The single-centre and randomised clinical study will evaluate the efficacy of CPAP therapy in 200 COVID-19 confirmed or suspected patients
Itamar Medical has announces the initiation of funded trial to assess CPAP therapy in COVID-19 patients. (Credit: Thiago Lazarino from Pixabay)
Medical technology company Itamar Medical has funded the clinical study designed to assess the potential impact of continuous positive airway pressure (CPAP) therapy in the patients with COVID-19 disease.
The prospective, single-centre, parallel-group, open-label and randomised clinical study will evaluate the efficacy of CPAP in 200 COVID-19 confirmed or suspected patients within the Mount Sinai Health System with respiratory symptoms who do need hospital admission and discharged home from the emergency room.
The study has been designed to show the benefit of CPAP therapy in delaying or eliminating hospitalisation in COVID-19 patients
The primary intention of the trial is to determine whether the early, low and fixed CPAP at home holds the capacity to reduce the risk of hospital/ER re-admission or death in COVID-19 confirmed or suspected patients.
Secondary aims of the trial are to determine whether obstructive sleep apnea (OSA) and obesity are independently linked with increased hospitalisations, mechanical ventilation, and death in COVID-19 suspected or infected patients.
Itamar’s trial will also record COVID-19 conversion rates for household members of participants randomised to CPAP against control.
The patients will also be provided with a disposable WatchPAT ONE connected to the Itamar Medical Digital Health platform. It will be activated via the smartphone application to determine their sleep apnea status.
Itamar will randomise the subjects to secure 72 hours of CPAP or to a control group. According to the company, the trial’s primary endpoint is time to hospital admission or death within 14 days of randomisation.
Itamar Medical global medical director Dr Jennifer Cook said: “We are very pleased to be working with Dr. Shah and the team, including Drs. Indu Ayappa, David Rapoport and Ms. Samira Khan at Mount Sinai, to evaluate the potential use of CPAP to improve patient management and outcomes while reducing stress on the healthcare system.
“Additionally, understanding the extent to which OSA may be a risk factor for adverse COVID-19-related outcomes will help to inform proactive risk-mitigation strategies. I would also like to thank Philips for donating their high-quality CPAPs for this study.”
In June 2019, Itamar Medical secured 510(k) clearance from the US Food and Drug Administration (FDA) for its WatchPAT One fully disposable home sleep apnea test (HSAT).