Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201503001065306 Date of Approval: 10/03/2015
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Putative Investigational Therapeutics in the Treatment of Patients With Known Ebola Infection
Official scientific title A Multicenter Randomized Safety and Efficacy Study of Putative Investigational Therapeutics in the Treatment of Patients with Known Ebola Infection
Brief summary describing the background and objectives of the trial This is a randomized, controlled trial of experimental Ebola virus disease therapies compared to current optimized standard of care (oSOC). The trial allows for a series of pairwise comparisons of novel interventions against a background of optimized medical care, with the goal of determining whether one or more of these interventions can improve the mortality over that achievable through oSOC alone. The study will be initiated with ZMappTM as the lead investigational therapy. The study enrollment is open-ended, as determined by the extent and duration of the ongoing Ebola crisis in West Africa, with an accrual ceiling of 1,000 subjects with known Ebola infection in a combined Phase 1/2 study.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) MCM RCT in EBOV
Disease(s) or condition(s) being studied Ebola,Infections and Infestations
Sub-Disease(s) or condition(s) being studied Ebola
Purpose of the trial Treatment: Drugs
Anticipated trial start date 11/03/2015
Actual trial start date 13/03/2015
Anticipated date of last follow up 31/12/2016
Actual Last follow-up date
Anticipated target sample size (number of participants) 1000
Actual target sample size (number of participants) 72
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
15-I-0083 National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH)
NCT02363322 ClinicalTrials.gov
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Randomization scheme generated by the Data Management Center Open-label(Masking Not Used)
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Randomization scheme generated by the Data Management Center Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Optimized Standard-of-Care 28 Days aggressive fluid replacement, hemodynamic support, electrolyte monitoring and replacement, and other measures of advanced medical support 100
Experimental Group ZMapp Infusion concentration of 4 mg/mL 28 Days a combination of 3 different humanized monoclonal antibodies against the glycoprotein of Ebola 100
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
-Males or females with documented positive PCR for Ebola virus infection within 10 days of enrollment -Willingness of study participant to accept randomization to any assigned treatment arm -Access to oSOC -All males and females of childbearing potential, must be willing to use highly effective [e.g. absolute abstinence from potentially reproductive sexual activity, hormonal, surgical or multiple barrier/combined] methods of contraception, from time of enrollment through at least 90 days after viral clearance -Must agree not to enroll in another study of an investigational agent prior to completion of last required protocol visit -Ability to provide informed consent personally, or by a legally-authorized [per applicable local laws and regulations] representative [LAR] if the patient is unable to do so. -Any medical condition that, in the opinion of the site investigator, would place the patient at an unreasonably increased risk through participation in this study, including any past or concurrent conditions that would preclude randomization to one or more of the assigned treatment arms (e.g., severe nausea and vomiting precluding use of oral therapies). -Prior treatment with any investigational antiviral drug therapy against Ebola infection or investigational anti-Ebola vaccine within 5 half lives or 30 days, whichever is longer, prior to enrollment. -Patients who, in the judgment of the investigator, will be unlikely to comply with the requirements of this protocol 0 Year(s) 100 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 23/02/2015 The National Research Ethics Board
Ethics Committee Address
Street address City Postal code Country
Charlesville, Margibi County Liberia
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 29/01/2015 National Institute of Allergy and Infectious Diseases, National Institutes of Health, Institutional Review Board
Ethics Committee Address
Street address City Postal code Country
5601 Fishers Lane Bethesda 20892 United States of America
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes Sierra Leone Ethics and Scientific Review Committee
Ethics Committee Address
Street address City Postal code Country
Central Medical Stores, New England Ville Freetown Sierra Leone
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 18/03/2015 Emory Institutional Review Board
Ethics Committee Address
Street address City Postal code Country
1599 Clifton Road, 5th Floor Atlanta 30322 United States of America
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 12/03/2015 University of Nebraska Medical Center Institutional Review Board
Ethics Committee Address
Street address City Postal code Country
Academic and Research Services Building 3000 / 987830 Nebraska Medical Center Omaha 68198 United States of America
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Mortality 28 Days
Secondary Outcome Adverse Events Throughout
Secondary Outcome Clinical and virology effects of experimental treatment 28 Days
Secondary Outcome Plasma Viral Load Throughout
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Jui Chinese Hospital Freetown Sierra Leone
NIH Clinical Research Center 10 Center Drive Bethesda 20892 United States of America
UK Kerry Town Ebola Treatment Center Kerry Town Sierra Leone
ADRA Ebola Treatment Unit Waterloo Sierra Leone
34 Military Hospital Freetown Sierra Leone
1 Police Training School Freetown Sierra Leone
International Medical Corps. Ebola Treatment Center. Lunsar Lunsar, Port Loko District Sierra Leone
