: 14 days ]
    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.

  43. Abnormal Biomarkers after recovery - D-dimer [ Time Frame: 1 day ]
    Outcome reported as the mean number of days participants in each arm had abnormal plasma levels.

  44. Abnormal Biomarkers after recovery - Neutrophils [ Time Frame: 1 day ]
    Outcome reported as the mean number of days participants in each arm had abnormal plasma levels.

  45. Abnormal Biomarkers after recovery - Lymphocytes [ Time Frame: 1 day ]
    Outcome reported as the mean number of days participants in each arm had abnormal plasma levels.

  46. Abnormal Biomarkers after recovery - Platelets (PLT) [ Time Frame: 1 day ]
    Outcome reported as the mean number of days participants in each arm had abnormal plasma levels.

  47. Abnormal Biomarkers after recovery - Monocytes [ Time Frame: 1 day ]
    Outcome reported as the mean number of days participants in each arm had abnormal plasma levels.

  48. Abnormal Biomarkers after recovery - C-Reactive Protein (CRP) [ Time Frame: 1 day ]
    Outcome reported as the mean number of days participants in each arm had abnormal plasma levels.

  49. Abnormal Biomarkers after recovery - IL-6 [ Time Frame: 1 day ]
    Outcome reported as the mean number of days participants in each arm had abnormal plasma levels.

  50. Abnormal Biomarkers after recovery - Procalcitonin (PCT) [ Time Frame: 1 day ]
    Outcome reported as the mean number of days participants in each arm had abnormal plasma levels.

  51. Abnormal Biomarkers after recovery - Lactate [ Time Frame: 1 day ]
    Outcome reported as the mean number of days participants in each arm had abnormal plasma levels.

  52. Abnormal Biomarkers after recovery - Cardiac Troponin (TRO) [ Time Frame: 1 day ]
    Outcome reported as the mean number of days participants in each arm had abnormal plasma levels.

  53. Abnormal Biomarkers after recovery - Creatine Kinase (CK) [ Time Frame: 1 day ]
    Outcome reported as the mean number of days participants in each arm had abnormal plasma levels.

  54. Abnormal Biomarkers after recovery - Alanine Aminotransferase (ALT) [ Time Frame: 1 day ]
    Outcome reported as the mean number of days participants in each arm had abnormal plasma levels.

  55. Abnormal Biomarkers after recovery - Alkaline Phosphatase (ALP) [ Time Frame: 1 day ]
    Outcome reported as the mean number of days participants in each arm had abnormal plasma levels.

  56. Abnormal Biomarkers after recovery - Ferritin [ Time Frame: 1 day ]
    Outcome reported as the mean number of days participants in each arm had abnormal plasma levels.

  57. Abnormal Oxygenation after recovery [ Time Frame: 1 day ]
    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

  58. PROMIS Dyspnea Functional Limitations after recovery [ Time Frame: 1 day ]
    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.

  59. PROMIS Dyspnea Severity after recovery [ Time Frame: 1 day ]
    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.


Other Outcome Measures:
  1. Significant post-acute incident diagnoses after recovery at 28-days [ Time Frame: 1 day ]
    Incident rate per 1000 at 28-days in hospitalized COVID-19 is ascertained from hospital admission until 28-days or end of follow-up.

  2. Significant post-acute incident diagnoses after recovery at 90-days [ Time Frame: 1 day ]
    Incident rate per 1000 at 90-days in hospitalized COVID-19 is ascertained from hospital admission until 90-days or end of follow-up.

  3. Significant post-acute incident diagnoses after recovery at 6-months [ Time Frame: 1 day ]
    Incident rate per 1000 at 6-months in hospitalized COVID-19 is ascertained from hospital admission until 6-months or end of follow-up.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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:

    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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04661930


Contacts
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Contact: Yaakov Nahmias, PhD +972-2-5494640 ynahmias@cs.huji.ac.il
Contact: Avner Ehrlich +972-54-3181422 avner.ehrlich@mail.huji.ac.il

Locations
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Israel
Barzilai Medical Center Recruiting
Ashkelon, Israel, 7830604
Contact: Shlomo Maayan, MD         
Rambam Health Care Campus Recruiting
Haifa, Israel
Contact: Shadi Hamoud, Prof. MD.    04-7773097    s_hamoud@rmc.gov.il   
Principal Investigator: Shadi Hamoud, Prof. MD.         
Nazareth Hospital EMMS Recruiting
Nazareth, Israel
Contact: Amir Alimi, MD         
Principal Investigator: Amir Alimi, MD         
Sponsors and Collaborators
Yaakov Nahmias
Barzilai Medical Center
Rambam Health Care Campus
Nazareth Hospital
Investigators
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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
Publications:
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.

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Responsible Party: Yaakov Nahmias, Director of the Grass Center for Bioengineering, Hebrew University of Jerusalem
ClinicalTrials.gov Identifier: NCT04661930    
Other Study ID Numbers: 0105-20-BRZ; FENOC-005
First Posted: December 10, 2020    Key Record Dates
Last Update Posted: April 19, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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COVID-19
Fenofibrate
Virus Diseases
Respiratory Distress Syndrome
Respiratory Distress Syndrome, Newborn
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents