Trial Outcomes & Findings for FEnofibRate as a Metabolic INtervention for COVID-19 (NCT NCT04517396)

Last Updated: 2023-03-24

Results Overview

The primary endpoint of the trial is a global rank score that ranks patient outcomes according to 5 factors. The global rank score, or global severity score, is a nonparametric, hierarchically ranked outcome. The global rank score was generated by ranking all 701 participants on a scale of 1 to 701, from worst to best clinical outcomes. Participants were ranked by (1) time to death; (2) the number of days supported by invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); (3) The inspired concentration of oxygen/percent oxygen saturation (FiO2/SpO2) ratio area under the curve; (4) For participants enrolled as outpatients who are subsequently hospitalized, the number of days out of the hospital during the 30 day-period following randomization; (5) For participants enrolled as outpatients who don't get hospitalized during the 30-day observation period, the modified Borg dyspnea scale

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

701 participants

Primary outcome timeframe

30 days

Results posted on

2023-03-24

Participant Flow

Participant milestones

Participant milestones
Measure	Fenofibrate + Usual Care The randomized intervention will be Fenofibrate, in combination with usual care. Dosing: 145 mg of Tricor or a dose-equivalent preparation Fenofibrate/fenofibric acid: The randomized intervention will be fenofibrate (Tricor) at a dose of 145 mg/d or dose-equivalent preparation of fenofibrate or fenofibric acid, for 10 days. In all cases, appropriate dose reductions will be implemented for patients with chronic kidney disease as per the approved preparation label. The intended duration of randomized treatment will be for 10 days. Usual care: All participants will otherwise receive usual medical care	Placebo + Usual Care The randomized intervention will a matching placebo, in combination with usual care. Placebo: The control intervention will be a placebo, for 10 days. Usual care: All participants will otherwise receive usual medical care
Overall Study STARTED	351	350
Overall Study COMPLETED	347	347
Overall Study NOT COMPLETED	4	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

FEnofibRate as a Metabolic INtervention for COVID-19

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Fenofibrate + Usual Care n=351 Participants The randomized intervention will be Fenofibrate, in combination with usual care. Dosing: 145 mg of Tricor or a dose-equivalent preparation Fenofibrate/fenofibric acid: The randomized intervention will be fenofibrate (Tricor) at a dose of 145 mg/d or dose-equivalent preparation of fenofibrate or fenofibric acid, for 10 days. In all cases, appropriate dose reductions will be implemented for patients with chronic kidney disease as per the approved preparation label. The intended duration of randomized treatment will be for 10 days. Usual care: All participants will otherwise receive usual medical care	Placebo + Usual Care n=350 Participants The randomized intervention will a matching placebo, in combination with usual care. Placebo: The control intervention will be a placebo, for 10 days. Usual care: All participants will otherwise receive usual medical care	Total n=701 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	293 Participants n=5 Participants	289 Participants n=7 Participants	582 Participants n=5 Participants
Age, Categorical >=65 years	58 Participants n=5 Participants	61 Participants n=7 Participants	119 Participants n=5 Participants
Sex: Female, Male Female	164 Participants n=5 Participants	166 Participants n=7 Participants	330 Participants n=5 Participants
Sex: Female, Male Male	187 Participants n=5 Participants	184 Participants n=7 Participants	371 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	173 Participants n=5 Participants	177 Participants n=7 Participants	350 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	178 Participants n=5 Participants	173 Participants n=7 Participants	351 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	24 Participants n=5 Participants	25 Participants n=7 Participants	49 Participants n=5 Participants
Race (NIH/OMB) White	168 Participants n=5 Participants	170 Participants n=7 Participants	338 Participants n=5 Participants
Race (NIH/OMB) More than one race	133 Participants n=5 Participants	134 Participants n=7 Participants	267 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	21 Participants n=5 Participants	20 Participants n=7 Participants	41 Participants n=5 Participants
Region of Enrollment United States	57 participants n=5 Participants	59 participants n=7 Participants	116 participants n=5 Participants
Region of Enrollment Mexico	34 participants n=5 Participants	33 participants n=7 Participants	67 participants n=5 Participants
Region of Enrollment Peru	58 participants n=5 Participants	58 participants n=7 Participants	116 participants n=5 Participants
Region of Enrollment Colombia	79 participants n=5 Participants	77 participants n=7 Participants	156 participants n=5 Participants
Region of Enrollment Greece	67 participants n=5 Participants	66 participants n=7 Participants	133 participants n=5 Participants
Region of Enrollment Lebanon	56 participants n=5 Participants	57 participants n=7 Participants	113 participants n=5 Participants
Borg Scale	2.6 units on a scale STANDARD_DEVIATION 2.8 • n=5 Participants	2.9 units on a scale STANDARD_DEVIATION 3.1 • n=7 Participants	2.7 units on a scale STANDARD_DEVIATION 3.0 • n=5 Participants

