Lerato Matheka
The World Health Organisation (WHO) is closing in on cracking the Ebola Virus cure.
The organisation this week revealed four possible treatments trialled on patients of the Ebola Virus in the Democratic Republic of the Congo (DRC).
The Independent Monitoring Board recommends early termination of Ebola Therapeutics Trial in the DRC because of favourable results with two of four candidates. The Pamoja Tulinde Maisha conducted a controlled trial of four investigational agents; ZMapp, remdesivir, mAb114 and REGN-EB3 for the treatment of patients with the Ebola virus.
The study began on November 20, 2018 in the DRC as part of the emergency response to an ongoing Ebola outbreak in the North Kivu and Ituri Provinces, the Organisation said.
It added that as of August 9, 2019, the trial had enrolled 681 patients toward their 725 target.
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 Biomdicale (INRB); the DRC Ministry of Health; and three medical humanitarian organisations; the Alliance for International Medical Action (ALIMA), the International Medical Corps (IMC), and Mecins Sans Frontres (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, it said.
It added that as a result of their August 9, 2019 review, the DSMB recommended that the study be stopped and that all future patients be randomised 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.
WHO indicated that the principal investigators of the study, its statistician and its co-sponsors, accepted the recommendations, and the ETC staff at the sites were promptly informed.
In addition to limiting future patient randomisations to REGN-EB3 and mAb114, WHO noted that patients who were randomised to ZMapp or remdesivir in the last 10 days now have the option, at the discretion of their treating physician, to receive either REGN-EB3 or mAb114.
While the final analysis of the data can occur only after all the data is generated and collected, likely late September or early October 2019, the DSMB and the study leadership felt the preliminary analysis of the existing data was compelling enough to recommend and implement these changes in the trial immediately. The complete results will be submitted for publication in the peer-reviewed medical literature as soon as possible, the international health body said.
It noted that the study is co-sponsored and funded by the INRB and the National Institute of Allergy and Infectious Diseases (NIAID) of the United States National Institutes of Health; carried out by an international research consortium coordinated by the World Health Organization (WHO); and supported by four pharmaceutical companies (MappBio, Gilead, Regeneron, and Ridgeback Biotherapeutics).
NIAID, INRB and the WHO thank the extraordinary team of individuals who have worked under extremely difficult conditions to carry out this study, the members of the DSMB, and, most importantly, the patients who participated in the study and their families. It is through this type of rapidly implemented, rigorous research that we can quickly and definitively identify the best treatments and incorporate them into the Ebola outbreak response, WHO said.
Summary
- The study began on November 20, 2018 in the DRC as part of the emergency response to an ongoing Ebola outbreak in the North Kivu and Ituri Provinces, the Organisation said.
- While the final analysis of the data can occur only after all the data is generated and collected, likely late September or early October 2019, the DSMB and the study leadership felt the preliminary analysis of the existing data was compelling enough to recommend and implement these changes in the trial immediately.
- NIAID, INRB and the WHO thank the extraordinary team of individuals who have worked under extremely difficult conditions to carry out this study, the members of the DSMB, and, most importantly, the patients who participated in the study and their families.
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