International Medical Corps, Kambia Kambia District Sierra Leone
GOAL ETC Port Loko District Sierra Leone
ELWA2 Hospital Robert's Field Highway LR-Paynesville Liberia
EMERGENCY NGO Ebola Treatment Unit Goderich Sierra Leone
CTE Forecariah Forecariah Guinea
International Medical Corps., Ebola Treatment Center, Makeni Makeni Sierra Leone
Monrovia Medical Unit Marigibi County Liberia
Emory University Hospital 1364 Clifton Road Atlanta 30322 United States of America
Police Training School 2 Hastings Freetown Sierra Leone
University of Nebraska Medical Center 985330 Nebraska Medical Center Omaha 68198 United States of America
FUNDING SOURCES
Name of source Street address City Postal code Country
National Institutes of Health (NIH) Center Drive Bethesda 20892 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor National Institute of Allergy and Infectious Diseases 5601 Fishers Lane Bethesda 20892 United States of America Funding Agency
COLLABORATORS
Name Street address City Postal code Country
Not Applicable
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Foday Sahr fsahr@yahoo.com 00232-76480288 34 Military Hospital at Wilberforce
City Postal code Country Position/Affiliation
Freetown Sierra Leone Associate Professor, COMAHS, USL
Role Name Email Phone Street address
Principal Investigator Christopher Kratochvil ckratoch@unmc.edu 402-559-8480 987878 Nebraska Medical Center
City Postal code Country Position/Affiliation
Omaha 68198 United States of America Associate Vice-Chancellor for Clin ical Research, Vice President for Research, UNMC
Role Name Email Phone Street address
Principal Investigator Moses Massaquoi mosesdr45@yahoo.com 231-634-3887 JFK Compound
City Postal code Country Position/Affiliation
Monrovia Liberia President, LMDA
Role Name Email Phone Street address
Principal Investigator Richard Davey rdavey@niaid.nih.gov 301-496-8029 10 Center Drive, Rm. 4-1479, MSC 1460
City Postal code Country Position/Affiliation
Bethesda 20892 United States of America Deputy Clinical Director, NIAID, NIH
Role Name Email Phone Street address
Principal Investigator Joseph Fontana fontanaj@nhlbi.nih.gov 301-451-7740 10 Center Drive, RM 5-1421; MSC 1570
City Postal code Country Position/Affiliation
Bethesda 20892 United States of America LCDR, USPHS, Chief Medical Officer, NIH Clinical Center
Role Name Email Phone Street address
Principal Investigator Herbert Kallon herbertkallon@gmail.com 23276253220 12 Wesley Street
City Postal code Country Position/Affiliation
Freetown Sierra Leone Police Training School 2
Role Name Email Phone Street address
Principal Investigator Komba Songu-M'Briwa patmoore.ks@gmail.com 23279327081 Police Training School I, Hastings
City Postal code Country Position/Affiliation
Freetown Sierra Leone Clinical Lead - PTS1 Ebola Treatment Center
Role Name Email Phone Street address
Principal Investigator Herbert Kallon herbertkallon@gmail.com 23276253220 12 Wesley Street
City Postal code Country Position/Affiliation
Freetown Sierra Leone Police Training School 2
Role Name Email Phone Street address
Principal Investigator Komba Songu-M'Briwa patmoore.ks@gmail.com 23279327081 Police Training School I, Hastings
City Postal code Country Position/Affiliation
Freetown Sierra Leone Clinical Lead - PTS1 Ebola Treatment Center
Role Name Email Phone Street address
Principal Investigator Komba Songu-M'Briwa patmoore.ks@gmail.com 23279327081 Police Training School I, Hastings
City Postal code Country Position/Affiliation
Freetown Sierra Leone Clinical Lead - PTS1 Ebola Treatment Center
Role Name Email Phone Street address
Principal Investigator Gino Strada g.strada@emergency.it 232 (0) 76142683 Emergency Ebola Treatment Unit, Goderich
City Postal code Country Position/Affiliation
Freetown Sierra Leone Executive Director of the NGO EMERGENCY
Role Name Email Phone Street address
Principal Investigator Komba Songu-M'Briwa patmoore.ks@gmail.com 23279327081 Police Training School I, Hastings
City Postal code Country Position/Affiliation
Freetown Sierra Leone Clinical Lead - PTS1 Ebola Treatment Center
Role Name Email Phone Street address
Principal Investigator Rashidatu Kamara kamara_rashidatufouad@yahoo.com 076260744 Waterloo
City Postal code Country Position/Affiliation
Freetown Sierra Leone Clinical Lead, ADRA Ebola Treatment Unit
Role Name Email Phone Street address
Principal Investigator Yong-Feng Yang henanyyf@hotmaif.com 86 25 83626206 1-1 Zhongfu Road
City Postal code Country Position/Affiliation
Nangjing 210003 China Physician, The Second Hospital of Nan Jing
Role Name Email Phone Street address
Principal Investigator Reginald Cole regwardcole@yahoo.com 079061293 16 Industrial Area, Wellington
City Postal code Country Position/Affiliation
Freetown Sierra Leone Centre Clinician, PTS 2, Ebola tTeatment Centre
Role Name Email Phone Street address
Principal Investigator Jean-Charles Nied jc.nied@hotmail.fr 01.47.83.52.17 34, rue Miollis
City Postal code Country Position/Affiliation
Paris 75015 France Medical-Surgical Care
Role Name Email Phone Street address
Principal Investigator Alseny Modet Camara modeste1979@gmail.com 628-187-806 Q/Simbaya Gare
City Postal code Country Position/Affiliation
Conakry Guinea Managing Physician of the Coyah ETC
Role Name Email Phone Street address
Principal Investigator Aboubacar Keira Camara keiracamara@gmail.com (00224) 624.304.366
City Postal code Country Position/Affiliation
Forecariah Guinea Supervising Physician for the Forécariah ETC
Role Name Email Phone Street address
Public Enquiries Laurie Doepel ldoepel@niaid.nih.gov 301-435-8595 31 Center Dr, MSC 2520
City Postal code Country Position/Affiliation
Bethesda 20892 United States of America Senior Advisor for Science Communications
Role Name Email Phone Street address
Scientific Enquiries Richard Davey rdavey@niaid.nih.gov 301-496-8029 10 Center Drive, Rm. 4-1479, MSC 1460
City Postal code Country Position/Affiliation
Bethesda 20892 United States of America Deputy Clinical Director, NIAID, NIH
REPORTING
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