PRIMARY outcome

Timeframe: 30 days

Outcome measures

Outcome measures
Measure	Fenofibrate + Usual Care n=351 Participants The randomized intervention will be Fenofibrate, in combination with usual care. Dosing: 145 mg of Tricor or a dose-equivalent preparation Fenofibrate/fenofibric acid: The randomized intervention will be fenofibrate (Tricor) at a dose of 145 mg/d or dose-equivalent preparation of fenofibrate or fenofibric acid, for 10 days. In all cases, appropriate dose reductions will be implemented for patients with chronic kidney disease as per the approved preparation label. The intended duration of randomized treatment will be for 10 days. Usual care: All participants will otherwise receive usual medical care	Placebo + Usual Care n=350 Participants The randomized intervention will a matching placebo, in combination with usual care. Placebo: The control intervention will be a placebo, for 10 days. Usual care: All participants will otherwise receive usual medical care
Primary Hierarchical Composite Endpoint	5.32 Ranked Severity Score Interval 2.98 to 6.0	5.33 Ranked Severity Score Interval 2.98 to 6.0

SECONDARY outcome

Timeframe: Up to 30 days

Number of days participants were alive, out of the intensive care unit, free of mechanical ventilation/extracorporeal membrane oxygenation, or maximal available respiratory support during the 30 days that followed randomization

Outcome measures

Outcome measures
Measure	Fenofibrate + Usual Care n=351 Participants The randomized intervention will be Fenofibrate, in combination with usual care. Dosing: 145 mg of Tricor or a dose-equivalent preparation Fenofibrate/fenofibric acid: The randomized intervention will be fenofibrate (Tricor) at a dose of 145 mg/d or dose-equivalent preparation of fenofibrate or fenofibric acid, for 10 days. In all cases, appropriate dose reductions will be implemented for patients with chronic kidney disease as per the approved preparation label. The intended duration of randomized treatment will be for 10 days. Usual care: All participants will otherwise receive usual medical care	Placebo + Usual Care n=350 Participants The randomized intervention will a matching placebo, in combination with usual care. Placebo: The control intervention will be a placebo, for 10 days. Usual care: All participants will otherwise receive usual medical care
Number of Days Alive, Out of the Intensive Care Unit, Free of Mechanical Ventilation/Extracorporeal Membrane Oxygenation, or Maximal Available Respiratory Support in the 30 Days Following Randomization	28.8 days Standard Deviation 4.9	28.3 days Standard Deviation 6.1

SECONDARY outcome

Timeframe: At 15 days

A seven-category ordinal scale consisting of the following categories: 1, not hospitalized with resumption of normal activities; 2, not hospitalized, but unable to resume normal activities; 3, hospitalized, not requiring supplemental oxygen; 4, hospitalized, requiring supplemental oxygen; 5, hospitalized, requiring nasal high-flow oxygen therapy, noninvasive mechanical ventilation, or both; 6, hospitalized, requiring extracorporeal membrane oxygenation (ECMO), invasive mechanical ventilation, or both; and 7, death.

Outcome measures

Outcome measures
Measure	Fenofibrate + Usual Care n=351 Participants The randomized intervention will be Fenofibrate, in combination with usual care. Dosing: 145 mg of Tricor or a dose-equivalent preparation Fenofibrate/fenofibric acid: The randomized intervention will be fenofibrate (Tricor) at a dose of 145 mg/d or dose-equivalent preparation of fenofibrate or fenofibric acid, for 10 days. In all cases, appropriate dose reductions will be implemented for patients with chronic kidney disease as per the approved preparation label. The intended duration of randomized treatment will be for 10 days. Usual care: All participants will otherwise receive usual medical care	Placebo + Usual Care n=350 Participants The randomized intervention will a matching placebo, in combination with usual care. Placebo: The control intervention will be a placebo, for 10 days. Usual care: All participants will otherwise receive usual medical care
Seven-category Ordinal Scale	1 score on a scale Interval 1.0 to 1.0	1 score on a scale Interval 1.0 to 2.0

SECONDARY outcome

Timeframe: Up to 30 days

The secondary global rank score, or global severity score, is a nonparametric, hierarchically ranked outcome. The global rank score was generated by ranking all 701 participants on a scale of 1 to 701, from worst to best clinical outcomes. Participants were ranked by (1) time to death; (2) the number of days supported by invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); (3) The inspired concentration of oxygen/percent oxygen saturation (FiO2/SpO2) ratio area under the curve; (4) For participants enrolled as outpatients who are subsequently hospitalized, the number of days out of the hospital during the 30 day-period following randomization; (5) For participants enrolled as outpatients who don't get hospitalized during the 30-day observation period, a COVID-19 symptom scale rating fever, cough, dyspnea, muscle aches, sore throat, loss of smell or taste, headache, diarrhea, fatigue, nausea/vomiting, chest pain (each are rated from 0-10 then summed).

