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

Ebola Virus Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05494801
• Other study ID #: 10000727
• Secondary ID: 000727-I
• Status: Recruiting
• Start date: August 25, 2022
• Est. completion date: December 1, 2024

Study information

• Verified date: June 10, 2024
• Source: National Institutes of Health Clinical Center (CC)
• Contact: Bridgette J Billioux, M.D.
• Phone: (301) 412-4452
• Email: bridgette.billioux[@]nih.gov
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: December 1, 2024
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

• INCLUSION CRITERIA:

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

1. Stated willingness to comply with all study procedures and availability for the duration of the study

2. Male or female, aged 18 or older

3. Previous participant in the PREVAIL III Neurology Substudy, either as an EVD survivor or close contact*

4. 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.

EXCLUSION CRITERIA:

An individual who meets any of the following criteria will be excluded from participation in this study:

1. 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.

2. Is unable to comply with the procedures of the protocol.

3. Has any condition in the judgement of the study staff that would make the volunteer unable to participate in the study.

Related Conditions & MeSH terms

• Disease Progression
• Ebola Virus Disease
• Hemorrhagic Fever, Ebola
• Virus Diseases

Locations

Country	Name	City	State
Liberia	John F. Kennedy Medical Center	Monrovia

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

Liberia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Harmonize data	To harmonize data from PIII Neurology substudy to determine how the incidence of neurological complaints and neurological exam abnormalities changed over time	5 years post initial enrollment in PREVAIL III