Improved Survival Confirmed in Highly Comorbid COVID-19 Patients
Pennsylvania-based NRx Pharmaceuticals today announced top-line data demonstrating improved outcomes at one year in highly comorbid COVID-19 patients who were treated with ZYESAMI™.
ZYESAMI (aviptadil) is a synthetic form of Vasoactive Intestinal Polypeptide.
Between June and September 2020, a trial was conducted at a leading tertiary care hospital involving patients whose level of comorbidity excluded them from the randomized phase 2b/3 clinical trial of ZYESAMI.
Participants in this trial have now been followed for one year from initial enrollment.
The top-line results show a statistically significant (P<.0001) 3-fold advantage in the likelihood of being alive at one year post-treatment (60% vs. 20%) among those treated with ZYESAMI, in addition to standard of care.
Assignment to ZYESAMI in the trial was based on the specific medical team which admitted the patient to the intensive care unit (ICU). Once in the ICU, all patients were cared for by the same medical team, and according to the same treatment protocols.
"These latest data are encouraging and will help those of us on the frontlines treat the sickest COVID patients, potentially providing new treatment options and strategies," commented Dr. J. Georges Youssef, the Principal Investigator who serves as Head of Academic Pulmonary Medicine at Houston Methodist Hospital and as Assistant Professor of Clinical Medicine at Weill Cornell Medical College, in a press release.
These one-year findings are consistent with the increased odds of 60-day survival seen in the previously reported results from the phase 2b/3 randomized controlled trial of ZYESAMI.
ZYESAMI Remains Under Review by the U.S. FDA for Emergency Use Authorization in Patients Suffering Critical Covid-19 with Respiratory Failure.
NRx Pharmaceuticals draws upon more than 300 years of collective, scientific, and drug-development experience to bring improved health to patients. NRx also has the BriLife™ vaccine for COVID-19 in clinical trials and holds the exclusive worldwide license to commercialize the vaccine.