Outcome measures

Outcome measures
Measure	Fenofibrate + Usual Care n=351 Participants The randomized intervention will be Fenofibrate, in combination with usual care. Dosing: 145 mg of Tricor or a dose-equivalent preparation Fenofibrate/fenofibric acid: The randomized intervention will be fenofibrate (Tricor) at a dose of 145 mg/d or dose-equivalent preparation of fenofibrate or fenofibric acid, for 10 days. In all cases, appropriate dose reductions will be implemented for patients with chronic kidney disease as per the approved preparation label. The intended duration of randomized treatment will be for 10 days. Usual care: All participants will otherwise receive usual medical care	Placebo + Usual Care n=350 Participants The randomized intervention will a matching placebo, in combination with usual care. Placebo: The control intervention will be a placebo, for 10 days. Usual care: All participants will otherwise receive usual medical care
Secondary Hierarchical Composite Endpoint	5.05 score on a scale Interval 2.98 to 5.22	5.05 score on a scale Interval 2.98 to 5.21

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 30 days

Death from any cause during the observation period

Outcome measures

Outcome measures
Measure	Fenofibrate + Usual Care n=351 Participants The randomized intervention will be Fenofibrate, in combination with usual care. Dosing: 145 mg of Tricor or a dose-equivalent preparation Fenofibrate/fenofibric acid: The randomized intervention will be fenofibrate (Tricor) at a dose of 145 mg/d or dose-equivalent preparation of fenofibrate or fenofibric acid, for 10 days. In all cases, appropriate dose reductions will be implemented for patients with chronic kidney disease as per the approved preparation label. The intended duration of randomized treatment will be for 10 days. Usual care: All participants will otherwise receive usual medical care	Placebo + Usual Care n=350 Participants The randomized intervention will a matching placebo, in combination with usual care. Placebo: The control intervention will be a placebo, for 10 days. Usual care: All participants will otherwise receive usual medical care
All-Cause Death	19 Participants	22 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 30 days

Number of days that participants were alive and out of the hospital during the 30 days following randomization

Outcome measures

Outcome measures
Measure	Fenofibrate + Usual Care n=351 Participants The randomized intervention will be Fenofibrate, in combination with usual care. Dosing: 145 mg of Tricor or a dose-equivalent preparation Fenofibrate/fenofibric acid: The randomized intervention will be fenofibrate (Tricor) at a dose of 145 mg/d or dose-equivalent preparation of fenofibrate or fenofibric acid, for 10 days. In all cases, appropriate dose reductions will be implemented for patients with chronic kidney disease as per the approved preparation label. The intended duration of randomized treatment will be for 10 days. Usual care: All participants will otherwise receive usual medical care	Placebo + Usual Care n=350 Participants The randomized intervention will a matching placebo, in combination with usual care. Placebo: The control intervention will be a placebo, for 10 days. Usual care: All participants will otherwise receive usual medical care
Number of Days Alive and Out of the Hospital During the 30 Days Following Randomization	30 days Interval 25.0 to 30.0	30 days Interval 25.0 to 30.0

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 30 days

The exploratory global rank score, or global severity score, is a nonparametric, hierarchically ranked outcome. The global rank score was generated by ranking all 701 participants on a scale of 1 to 701, from worst to best clinical outcomes. Participants were ranked by (1) time to death; (2) the number of days supported by invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); (3) The inspired concentration of oxygen/percent oxygen saturation (FiO2/SpO2) ratio area under the curve; (4) The number of days out of the hospital during the 30 day-period following randomization.

Outcome measures

Outcome measures
Measure	Fenofibrate + Usual Care n=351 Participants The randomized intervention will be Fenofibrate, in combination with usual care. Dosing: 145 mg of Tricor or a dose-equivalent preparation Fenofibrate/fenofibric acid: The randomized intervention will be fenofibrate (Tricor) at a dose of 145 mg/d or dose-equivalent preparation of fenofibrate or fenofibric acid, for 10 days. In all cases, appropriate dose reductions will be implemented for patients with chronic kidney disease as per the approved preparation label. The intended duration of randomized treatment will be for 10 days. Usual care: All participants will otherwise receive usual medical care	Placebo + Usual Care n=350 Participants The randomized intervention will a matching placebo, in combination with usual care. Placebo: The control intervention will be a placebo, for 10 days. Usual care: All participants will otherwise receive usual medical care
Exploratory Hierarchical Composite Endpoint	5.03 score on a scale Interval 2.98 to 5.03	5.03 score on a scale Interval 2.98 to 5.03

