Orange’s UCI Medical Center, the first academic medical institution in Southern California to start a trial to test the effectiveness of Gilead Science Inc.’s remdesivir on the coronavirus, has concluded Phase 1, saying the drug demonstrated success over a placebo control group in a double-blind trial run. A second phase is now underway.
The adaptive clinical trial at its Orange facility was part of a batch of testing of almost 1,000 patients across the nation at various institutes, also including University of California-Davis and University of California-San Diego. The nationwide trial is being funded by the National Institute for Allergy and Infectious Diseases.
Foster City-based Gilead on April 29 said its own “simple” trials showed remdesivir helped coronavirus patients recover in 11 days from the coronavirus, or four days faster than a placebo group. Remdesivir, an experimental medicine not yet approved by regulators, is the only antiviral medication in controlled trials to have significantly reduced recovery times for the coronavirus.
Dr. Alpesh Amin, chairman of the Department of Medicine at UCI, told the Business Journal earlier this month that Phase 2 has already made an adjustment by eliminating the placebo control group because it wasn’t necessary to baseline results again.
Next Steps
In the Phase 2 trial, patients will receive either an intravenous administration of remdesivir or a combo of the remdesivir and baricitinib, an immune system inhibitor typically used to treat rheumatoid arthritis.
The Phase 2 trial, which started at the beginning of May, has around 20 or so patients and will last about 29 days.
The drug is administered by IV only, and is not prescribed for outpatient services. Gilead is looking for ways to change the composition of the drug for oral administration, so that patients could potentially be sent home with the medication, according to Amin.
Among questions to be investigated is whether remdesivir reduces the need for intervention by ventilator.
Exclusion criteria for patients wishing to enroll in the Phase 2 trial includes the same factors that would make someone a “high-risk” coronavirus patient—prior heart conditions, liver or kidney issues, or those with an autoimmune disease.
Upcoming phases of the clinical trial will involve the enrollment of up to 30 additional patients at UCI Medical Center, OC’s largest hospital by patient revenue. This later phase will study the effectiveness of Aviptadil, a blood-activated polypeptide that is absorbed through the intestinal wall and can inhibit immune responses in the body.
Chad Lefteris, who at the start of April took over as CEO of the UCI Health system that runs the hospital, is a new addition to this week’s OC 50 listing of influential area business executives. See page 44 for more.
