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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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PACTR |
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Last refreshed on:
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29 May 2023 |
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Main ID: |
PACTR201411000939962 |
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Date of registration:
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14/11/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Rapid Assessment of Potential Interventions & Drugs for Ebola (RAPIDE) - BCV
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Scientific title:
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Open-label, non-randomised single arm trial to investigate the efficacy of Brincidofovir compared to historic controls for Ebolavirus Disease in an outbreak setting in West Africa. |
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Date of first enrolment:
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05/12/2014 |
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Target sample size:
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140 |
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Recruitment status: |
Complete |
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URL:
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https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=939 |
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Study type:
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Interventional |
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Study design:
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Single group: all participants receive same intervention throughout study,Non-randomised
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Phase:
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Not Applicable
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Countries of recruitment
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Liberia
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Contacts
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Name:
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Peter
Horby |
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Address:
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NDM Research Building
OX3 7FZ
Oxford
United Kingdom |
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Telephone:
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+441865612974 |
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Email:
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peter.horby@ndm.ox.ac.uk |
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Affiliation:
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University of Oxford |
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Name:
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Raul
Pardinaz-Solis |
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Address:
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NDM Research Building
OX3 7FZ
Oxford
United Kingdom |
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Telephone:
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+44 01865 612 977 |
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Email:
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raul.pardinaz-solis@ndm.ox.ac.uk |
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Affiliation:
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University of Oxford |
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Key inclusion & exclusion criteria
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Inclusion criteria: Male and female patients 2 months of age or older
Laboratory confirmed infection with Ebolavirus infection.
Women who are lactating must agree to stop breastfeeding (a standard recommendation for all EVD patients)
Willingness to use barrier birth control for 3 months after recovery of EVD (a standard recommendation for all EVD patients)
For patients 18 years and older: the ability to provide fully informed consent or the provision of consent from the representative of a patient deemed too unwell to comprehend what is being asked of them.
For patients under 18 years: consent from a parent or guardian.
Exclusion criteria: Any underlying disease or condition that, in the opinion of the principal investigator or treating physician, could jeopardize the participant¿s or healthcare workers safety or the participant¿s ability to comply with the protocol requirements
Patient unable to take oral IMP (e.g. severe vomiting unresponsive to anti-emetics, unconscious)
Pregnancy
Age minimum:
2 Month(s)
Age maximum:
99 Year(s)
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Ebola
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Ebola
Ebola Virus
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Ebola Virus
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Intervention(s)
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Historical untreated survival rate
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Brincidofovir (BCV)
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Primary Outcome(s)
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Mortality at Day 14 after entry into the trial
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Secondary Outcome(s)
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Convalescent anti-Ebolavirus IgG titer
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Day 4 viral load
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Incidence of SARs and key adverse events
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Mortality at Day 30 after first dose of study treatment
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Presence and duration of symptoms
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Time to meeting EVD treatment center discharge criteria
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Source(s) of Monetary Support
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Wellcome Trust
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Ethics review
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Status: Approved
Approval date: 13/11/2014
Contact:
Oxford Tropical Research Ethics Committee
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Status: Approved
Approval date: 28/11/2014
Contact:
University of Liberia-Pacific Institute for Research & Evaluation Institutional Review Board (UL-PIRE IRB)
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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