Adverse Events

Fenofibrate + Usual Care

Serious events: 46 serious events

Other events: 74 other events

Deaths: 19 deaths

Placebo + Usual Care

Serious events: 61 serious events

Other events: 55 other events

Deaths: 22 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Fenofibrate + Usual Care n=351 participants at risk The randomized intervention will be Fenofibrate, in combination with usual care. Dosing: 145 mg of Tricor or a dose-equivalent preparation Fenofibrate/fenofibric acid: The randomized intervention will be fenofibrate (Tricor) at a dose of 145 mg/d or dose-equivalent preparation of fenofibrate or fenofibric acid, for 10 days. In all cases, appropriate dose reductions will be implemented for patients with chronic kidney disease as per the approved preparation label. The intended duration of randomized treatment will be for 10 days. Usual care: All participants will otherwise receive usual medical care	Placebo + Usual Care n=350 participants at risk The randomized intervention will a matching placebo, in combination with usual care. Placebo: The control intervention will be a placebo, for 10 days. Usual care: All participants will otherwise receive usual medical care
Renal and urinary disorders Kidney	2.3% 8/351 • Number of events 11 • 30 days post-randomization The research team kept a log of all adverse events in the trial. A medically-qualified investigator assessed all AEs, which were classified by organ system category. The definition of adverse events and Serious Adverse Events (SAE) is presented in detail in the study protocol, available in this clinicaltrials.gov record (protocol sections 4.1, 4.2 and 4.3)	2.9% 10/350 • Number of events 19 • 30 days post-randomization The research team kept a log of all adverse events in the trial. A medically-qualified investigator assessed all AEs, which were classified by organ system category. The definition of adverse events and Serious Adverse Events (SAE) is presented in detail in the study protocol, available in this clinicaltrials.gov record (protocol sections 4.1, 4.2 and 4.3)
Hepatobiliary disorders Hepatic	5.7% 20/351 • Number of events 25 • 30 days post-randomization The research team kept a log of all adverse events in the trial. A medically-qualified investigator assessed all AEs, which were classified by organ system category. The definition of adverse events and Serious Adverse Events (SAE) is presented in detail in the study protocol, available in this clinicaltrials.gov record (protocol sections 4.1, 4.2 and 4.3)	4.6% 16/350 • Number of events 24 • 30 days post-randomization The research team kept a log of all adverse events in the trial. A medically-qualified investigator assessed all AEs, which were classified by organ system category. The definition of adverse events and Serious Adverse Events (SAE) is presented in detail in the study protocol, available in this clinicaltrials.gov record (protocol sections 4.1, 4.2 and 4.3)
Cardiac disorders Cardiovascular	2.3% 8/351 • Number of events 8 • 30 days post-randomization The research team kept a log of all adverse events in the trial. A medically-qualified investigator assessed all AEs, which were classified by organ system category. The definition of adverse events and Serious Adverse Events (SAE) is presented in detail in the study protocol, available in this clinicaltrials.gov record (protocol sections 4.1, 4.2 and 4.3)	2.3% 8/350 • Number of events 10 • 30 days post-randomization The research team kept a log of all adverse events in the trial. A medically-qualified investigator assessed all AEs, which were classified by organ system category. The definition of adverse events and Serious Adverse Events (SAE) is presented in detail in the study protocol, available in this clinicaltrials.gov record (protocol sections 4.1, 4.2 and 4.3)
Respiratory, thoracic and mediastinal disorders Respiratory	1.7% 6/351 • Number of events 7 • 30 days post-randomization The research team kept a log of all adverse events in the trial. A medically-qualified investigator assessed all AEs, which were classified by organ system category. The definition of adverse events and Serious Adverse Events (SAE) is presented in detail in the study protocol, available in this clinicaltrials.gov record (protocol sections 4.1, 4.2 and 4.3)	1.4% 5/350 • Number of events 10 • 30 days post-randomization The research team kept a log of all adverse events in the trial. A medically-qualified investigator assessed all AEs, which were classified by organ system category. The definition of adverse events and Serious Adverse Events (SAE) is presented in detail in the study protocol, available in this clinicaltrials.gov record (protocol sections 4.1, 4.2 and 4.3)
Gastrointestinal disorders Gastroenterologic	4.6% 16/351 • Number of events 17 • 30 days post-randomization The research team kept a log of all adverse events in the trial. A medically-qualified investigator assessed all AEs, which were classified by organ system category. The definition of adverse events and Serious Adverse Events (SAE) is presented in detail in the study protocol, available in this clinicaltrials.gov record (protocol sections 4.1, 4.2 and 4.3)	1.4% 5/350 • Number of events 5 • 30 days post-randomization The research team kept a log of all adverse events in the trial. A medically-qualified investigator assessed all AEs, which were classified by organ system category. The definition of adverse events and Serious Adverse Events (SAE) is presented in detail in the study protocol, available in this clinicaltrials.gov record (protocol sections 4.1, 4.2 and 4.3)
