On August 9, 2019 the independent Data and Safety Monitoring Board (DSMB) recommended the early termination of an Ebola Therapeutics Trial in Democratic Republic of the Congo (DRC) because an early stopping criterion in the protocol had been met by one of the products, REGN-EB3, a monoclonal antibody. They recommended that all future patients be randomized to receive either REGN-EB3 or mAb114 in what is being considered an extension phase of the study. [1, 2]
“The four therapies are administered as intravenous infusions. REGN-EB3 and mAb114 are administered as single infusions and ZMapp and remdesivir are administered as infusions over multiple days.”
“The study was designed to compare mortality among patients who received one of three investigational Ebola drugs with that from a control group of patients who received the investigational monoclonal antibody cocktail ZMapp”…”The mortality rate in the remdesivir treatment group, 53% (93/175), was similar to ZMapp.” Remdesivir increased the risk of deaths and caused renal failure.
Three drugs were supported by US NIH/NIAID and BARDA, and one of the products dropped from the trial, remdesivir is made by Gilead Sciences.
The Pamoja Tulinde Maisha (PALM [together save lives]) study is a randomized, controlled trial of four investigational agents (ZMapp, remdesivir, mAb114 and REGN-EB3) for the treatment of patients with Ebola virus disease. The study began on November 20, 2018 in the Democratic Republic of the Congo (DRC) as part of the emergency response to an ongoing Ebola outbreak in the North Kivu and Ituri Provinces.
The Ebola trial paper was published December 12, 2019 in the New England Journal of Medicine, just 19 days before Gilead posted clinical trial (NCT04292899) for a Phase 3 trial to “[e]valuate the Safety and Antiviral Activity of Remdesivir (GS-5734™)” for use in COVID-19 patients with severe disease! [3, 4, 5]