Piedmont Healthcare will participate in two new clinical trials that will investigate therapies for patients who are positive for COVID-19: one that will evaluate the efficacy of the anti-inflammatory drug Gimsilumab and another that will investigate proning, or repositioning patients to improve their oxygen levels. These studies began enrolling patients in early May.
The studies are officially named “A Study to Assess the Efficacy and Safety of Gimsilumab in Subjects With Lung Injury or Acute Respiratory Distress Syndrome Secondary to COVID-19,” or BREATHE, and “Awake Prone Positioning for Early hypoxemia in COVID-19” or APPEX-19.
“Piedmont’s mission is to serve its patients and by offering clinical trials designed to fight COVID-19 during this pandemic, we are delivering on our promise,” said Charles L. Brown, III, M.D., CEO of Piedmont Healthcare’s Physician Enterprise.
Amy Hajari Case, M.D., is Piedmont’s Medical Director of Pulmonary and Critical Care Research and principal site investigator for these trials.
“These clinical trial options, with the experimental therapies they bring to our patient populations, are exciting in that they look at fighting the disease from such different perspectives,” she said.
COVID-19 has two phases: an initial viral phase and then an inflammatory phase, which has been detected in major organs throughout the body. Gimsilumab is designed to target this reaction, to block parts of the body’s inflammatory cascade and to cool down the immune system’s response.
The trial will consist of 270 participants and is expected to be complete in October. Piedmont is one of 18 sites participating in this study and is the third to be activated.
As part of the inflammatory response, one of the symptoms that some COVID-19 patients report is difficulty breathing. The disease can diminish a patient’s oxygen levels to a dangerous degree. To investigate a potential therapy to address this issue, the APPEX-19 trial will study whether having COVID-19 patients who have mild symptoms lay prone on their stomachs soon after arriving at the hospital can improve their oxygen levels.
This therapy has been shown to be helpful in patients who suffer from Acute Respiratory Distress Syndrome (ARDS). Piedmont is one of 16 sites across the globe that is participating in this study, which is enrolling 200 participants and expects to be complete in May 2021.