Infections and infestations Infectious	6.8% 24/351 • Number of events 45 • 30 days post-randomization The research team kept a log of all adverse events in the trial. A medically-qualified investigator assessed all AEs, which were classified by organ system category. The definition of adverse events and Serious Adverse Events (SAE) is presented in detail in the study protocol, available in this clinicaltrials.gov record (protocol sections 4.1, 4.2 and 4.3)	6.0% 21/350 • Number of events 30 • 30 days post-randomization The research team kept a log of all adverse events in the trial. A medically-qualified investigator assessed all AEs, which were classified by organ system category. The definition of adverse events and Serious Adverse Events (SAE) is presented in detail in the study protocol, available in this clinicaltrials.gov record (protocol sections 4.1, 4.2 and 4.3)
Nervous system disorders Neurologic	0.85% 3/351 • Number of events 5 • 30 days post-randomization The research team kept a log of all adverse events in the trial. A medically-qualified investigator assessed all AEs, which were classified by organ system category. The definition of adverse events and Serious Adverse Events (SAE) is presented in detail in the study protocol, available in this clinicaltrials.gov record (protocol sections 4.1, 4.2 and 4.3)	0.86% 3/350 • Number of events 3 • 30 days post-randomization The research team kept a log of all adverse events in the trial. A medically-qualified investigator assessed all AEs, which were classified by organ system category. The definition of adverse events and Serious Adverse Events (SAE) is presented in detail in the study protocol, available in this clinicaltrials.gov record (protocol sections 4.1, 4.2 and 4.3)
Skin and subcutaneous tissue disorders Dermatologic	0.57% 2/351 • Number of events 2 • 30 days post-randomization The research team kept a log of all adverse events in the trial. A medically-qualified investigator assessed all AEs, which were classified by organ system category. The definition of adverse events and Serious Adverse Events (SAE) is presented in detail in the study protocol, available in this clinicaltrials.gov record (protocol sections 4.1, 4.2 and 4.3)	0.29% 1/350 • Number of events 1 • 30 days post-randomization The research team kept a log of all adverse events in the trial. A medically-qualified investigator assessed all AEs, which were classified by organ system category. The definition of adverse events and Serious Adverse Events (SAE) is presented in detail in the study protocol, available in this clinicaltrials.gov record (protocol sections 4.1, 4.2 and 4.3)
Endocrine disorders Endocrinologic	0.28% 1/351 • Number of events 1 • 30 days post-randomization The research team kept a log of all adverse events in the trial. A medically-qualified investigator assessed all AEs, which were classified by organ system category. The definition of adverse events and Serious Adverse Events (SAE) is presented in detail in the study protocol, available in this clinicaltrials.gov record (protocol sections 4.1, 4.2 and 4.3)	0.57% 2/350 • Number of events 2 • 30 days post-randomization The research team kept a log of all adverse events in the trial. A medically-qualified investigator assessed all AEs, which were classified by organ system category. The definition of adverse events and Serious Adverse Events (SAE) is presented in detail in the study protocol, available in this clinicaltrials.gov record (protocol sections 4.1, 4.2 and 4.3)
Blood and lymphatic system disorders Hematologic	2.6% 9/351 • Number of events 12 • 30 days post-randomization The research team kept a log of all adverse events in the trial. A medically-qualified investigator assessed all AEs, which were classified by organ system category. The definition of adverse events and Serious Adverse Events (SAE) is presented in detail in the study protocol, available in this clinicaltrials.gov record (protocol sections 4.1, 4.2 and 4.3)	2.9% 10/350 • Number of events 13 • 30 days post-randomization The research team kept a log of all adverse events in the trial. A medically-qualified investigator assessed all AEs, which were classified by organ system category. The definition of adverse events and Serious Adverse Events (SAE) is presented in detail in the study protocol, available in this clinicaltrials.gov record (protocol sections 4.1, 4.2 and 4.3)
Musculoskeletal and connective tissue disorders Musculoskeletal	1.1% 4/351 • Number of events 4 • 30 days post-randomization The research team kept a log of all adverse events in the trial. A medically-qualified investigator assessed all AEs, which were classified by organ system category. The definition of adverse events and Serious Adverse Events (SAE) is presented in detail in the study protocol, available in this clinicaltrials.gov record (protocol sections 4.1, 4.2 and 4.3)	0.57% 2/350 • Number of events 2 • 30 days post-randomization The research team kept a log of all adverse events in the trial. A medically-qualified investigator assessed all AEs, which were classified by organ system category. The definition of adverse events and Serious Adverse Events (SAE) is presented in detail in the study protocol, available in this clinicaltrials.gov record (protocol sections 4.1, 4.2 and 4.3)
General disorders Other	0.57% 2/351 • Number of events 2 • 30 days post-randomization The research team kept a log of all adverse events in the trial. A medically-qualified investigator assessed all AEs, which were classified by organ system category. The definition of adverse events and Serious Adverse Events (SAE) is presented in detail in the study protocol, available in this clinicaltrials.gov record (protocol sections 4.1, 4.2 and 4.3)	0.57% 2/350 • Number of events 2 • 30 days post-randomization The research team kept a log of all adverse events in the trial. A medically-qualified investigator assessed all AEs, which were classified by organ system category. The definition of adverse events and Serious Adverse Events (SAE) is presented in detail in the study protocol, available in this clinicaltrials.gov record (protocol sections 4.1, 4.2 and 4.3)

