COVID-19 trials registries data warehouse

https://www.ins.gob.pe/ensayosclinicos/rpec/recuperarECPBNuevoEN.asp?numec=099-20

Jenny Marilu Perez

jenny_murpe@hotmail.com

2020-12-30

Recruiting

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

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

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.

2

UNIVERSIDAD CATOLICA DE SANTA MARIA;

18

100

Argentina;Colombia;Mexico;Peru;United States

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

150

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.

Phase 2

[{"arm_notes": "", "treatment_id": 507, "treatment_name": "Fenofibrate", "treatment_type": "Metabolic agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]