Ebola Virus Disease Survivors: Clinical and Immunologic Follow-up

Completed

• Conditions: Ebola Virus Disease

• Registration Number: NCT02431923
• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Brief Summary

Background:

- Ebola is a lethal disease. A lot is still unknown about Ebola and its long-term effects. Researchers want to learn what ill health conditions Ebola survivors have. They want to learn if Ebola survivors can infect others in their household through close contact. They also want to learn if Ebola survivors are immune from getting Ebola again. To learn these things, they want to follow people in Liberia for 5 years.

Objectives:

- To learn how Ebola affects the health of survivors and the people they live with.

Eligibility:

- People in Liberia who had Ebola in the past 2 years, who share a household with someone who had Ebola, or who got ill and went to an Ebola Treatment Unit but were sent home because they did not have Ebola.

Design:

* Participants will be screened with family illness history, physical exam, and blood tests. They may have an eye exam.

* Ebola survivors and those who went to a Treatment Unit but did not have Ebola will visit a clinic at 3, 6, and 12 months, then every 6 months for 5 years. At each visit, they will repeat the screening tests.

* Participants who live with someone who had Ebola will have only the screening visit. But they may be asked to return for follow-up visits. These visits will help researchers learn more about the differences between those who have had Ebola and those who have not.

* Participants brought to the NIH Clinical Center will have documentation of positive Ebola virus PCR and a clinical syndrome compatible with acute EVD.

* The study will last 5 years.

Detailed Description

Between 1994 and the present, there have been several Ebola virus outbreaks affecting mostly countries in Central Africa. However, the 2014 West African outbreak significantly exceeds all previous outbreaks in geographic range and number of individuals affected. Ebola virus disease (EVD) is highly lethal with case fatality rates of 70-80% in the current West African outbreak. While the clinical manifestations of acute Ebola virus infection are well documented, little is known about long-term sequelae, ability to transmit Ebola, or long-term protective immunity in survivors from EVD. The purpose of this protocol is to study these questions in a cohort of EVD survivors from Liberia.

Study Timeline

• Study First Submitted: 2015-04-30
• Study First Submitted QC: 2015-04-30
• Study First Posted: 2015-05-01
• Study Start: 2017-12-02
• Primary Completion: 2021-04-30
• Study Completion: 2021-04-30
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-07
• Last Update Posted: 2022-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4043

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To characterize the clinical sequelae seen in convalescent Ebola virus disease (EVD) patients.	Throughout	longterm sequelae, ability to transmit Ebola, or long-term protective immunity in survivors convalescing from EVD
Assess whether convalescent EVD patients can transmit infection to household and sexual contacts as determined by development of EVD or Ebola seroconversion in contacts	Throughout	longterm sequelae, ability to transmit Ebola, or long-term protective immunity in survivors convalescing from EVD

Secondary Outcome Measures

Name	Time	Method
Better define the immune response in EVD survivors.	Throughout	longterm sequelae, ability to transmit Ebola, or long-term protective immunity in survivors convalescing from EVD

Trial Locations

Locations (4)

CH Rennie Hospital; 🇱🇷 Kakata, Liberia

National Institutes of Health Clinical Center; 🇺🇸 Bethesda, Maryland, United States

JFK Hospital; 🇱🇷 Monrovia, Liberia

Duport Clinic; 🇱🇷 Monrovia, Liberia