Additional Information

Katherine Greene

University of Pennsylvania

Phone: 215-662-7580

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Fenofibrate + Usual Care n=351 participants at risk The randomized intervention will be Fenofibrate, in combination with usual care. Dosing: 145 mg of Tricor or a dose-equivalent preparation Fenofibrate/fenofibric acid: The randomized intervention will be fenofibrate (Tricor) at a dose of 145 mg/d or dose-equivalent preparation of fenofibrate or fenofibric acid, for 10 days. In all cases, appropriate dose reductions will be implemented for patients with chronic kidney disease as per the approved preparation label. The intended duration of randomized treatment will be for 10 days. Usual care: All participants will otherwise receive usual medical care	Placebo + Usual Care n=350 participants at risk The randomized intervention will a matching placebo, in combination with usual care. Placebo: The control intervention will be a placebo, for 10 days. Usual care: All participants will otherwise receive usual medical care
General disorders Intensive Care Unit Transfer	3.7% 13/351 • Number of events 13 • 30 days post-randomization The research team kept a log of all adverse events in the trial. A medically-qualified investigator assessed all AEs, which were classified by organ system category. The definition of adverse events and Serious Adverse Events (SAE) is presented in detail in the study protocol, available in this clinicaltrials.gov record (protocol sections 4.1, 4.2 and 4.3)	4.6% 16/350 • Number of events 17 • 30 days post-randomization The research team kept a log of all adverse events in the trial. A medically-qualified investigator assessed all AEs, which were classified by organ system category. The definition of adverse events and Serious Adverse Events (SAE) is presented in detail in the study protocol, available in this clinicaltrials.gov record (protocol sections 4.1, 4.2 and 4.3)
General disorders Death	5.4% 19/351 • Number of events 19 • 30 days post-randomization The research team kept a log of all adverse events in the trial. A medically-qualified investigator assessed all AEs, which were classified by organ system category. The definition of adverse events and Serious Adverse Events (SAE) is presented in detail in the study protocol, available in this clinicaltrials.gov record (protocol sections 4.1, 4.2 and 4.3)	6.3% 22/350 • Number of events 22 • 30 days post-randomization The research team kept a log of all adverse events in the trial. A medically-qualified investigator assessed all AEs, which were classified by organ system category. The definition of adverse events and Serious Adverse Events (SAE) is presented in detail in the study protocol, available in this clinicaltrials.gov record (protocol sections 4.1, 4.2 and 4.3)
Respiratory, thoracic and mediastinal disorders Invasive mechanical ventilation	4.0% 14/351 • Number of events 15 • 30 days post-randomization The research team kept a log of all adverse events in the trial. A medically-qualified investigator assessed all AEs, which were classified by organ system category. The definition of adverse events and Serious Adverse Events (SAE) is presented in detail in the study protocol, available in this clinicaltrials.gov record (protocol sections 4.1, 4.2 and 4.3)	4.6% 16/350 • Number of events 16 • 30 days post-randomization The research team kept a log of all adverse events in the trial. A medically-qualified investigator assessed all AEs, which were classified by organ system category. The definition of adverse events and Serious Adverse Events (SAE) is presented in detail in the study protocol, available in this clinicaltrials.gov record (protocol sections 4.1, 4.2 and 4.3)
Cardiac disorders Acute Coronary Syndrome	2.6% 9/351 • Number of events 10 • 30 days post-randomization The research team kept a log of all adverse events in the trial. A medically-qualified investigator assessed all AEs, which were classified by organ system category. The definition of adverse events and Serious Adverse Events (SAE) is presented in detail in the study protocol, available in this clinicaltrials.gov record (protocol sections 4.1, 4.2 and 4.3)	0.29% 1/350 • Number of events 1 • 30 days post-randomization The research team kept a log of all adverse events in the trial. A medically-qualified investigator assessed all AEs, which were classified by organ system category. The definition of adverse events and Serious Adverse Events (SAE) is presented in detail in the study protocol, available in this clinicaltrials.gov record (protocol sections 4.1, 4.2 and 4.3)
