An observational study in Ebola Virus Disease, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Completed at 1 site in Liberia. Open to participants aged 18 Years to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-18.
Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Observational
Background:
Ebola virus disease (EVD) is a viral fever that can cause internal bleeding. The death rate from EVD is very high. In a 2014 outbreak in West Africa, 28,000 were affected and 11,000 died. EVD may also affect the brain and nervous system, but this is not well studied. People with EVD report headaches and mental status changes. Some rarely had strokes and seizures. Neurological issues can continue for years after people recover from the initial EVD infection.
Objective:
This is a natural history study to learn more about how EVD continues to affect survivors brain and nervous system after 5 years.
Eligibility:
People aged 18 years or older who participated in the PREVAIL III Neurology Substudy. Participants can be either an EVD survivor or a close contact. Close contacts are people who had a relationship with a survivor of EVD.
Design:
Participants will have 1 clinic visit.
They will have a physical exam. Their vital signs will be measured. They will also have a neurological checkup. The exam will assess their mental status. Their senses, reflexes, and coordination will be tested. They will be observed while walking to assess their gait. This exam will take about 1 hour.
Participants will have an interview. They will answer questions about any symptoms they have that may be affecting the brain or nervous system. This will take about 1 hour.
No other procedures will be performed during this visit.
Study Description:
The long-term neurological sequelae of Ebola virus disease are not welldescribed. Through the PREVAIL III (PIII) Ebola Natural History Study, a Neurology Substudy was undertaken to better understand the long-term neurologic sequelae of EVD, with 5 years of follow up planned. Unfortunately, due to the COVID-19 pandemic beginning in early 2020, the final study evaluations of the PIII Neurology Substudy participants were unable to be performed by study staff based in the United States. To better understand the long-term neurological sequelae of EVD survivors, we propose this single-visit observational study of the participants of the Neurology Substudy of PIII. We hypothesize that, although the EVD survivors neurological issues have improved over time, they still may have neurological sequelae even after over 5 years convalescence from EVD.
Objectives:
Primary Objective: To characterize the neurological sequelae in EVD survivors after over 5 years convalescence from EVD
Secondary Objectives: To harmonize data from PIII Neurology substudy to determine how the prevalence of neurological complaints and neurological exam abnormalities changed over time.
Endpoints:
Primary Endpoint: The prevalence of neurological complaints and neurological exam abnormalities in EVD survivors after 5 years or more of convalescence from EVD, in comparison to close contacts.
Secondary Endpoints: The change of neurological complaints and neurological exam abnormalities in EVD survivors over time.
104 studies on the registry are indexed under Hemorrhagic Fever, Ebola; 13 are open to participants now.
This study's enrollment of 203 is below the median of 266 across 16 observational studies indexed under Hemorrhagic Fever, Ebola.
Browse Hemorrhagic Fever, Ebola studies →National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,446 studies on the registry; 179 are open to participants now.
Of its 405 completed or terminated interventional studies of FDA-regulated products, 302 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
The study will include all of the participants who were involved in the Neurology Substudy of the PREVAIL III Ebola Natural History Study who are willing to join. The Neurology Substudy originally included 172 self-identified EVD survivors and 93 self-identified close contacts. Since inclusion into the PIII study and Neurology substudy, there is bound to be some attrition (with a few participants who have passed away, some who have moved away from the area, some who simply may no longer wish to participate, among other reasons for attrition).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
Close contacts are those who had a relationship with someone who survived EVD, but were never diagnosed with EVD themselves.
EXCLUSION CRITERIA:
An individual who meets any of the following criteria will be excluded from participation in this study:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Close Contacts of EVD survivors, who were also previously in the PREVAIL III Neurology Substudy
Participants with a history of Ebola Virus Disease who were involved in the Neurology Substudy of the PREVAIL III Ebola Natural History Study
Neurological Sequelae
To characterize the neurological sequelae in EVD survivors after over 5 years convalescence from EVD
Time frame: 5 years post initial enrollment in PREVAIL III
Harmonize data
To harmonize data from PIII Neurology substudy to determine how the incidence of neurological complaints and neurological exam abnormalities changed over time
Time frame: 5 years post initial enrollment in PREVAIL III
Plan to share: Undecided — We plan to share IPD that is clinically relevant and IPD that underlie results in publication.
No publications or documents are linked to this record.
This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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National Institute of Allergy and Infectious Diseases (NIAID) →