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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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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02363322 |
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Date of registration:
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13/02/2015 |
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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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Putative Investigational Therapeutics in the Treatment of Patients With Known Ebola Infection
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Scientific title:
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A Multicenter Randomized Safety and Efficacy Study of Putative Investigational Therapeutics in the Treatment of Patients With Known Ebola Infection |
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Date of first enrolment:
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March 13, 2015 |
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Target sample size:
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72 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02363322 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 1/Phase 2
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Countries of recruitment
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Guinea
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Liberia
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Sierra Leone
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United States
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Contacts
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Name:
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Richard T Davey, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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National Institute of Allergy and Infectious Diseases (NIAID) |
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Key inclusion & exclusion criteria
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- INCLUSION CRITERIA:
- 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 methods of contraception [e.g. absolute abstinence from potentially
reproductive sexual activity, hormonal, surgical or multiple barrier/combined], from
time of enrollment for the duration of study participation.
- Must agree not to enroll in another study of an investigational agent prior to
completion of last required protocol visit (Day 58)
- 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.
EXCLUSION CRITERIA:
- 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.
- Prior treatment with any investigational antiviral drug therapy against Ebola
infection other than experimental vaccines, within 5 half-lives or 30 days, whichever
is longer, prior to enrollment
Age minimum:
N/A
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Ebola Virus Infection
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Intervention(s)
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Other: A/Current Standard of Care Alone
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Drug: B/Current Standard of Care Plus ZMapp
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Primary Outcome(s)
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Mortality
[Time Frame: 28 days]
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Secondary Outcome(s)
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Plasma Viral Load
[Time Frame: 28 days]
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Number of Participants With ZMapp Infusion-related Adverse Events
[Time Frame: 10 Days]
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Secondary ID(s)
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15-I-0083
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150083
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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