Cardiac disorders Myocarditis	0.28% 1/351 • Number of events 1 • 30 days post-randomization The research team kept a log of all adverse events in the trial. A medically-qualified investigator assessed all AEs, which were classified by organ system category. The definition of adverse events and Serious Adverse Events (SAE) is presented in detail in the study protocol, available in this clinicaltrials.gov record (protocol sections 4.1, 4.2 and 4.3)	0.86% 3/350 • Number of events 3 • 30 days post-randomization The research team kept a log of all adverse events in the trial. A medically-qualified investigator assessed all AEs, which were classified by organ system category. The definition of adverse events and Serious Adverse Events (SAE) is presented in detail in the study protocol, available in this clinicaltrials.gov record (protocol sections 4.1, 4.2 and 4.3)
Vascular disorders Thrombosis	0.57% 2/351 • Number of events 2 • 30 days post-randomization The research team kept a log of all adverse events in the trial. A medically-qualified investigator assessed all AEs, which were classified by organ system category. The definition of adverse events and Serious Adverse Events (SAE) is presented in detail in the study protocol, available in this clinicaltrials.gov record (protocol sections 4.1, 4.2 and 4.3)	0.00% 0/350 • 30 days post-randomization The research team kept a log of all adverse events in the trial. A medically-qualified investigator assessed all AEs, which were classified by organ system category. The definition of adverse events and Serious Adverse Events (SAE) is presented in detail in the study protocol, available in this clinicaltrials.gov record (protocol sections 4.1, 4.2 and 4.3)
Psychiatric disorders New or worsening cognitive status	1.4% 5/351 • Number of events 5 • 30 days post-randomization The research team kept a log of all adverse events in the trial. A medically-qualified investigator assessed all AEs, which were classified by organ system category. The definition of adverse events and Serious Adverse Events (SAE) is presented in detail in the study protocol, available in this clinicaltrials.gov record (protocol sections 4.1, 4.2 and 4.3)	0.57% 2/350 • Number of events 2 • 30 days post-randomization The research team kept a log of all adverse events in the trial. A medically-qualified investigator assessed all AEs, which were classified by organ system category. The definition of adverse events and Serious Adverse Events (SAE) is presented in detail in the study protocol, available in this clinicaltrials.gov record (protocol sections 4.1, 4.2 and 4.3)
Hepatobiliary disorders Liver failure or acute liver injury	0.57% 2/351 • Number of events 2 • 30 days post-randomization The research team kept a log of all adverse events in the trial. A medically-qualified investigator assessed all AEs, which were classified by organ system category. The definition of adverse events and Serious Adverse Events (SAE) is presented in detail in the study protocol, available in this clinicaltrials.gov record (protocol sections 4.1, 4.2 and 4.3)	2.6% 9/350 • Number of events 11 • 30 days post-randomization The research team kept a log of all adverse events in the trial. A medically-qualified investigator assessed all AEs, which were classified by organ system category. The definition of adverse events and Serious Adverse Events (SAE) is presented in detail in the study protocol, available in this clinicaltrials.gov record (protocol sections 4.1, 4.2 and 4.3)
Renal and urinary disorders Acute kidney injury	2.0% 7/351 • Number of events 16 • 30 days post-randomization The research team kept a log of all adverse events in the trial. A medically-qualified investigator assessed all AEs, which were classified by organ system category. The definition of adverse events and Serious Adverse Events (SAE) is presented in detail in the study protocol, available in this clinicaltrials.gov record (protocol sections 4.1, 4.2 and 4.3)	3.4% 12/350 • Number of events 14 • 30 days post-randomization The research team kept a log of all adverse events in the trial. A medically-qualified investigator assessed all AEs, which were classified by organ system category. The definition of adverse events and Serious Adverse Events (SAE) is presented in detail in the study protocol, available in this clinicaltrials.gov record (protocol sections 4.1, 4.2 and 4.3)
Musculoskeletal and connective tissue disorders Suspected or confirmed rhabdomyolysis	0.00% 0/351 • 30 days post-randomization The research team kept a log of all adverse events in the trial. A medically-qualified investigator assessed all AEs, which were classified by organ system category. The definition of adverse events and Serious Adverse Events (SAE) is presented in detail in the study protocol, available in this clinicaltrials.gov record (protocol sections 4.1, 4.2 and 4.3)	0.29% 1/350 • Number of events 1 • 30 days post-randomization The research team kept a log of all adverse events in the trial. A medically-qualified investigator assessed all AEs, which were classified by organ system category. The definition of adverse events and Serious Adverse Events (SAE) is presented in detail in the study protocol, available in this clinicaltrials.gov record (protocol sections 4.1, 4.2 and 4.3)
