A drug tested at Inova Health System has shown to improve clinical outcomes in hospitalized COVID-19 patients who required supplemental oxygen.
The Phase 2 clinical trial evaluating the safety of fostamatinib was conducted on behalf of Rigel Pharmaceuticals Inc., based in San Francisco. The study was sponsored by the National Heart, Lung, and Blood Institute, part of the National Institutes of Health, and results were published Wednesday in Clinical Infectious Diseases, an official publication of the Infectious Disease Society of America.
The study found that fostamatinib, in combination with the standard of care, was shown to be well tolerated and that patients treated with fostamatinib had less severe adverse events and improved clinical outcomes, compared with those who received a placebo, said Dr. Richard Childs, clinical director of the National Heart, Lung, and Blood Institute.
“As cases of COVID continue to surge across the world, improved therapies for patients hospitalized with COVID-19 are urgently needed,” Childs added.
The results from the 59-patient Phase 2 trial at Inova demonstrated that the addition of fostamatinib to the antiviral drug remdesivir and the steroid dexamethasone, was associated with clinically meaningful improvement in clinical outcomes in hospitalized COVID-19 patients who required supplemental oxygen, the health system said in a news release.
The study was not designed to test clinical efficacy, but patients who took the drug had lower mortality rates, less time to sustained recovery, fewer days on oxygen, and fewer days in the ICU, compared with those treated with a placebo.
“It’s reassuring to see that fostamatinib demonstrated a consistently well-tolerated safety profile for hospitalized patients with COVID-19 in this trial,” said Dr. Jeffrey R. Strich, principal investigator of the study and a physician at the NIH Clinical Center. “Additional studies are needed to confirm the efficacy findings and show how fostamatinib may address the dysregulated immune response observed in COVID-19 patients.”
Results were published online in a manuscript titled “Fostamatinib for the treatment of hospitalized adults with COVD-19, A randomized trial" and can be accessed here.
“We are not only encouraged by the drug’s safety profile, but also are excited by the suggestion of improved outcomes," said Dr. Steven D. Nathan, medical director of advanced lung disease and the lung transplant program at Inova. "This study lays a solid foundation for the phase 3 clinical trial which is needed to confirm these results and which is now underway.”
Raul Rodriguez, president and CEO of Rigel, said the larger Phase 3 clinical trial will be completed later this year.