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

Status: Completed
Location: See location...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: t
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⁃ 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.

Locations
Other Locations
Liberia
John F. Kennedy Medical Center
Monrovia
Time Frame
Start Date: 2022-08-25
Completion Date: 2023-03-25
Participants
Target number of participants: 203
Treatments
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
Sponsors
Leads: National Institute of Allergy and Infectious Diseases (NIAID)

This content was sourced from clinicaltrials.gov

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