Financed by remdesivir's maker, Gilead Sciences, the study included about 400 COVID-19 patients who were hospitalized but not on a ventilator in 55 hospitals around the world, including the Brigham in Boston and Miriam Hospital in Providence. The combination of baricitinib and remdesivir as a treatment for COVID-19 has not been evaluated in a large, randomized controlled trial to date.
Hershey Medical Center is one of approximately 100 hospitals internationally participating in the continuation of the study and is the only hospital in central Pennsylvania to participate in the clinical trial.
The 450-patient phase 3 trial is pairing Gilead's polymerase inhibitor remdesivir - created to inhibit replication of the virus - with Roche's IL-6 inhibitor Actemra/RoActemra (tocilizumab) which acts as an anti-inflammatory drug. The company said the study, which did not include a placebo comparison, showed that 14 days after treatment with the intravenous drug, 64% of patients treated for 5 days and 54% treated for 10 days showed some clinical improvement.
The COVID-19 drug is still undergoing clinical trials in medical facilities across the globe, including in the UK. Remdesivir is an investigational antiviral drug that is being studied in multiple ongoing global clinical trials, and the safety and efficacy of remdesivir for the treatment of COVID-19 are not yet established.
Mumbai-based BDR Pharmaceuticals has sought the Drug Controller General of India (DCGI)'s approval to manufacture and sell Remdesivir's generic version without entering into a licensing pact with Gilead Sciences, according to an Economic Times report.
The initial portion of the remdesivir trial enrolled 1,063 patients with moderate to severe COVID-19 at 73 national and global sites, including Hershey Medical Center. The primary endpoint is clinical status assessed using a 7-Category Ordinal Scale at day 28.
According to BBC, experts found the early results of Remdesivir studies suggesting that it can shorten the recovery time of the people infected by the novel coronavirus by about four days.
Meanwhile, Roche is continuing to study Actemra, an anti-inflammatory substance originally developed for arthritis.