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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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17 October 2022 |
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Main ID: |
NCT02431923 |
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Date of registration:
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30/04/2015 |
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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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Ebola Virus Disease Survivors: Clinical and Immunologic Follow-up
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Scientific title:
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Partnership for Research on Ebola Virus (PREVAIL) Prevail III: Ebola Natural History Study |
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Date of first enrolment:
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December 2, 2017 |
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Target sample size:
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4043 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02431923 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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Liberia
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United States
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Contacts
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Name:
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Michael C Sneller, 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 FOR EVD SURVIVORS
A volunteer of any age with a diagnosis of EVD within the past 2 years who is on the
Ministry of Health (MOH) Registry of EVD survivors is eligible to participate.
- Willingness to participate in examinations at one of the participating health
facilities
- Willingness to provide informed consent/assent
Individuals on the MOH Registry were PCR positive for EVD and treated at an Ebola Treatment
Unit (ETU), Community Care Center (CCC) or holding center. Periodically, participants
enrolled will be matched against the MOH Registry to verify that those enrolled are EVD
survivors. If a participant enrolled is not on the registry, their antibody levels at
baseline will be assessed. If antibody levels are present, the participant will continue to
be followed as an EVD survivor. If antibody levels are not present, the participants will
no longer be followed as an EVD survivor and may be withdrawn from the study. Participants
brought to the NIH Clinical Center will have documentation of positive Ebola virus PCR and
a clinical syndrome compatible with acute EVD.
EXCLUSION CRITERION FOR EVD SURVIVORS
Any condition in the judgment of the study staff that would make the volunteer unable to
participate in the study.
Age minimum:
N/A
Age maximum:
100 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Ebola Virus Disease
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Primary Outcome(s)
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Assess whether convalescent EVD patients can transmit infection to household and sexual contacts as determined by development of EVD or Ebola seroconversion in contacts
[Time Frame: Throughout]
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To characterize the clinical sequelae seen in convalescent Ebola virus disease (EVD) patients.
[Time Frame: Throughout]
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Secondary Outcome(s)
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Better define the immune response in EVD survivors.
[Time Frame: Throughout]
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Secondary ID(s)
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150122
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15-I-0122
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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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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