Design and participants
pneumonia, multiple organ dysfunction, kidney disease, chronic kidney disease stage, hypersensitivity
PNEUMONIA, KIDNEY DISEASE, RESPIRATORY FAILURE, DISEASE, CHRONIC KIDNEY DISEASE STAGE 1, INFILTRATES, SEPTIC SHOCK, DISEASE, HYPERSENSITIVITY
The study was conducted as an open-label, phase 3 a clinical trial, in the Barzilai Medical Center, Ashkelon, Israel. The study was approved by the Barzilai Medical Center Research Ethics Committee (0105–20-BRZ). The study enrolled adults (≥18 years of age) with severe Covid-19 pneumonia, as confirmed by positive polymerase-chain-reaction (PCR) and evidenced by bilateral chest infiltrates on chest radiography or computed tomography. Eligible patients had a disease severity score of 4 (Hospitalized, requiring supplemental oxygen), increased oxygen requirement compared to baseline at home, a blood oxygen saturation of 93% or less on room air, or 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, and lung infiltrates >50% on chest CT within 72 hr of hospital admission or within 72 hr of a positive test result.Individuals who had respiratory failure, septic shock, and/or multiple organ dysfunction, SOFA ≥ 5 or Disease Severity Score ≤ 3 (requiring noninvasive mechanical ventilation, requiring extracorporeal membrane oxygenation (ECMO), invasive mechanical ventilation, or all) were excluded. Additionally, individuals with known hypersensitivity to fenofibrate, patient-reported history, or electronic medical record history of severe kidney disease (defined as any history of dialysis, history of chronic kidney disease stage IV or estimated Glomerular Filtration Rate (eGFR) of <30 ml/min/1.73 mAll participants provided written informed consent signed by the participant or legally authorized representative. Standard care according to local practice (supplemental oxygen, antiviral treatment, anticoagulants, vitamin D3, low-dose glucocorticoids, convalescent plasma and supportive care) was provided. However, concomitant treatment with another investigational agent (except antiviral drugs) or any immunomodulatory agent, was prohibited. Written informed consent was obtained from all the patients or, if written consent could not be provided, the patient’s legally authorized representative could provide oral consent with appropriate documentation by the investigator. The primary analysis was performed on day 14, a follow-up was done 28 days post-admission.