The INTEGRIS-ARDS clinical trial is studying PLN-74809, an oral investigational medicine designed to treat lung fibrosis (when tissue becomes damaged and scarred, affecting normal function of the organ). The purpose of this study is to assess the safety and tolerability of PLN-74809 in patients with acute respiratory distress syndrome (ARDS) associated with severe COVID-19.
What to expect in the INTEGRIS-ARDS clinical trial
The study will consist of:
- A screening period, up to three days
- A treatment period, up to two weeks, during which, you will be hospitalized
- If you are able to leave the hospital earlier than two weeks, you will have completed your in-person visits
- A follow-up period, which will consist of two phone calls (Day 28 and Day 90)
What is ARDS?
Acute Respiratory Distress Syndrome (ARDS) is a serious and potentially fatal condition caused by an injury to the lungs, often from infection or trauma. ARDS causes fluid to build up in the lungs, affecting their ability to get oxygen to the rest of the bloodstream — ultimately preventing vital organs from receiving the oxygen necessary to function properly. ARDS is a major cause of death in patients infected with COVID-19.
Can I participate?
Talk to your doctor about participating in this clinical trial if:
- You are a hospitalized patient confirmed ARDS diagnosis associated with at least severe COVID-19
- The trial is open to women and men
- The trial will include 10 study sites across the U.S. and the rest of the world
We are committed to protecting patients and clinicians from the spread of COVID-19. Our clinical trial sites are following all government and institutional safety guidelines.
Additionally, we are minimizing participants’ visits to trial sites by offering home-health solutions – with some tests and measures conducted through telehealth appointments in participant homes.
Pliant Therapeutics will continue to work closely with site investigators and update our practices accordingly to ensure the safe continuation of the trial.