WHO in a press release has said that it welcomes the results of the first-ever multi-drug randomized control trial in the Democratic Republic of the Congo aimed at evaluating the safety and efficacy of four drugs used for treatment of Ebola patients. Two out of the four drugs being tested are more effective in treatingEbolaand will bring patients a better chance of survival.Moving forward, these are the only drugs that future patients will be treated with, said WHO.

 

The PamojaTulinde 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.

 

As of August 9, 2019, the trial had enrolled 681 patients toward an enrollment total of 725. Patients were enrolled at four Ebola Treatment Centers (ETCs) in Beni, Katwa, Butembo and Mangina. These ETCs have been overseen by staff from the Institut National de Recherche Biomédicale (INRB); the DRC Ministry of Health; and three medical humanitarian organizations: The Alliance for International Medical Action (ALIMA), the International Medical Corps (IMC), and Médecins Sans Frontières (MSF).

 

The trial is monitored by an independent Data and Safety Monitoring Board (DSMB) that meets periodically to review interim safety and efficacy data and to make recommendations to the study team and the sponsors. As a result of their August 9, 2019 review, the DSMB recommended that the study be stopped and that all future patients be randomized to receive either REGN-EB3 or mAb114 in what is being considered an extension phase of the study. This recommendation was based on the fact that an early stopping criterion in the protocol had been met by one of the products, REGN-EB3. The preliminary results in 499 study participants indicated that those individuals receiving REGN-EB3 or mAb114 had a greater chance of survival compared to those participants in the other two arms.

Two out of the four drugs being tested are more effective in treatingEbolaand will bring patients a better chance of survival.