Natural History, Disease Progression, and Long-Term Neurologic Sequelae of Ebola Virus Disease (EVD) Survivors in PREVAIL III

NCT05494801 | Completed

• 2 other identifiers: 10000727000727-I
• Study Type: observational
• Target: 203
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ebola Virus Disease

Keywords

Emerging Infectious Disease; Hemorrhagic Fever; NEUROLOGIC SEQUELAE; Natural History

Outcome Measures

Primary Outcomes (1)

• Neurological Sequelae

  To characterize the neurological sequelae in EVD survivors after over 5 years convalescence from EVD

  5 years post initial enrollment in PREVAIL III

Secondary Outcomes (1)

• Harmonize data

  5 years post initial enrollment in PREVAIL III

Study Arms (2)

Close Contacts

Close Contacts of EVD survivors, who were also previously in the PREVAIL III Neurology Substudy

Patients (EVD Survivors)

Participants with a history of Ebola Virus Disease who were involved in the Neurology Substudy of the PREVAIL III Ebola Natural History Study

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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).

You may qualify if:

• In order to be eligible to participate in this study, an individual must meet all of the following criteria:
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Male or female, aged 18 or older
• Previous participant in the PREVAIL III Neurology Substudy, either as an EVD survivor or close contact\*
• Ability of subject to understand and the willingness to sign a written informed consent document, or indicate consent with the help of visual aids in the case of illiterate participants.
• Close contacts are those who had a relationship with someone who survived EVD, but were never diagnosed with EVD themselves.

You may not qualify if:

• An individual who meets any of the following criteria will be excluded from participation in this study:
• At the time of enrollment, lacks consent capacity due to cognitive impairment that would make them incapable of understanding the explanation of the procedures in this study. Cognitive capacity to consent will be determined at the time of enrollment. Participants with mental disorders or those participants who are cognitively impaired yet still retain consent capacity will not be excluded.
• Is unable to comply with the procedures of the protocol.
• Has any condition in the judgement of the study staff that would make the volunteer unable to participate in the study.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

John F. Kennedy Medical Center

Monrovia, Liberia

Location

MeSH Terms

Conditions

Hemorrhagic Fever, Ebola; Communicable Diseases, Emerging; Hemorrhagic Fevers, Viral

Condition Hierarchy (Ancestors)

RNA Virus Infections; Virus Diseases; Infections; Filoviridae Infections; Mononegavirales Infections; Communicable Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Bridgette J Billioux, M.D.

  National Institute of Allergy and Infectious Diseases (NIAID)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2022
• First Posted: August 10, 2022
• Study Start: August 25, 2022
• Primary Completion: March 25, 2023
• Study Completion: March 25, 2023
• Last Updated: July 18, 2025

Record last verified: 2025-07

Locations

LI (1)