Congo-Kinshasa: Board Recommends Early Termination of Ebola Trial Because of Favorable Results with Two Candidates

A caregiver with the seven-month-old baby of a woman who died of Ebola in North Kivu,

The Pamoja Tulinde Maisha (PALM [together save lives]) study is usually a randomized, controlled trial of four investigational agents (ZMapp, remdesivir, mAb114 in addition to REGN-EB3) for the treatment of patients with Ebola virus disease. The study began on Nov. 20, 2018 within the Democratic Republic of the Congo (DRC) as part of the emergency response to an ongoing Ebola outbreak within the North Kivu in addition to Ituri Provinces.

As of Aug. 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 in addition to Mangina. These ETCs have been overseen by staff through the Institut National de Recherche Biomédicale (INRB); the DRC Ministry of Health; in addition to three medical humanitarian organizations: the Alliance for International Medical Action (ALIMA), the International Medical Corps (IMC), in addition to Médecins Sans Frontières (MSF).

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

The principal investigators of the study, its statistician in addition to its co-sponsors accepted This particular recommendation, in addition to the ETC staff at the sites were promptly informed. In addition to limiting future patient randomizations to REGN-EB3 in addition to mAb114, patients who were randomized to ZMapp or remdesivir within the last 10 days right now contain 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 are generated in addition to collected (likely late September/early October 2019), the DSMB in addition to the study leadership felt the preliminary analysis of the existing data was compelling enough to recommend in addition to implement these alterations within the trial immediately. The complete results will be submitted for publication within the peer-reviewed medical literature as soon as possible.

The study is usually co-sponsored in addition to funded by the INRB in addition to the National Institute of Allergy in addition to Infectious Diseases (NIAID) of the U.S. National Institutes of Health; carried out by an international research consortium coordinated by the entire world Health Organization (WHO); in addition to supported by four pharmaceutical companies (MappBio, Gilead, Regeneron, in addition to Ridgeback Biotherapeutics).

NIAID, INRB in addition to the WHO thank the extraordinary team of individuals who have worked under extremely difficult conditions to carry out This particular study, the members of the DSMB, in addition to, most importantly, the patients who participated within the study in addition to their families. in which is usually through This particular type of rapidly implemented, rigorous research in which we can quickly in addition to definitively identify the best treatments in addition to incorporate them into the Ebola outbreak response.

Who

The following spokespersons are available: NIAID Director Anthony S. Fauci, M.D.; INRB Director-General Professor Jean-Jacques Muyembe-Tamfum, M.D., Ph.D.; in addition to Michael J. Ryan, M.D., Executive Director, WHO Health Emergencies Programme.

NIAID conducts in addition to supports research—at NIH, throughout the United States, in addition to worldwide — to study the causes of infectious in addition to immune-mediated diseases, in addition to to develop better means of preventing, diagnosing in addition to treating these illnesses. News releases, fact sheets in addition to different NIAID-related materials are available on the NIAID Web site at www.niaid.nih.gov.

About the National Institutes of Health (NIH): NIH, the nation’s medical research agency, includes 27 Institutes in addition to Centers in addition to is usually a component of the U.S. Department of Health in addition to Human Services. NIH is usually the primary federal agency conducting in addition to supporting basic, clinical, in addition to translational medical research, in addition to is usually investigating the causes, treatments, in addition to cures for both common in addition to rare diseases. For more information about NIH in addition to its programs, visit www.nih.gov.

Congo-Kinshasa: Board Recommends Early Termination of Ebola Trial Because of Favorable Results with Two Candidates

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