Respiratory, thoracic and mediastinal disorders Worsening dyspnea or hypoxia	6.6% 23/351 • Number of events 23 • 30 days post-randomization The research team kept a log of all adverse events in the trial. A medically-qualified investigator assessed all AEs, which were classified by organ system category. The definition of adverse events and Serious Adverse Events (SAE) is presented in detail in the study protocol, available in this clinicaltrials.gov record (protocol sections 4.1, 4.2 and 4.3)	8.9% 31/350 • Number of events 32 • 30 days post-randomization The research team kept a log of all adverse events in the trial. A medically-qualified investigator assessed all AEs, which were classified by organ system category. The definition of adverse events and Serious Adverse Events (SAE) is presented in detail in the study protocol, available in this clinicaltrials.gov record (protocol sections 4.1, 4.2 and 4.3)
Infections and infestations Superimposed infection	2.0% 7/351 • Number of events 8 • 30 days post-randomization The research team kept a log of all adverse events in the trial. A medically-qualified investigator assessed all AEs, which were classified by organ system category. The definition of adverse events and Serious Adverse Events (SAE) is presented in detail in the study protocol, available in this clinicaltrials.gov record (protocol sections 4.1, 4.2 and 4.3)	1.1% 4/350 • Number of events 4 • 30 days post-randomization The research team kept a log of all adverse events in the trial. A medically-qualified investigator assessed all AEs, which were classified by organ system category. The definition of adverse events and Serious Adverse Events (SAE) is presented in detail in the study protocol, available in this clinicaltrials.gov record (protocol sections 4.1, 4.2 and 4.3)
Gastrointestinal disorders New or worsening diarrhea, nausea, or vomiting	0.28% 1/351 • Number of events 1 • 30 days post-randomization The research team kept a log of all adverse events in the trial. A medically-qualified investigator assessed all AEs, which were classified by organ system category. The definition of adverse events and Serious Adverse Events (SAE) is presented in detail in the study protocol, available in this clinicaltrials.gov record (protocol sections 4.1, 4.2 and 4.3)	0.86% 3/350 • Number of events 3 • 30 days post-randomization The research team kept a log of all adverse events in the trial. A medically-qualified investigator assessed all AEs, which were classified by organ system category. The definition of adverse events and Serious Adverse Events (SAE) is presented in detail in the study protocol, available in this clinicaltrials.gov record (protocol sections 4.1, 4.2 and 4.3)
Nervous system disorders Other new or worsening neurologic issues	0.57% 2/351 • Number of events 2 • 30 days post-randomization The research team kept a log of all adverse events in the trial. A medically-qualified investigator assessed all AEs, which were classified by organ system category. The definition of adverse events and Serious Adverse Events (SAE) is presented in detail in the study protocol, available in this clinicaltrials.gov record (protocol sections 4.1, 4.2 and 4.3)	0.57% 2/350 • Number of events 2 • 30 days post-randomization The research team kept a log of all adverse events in the trial. A medically-qualified investigator assessed all AEs, which were classified by organ system category. The definition of adverse events and Serious Adverse Events (SAE) is presented in detail in the study protocol, available in this clinicaltrials.gov record (protocol sections 4.1, 4.2 and 4.3)
General disorders Other	3.1% 11/351 • Number of events 18 • 30 days post-randomization The research team kept a log of all adverse events in the trial. A medically-qualified investigator assessed all AEs, which were classified by organ system category. The definition of adverse events and Serious Adverse Events (SAE) is presented in detail in the study protocol, available in this clinicaltrials.gov record (protocol sections 4.1, 4.2 and 4.3)	4.6% 16/350 • Number of events 21 • 30 days post-randomization The research team kept a log of all adverse events in the trial. A medically-qualified investigator assessed all AEs, which were classified by organ system category. The definition of adverse events and Serious Adverse Events (SAE) is presented in detail in the study protocol, available in this clinicaltrials.gov record (protocol sections 4.1, 4.2 and 4.3)