A Multicenter Randomized Safety and Efficacy Study of Putative Investigational Therapeutics in the Treatment of Patients With Known Ebola Infection
Sponsor study identifier
Secondary identifiers
OTHER · NIH Office of Protocol Services
interventional
72
4 countries
11
Study Start
March 13, 2015
Actual (reported)Primary Completion
December 31, 2017
Actual (reported)Study Completion
December 31, 2017
Actual (reported)Background: \- Ebola is a viral infection that can spread quickly and causes life-threatening disease. Right now there is an Ebola outbreak in many countries in West Africa. There are no approved treatments for Ebola. But possible treatments are being developed. Researchers need to study these treatments to see if they help people get better. Objective: \- To identify possible Ebola treatments. Also, to learn if adding 1 or more experimental drugs to advanced Ebola care can reduce the risk of death. Eligibility: \- People who have recently been diagnosed with Ebola, usually by a test called the Polymerase Chain Reaction (PCR), and have been hospitalized in an isolation unit for treatment. Design:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2017
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 13, 2015
Actual (reported)February 16, 2015
Actual (reported)March 13, 2015
Actual (reported)December 31, 2017
Actual (reported)December 31, 2017
Actual (reported)May 14, 2019
Actual (reported)Mortality
Death at Day 28
28 days
Number of Participants With ZMapp Infusion-related Adverse Events
10 Days
Plasma Viral Load
28 days
A/Current Standard of Care Alone: Optimized standard of care to include aggressive fluid resuscitation, hemodynamic support, and other interventions available in an optimized care setting
B/Current Standard of Care Plus ZMapp: ZMapp (Trademark) + Optimized standard of care to include aggressive fluid resuscitation, hemodynamic support, and other interventions available in an optimized care setting. ZMapp 50mg/kg IV administered every third day for 3 infusions.
Triple monoclonal cocktail of antibodies against Zaire species of Ebola virus
Optimized standard of care for Ebola virus infection
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892, United States
CTE Forecariah
Forécariah, Guinea
Monrovia Medical Unit
Monrovia, Liberia
ELWA III Hospital
Paynesville, Liberia
Police Training School 1 (PTS1), Western Rural District
Freetown, Sierra Leone
Emergency Ebola Treatment Unit
Goderich, Sierra Leone
Police Training School 2
Hastings, Sierra Leone
Joffe S. Evaluating novel therapies during the Ebola epidemic. JAMA. 2014 Oct 1;312(13):1299-300. doi: 10.1001/jama.2014.12867. No abstract available.
Kanapathipillai R. Ebola virus disease--current knowledge. N Engl J Med. 2014 Sep 25;371(13):e18. doi: 10.1056/NEJMp1410741. No abstract available.
Piot P, Muyembe JJ, Edmunds WJ. Ebola in west Africa: from disease outbreak to humanitarian crisis. Lancet Infect Dis. 2014 Nov;14(11):1034-1035. doi: 10.1016/S1473-3099(14)70956-9. Epub 2014 Oct 1. No abstract available.
Due to the severity of the underlying illness (Ebola infection) only infusion-related adverse events were captured.
Richard T Davey, M.D.
National Institute of Allergy and Infectious Diseases (NIAID)
72 participants (actual enrollment reported by the registry).
First Submitted
February 13, 2015
First Posted
February 16, 2015
Study Start
March 13, 2015
Actual (reported)Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Chinese Friendship Hospital
Jui, Sierra Leone
International Medical Corps (IMC) Kambia
Kambia, Sierra Leone
International Medical Corps (IMC) Lunsar
Port Loko, Sierra Leone
Adventist Development and Relief Ebola Treatment Unit
Waterloo, Sierra Leone
PREVAIL II Writing Group; Multi-National PREVAIL II Study Team; Davey RT Jr, Dodd L, Proschan MA, Neaton J, Neuhaus Nordwall J, Koopmeiners JS, Beigel J, Tierney J, Lane HC, Fauci AS, Massaquoi MBF, Sahr F, Malvy D. A Randomized, Controlled Trial of ZMapp for Ebola Virus Infection. N Engl J Med. 2016 Oct 13;375(15):1448-1456. doi: 10.1056/NEJMoa1604330.
Primary Completion
December 31, 2017
Actual (reported)Study Completion
December 31, 2017
Actual (reported)Last Updated
June 5, 2019
Results First Posted
May 14, 2019
Record last verified: 2018-06
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Source: ClinicalTrials.gov.
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