None listed
Conditions
Interventions
Fenofibrate arm. Type of group
The randomized intervention will be fenofibrate at a dose of 160 mg/d, administered for 10 days.
Group name:Placebo arm Type of group
The intervention will be a placebo of appearance similar to the active drug
Sponsors
UNIVERSIDAD CATOLICA DE SANTA MARIA,
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age 18 years or older. 2. Diagnosis of COVID-19 (of any severity), based on: (a) A clinical presentation consistent with a positive laboratory test for SARS-CoV-2 (serological test or PCR); or (b) Considered by the family medical team as a person under investigation who is undergoing laboratory tests for COVID-19, with high clinical probability, in addition to compatible pulmonary infiltrates in radiographic plaque or chest tomography (bilateral, interstitial or ground glass opacities). Inclusion will require meeting criterion (2a) only, criterion (2b) only, or both. Patients who do not have a typical acute symptomatic picture of COVID-19 should not be included. 3. Ability to give informed consent. 4. Less than 14
Exclusion criteria
Exclusion criteria: 1. Known pregnancy or lactation. 2. Estimated glomerular filtration rate (eGFR) 60 mL/min/1.73m2 or on dialysis (chronic renal disease stage 3-5). 3. History of active liver disease, cholelithiasis, hypothyroidism or rhabdomyolysis (suspected or confirmed). For purposes of the study, any history of chronic hepatopathy (including chronic hepatitis of any etiology, liver cirrhosis), recent history (last 12 months) of acute hepatitis of any etiology shall be considered as active liver disease, or in the context of COVID-19, increase in circulating AST or ALT >3 times the upper normal limit (to be performed on all patients at trial cost, unless already available in the patient within the last 72 hours). Fatty liver without hepatitis, or a remote history (>12 months) of acute viral (e.g., hepatitis A) or medication-induced hepatitis that has not progressed to chronic liver disease, do not constitute an exclusion criterion for the study. 4. Known hypersensitivity to fenofibrate or fenofibric acid. 5. Current treatment with fenofibrate, clofibrate, warfarin or other coumarinic anticoagulants, glimepiride, cyclosporine, tacrolimus. 6. Use of statins, except simvastatin or atorvastatin. For these 2 statins, patients taking doses >40 mg/day will be excluded. 8. Inability to read, write, or lack of access to a phone. 9. Patients with endotracheal intubation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Blinded adjudication by the investigators based on systematic data collection regarding the clinical course of study participants. Measure:Primary endpoint: global rank score that ranks patient outcomes according to 5 factors: (1) time to death (ranked from lower to higher, up to 30 days post-randomization), (2) the number of days in mechanical ventilatory support (invasive or non-invasive) or extracorporeal membrane oxygenation (up to discharge, evaluated up to 30 days post-randomization, ranked from highest to lowest); (3) The area under the curve in the ratio inspired oxygen fraction/oxygen saturation percentage (FiO2/SpO2, up to discharge, evaluated up to 30 days post-randomization, ranked from highest to lowest); (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 (ranked from lowest to highest. Timepoints:30 days. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Blinded adjudication by the investigators based on systematic data collection regarding the clinical course of study participants Measure:Number of days alive, out of the intensive care unit, free of mechanical ventilation (invasive and non-invasive), extracorporeal membrane oxygenation (ECMO) or maximal available respiratory support in the 30 days following randomization. Timepoints:30 days. ; Outcome name:Blinded adjudication by the investigators based on systematic data collection regarding the clinical course of study participants Measure: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. Timepoints:30 days. ; Outcome name:Blinded adjudication by the investigators based on systematic data collection regarding the clinical course of study participants Measure:A global rank score similar to the primary endpoint, but using a more comprehensive COVID-19 symptom scale instead of the dyspnea Borg scale. Timepoints:30 days | — |
Countries
Argentina, Colombia, Mexico, Peru, United States
Contacts
Public ContactJenny Marilu Perez
UNIVERSIDAD CATOLICA DE SANTA MARIA
Outcome results
None listed