Ebola Virus Disease Survivors: Clinical and Immunologic Follow-up

Ebola Virus Disease Clinical Trial

Official title:

Partnership for Research on Ebola Virus (PREVAIL) Prevail III: Ebola Natural History Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02431923
• Other study ID #: 150122
• Secondary ID: 15-I-0122
• Status: Completed
• Start date: December 2, 2017
• Est. completion date: April 30, 2021

Study information

• Verified date: October 2022
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4043
• Est. completion date: April 30, 2021
• Est. primary completion date: April 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 100 Years

Eligibility

• INCLUSION CRITERIA FOR EVD SURVIVORS

A volunteer of any age with a diagnosis of EVD within the past 2 years who is on the Ministry of Health (MOH) Registry of EVD survivors is eligible to participate.

• Willingness to participate in examinations at one of the participating health facilities

• Willingness to provide informed consent/assent

Individuals on the MOH Registry were PCR positive for EVD and treated at an Ebola Treatment Unit (ETU), Community Care Center (CCC) or holding center. Periodically, participants enrolled will be matched against the MOH Registry to verify that those enrolled are EVD survivors. If a participant enrolled is not on the registry, their antibody levels at baseline will be assessed. If antibody levels are present, the participant will continue to be followed as an EVD survivor. If antibody levels are not present, the participants will no longer be followed as an EVD survivor and may be withdrawn from the study. Participants brought to the NIH Clinical Center will have documentation of positive Ebola virus PCR and a clinical syndrome compatible with acute EVD.

EXCLUSION CRITERION FOR EVD SURVIVORS

Any condition in the judgment of the study staff that would make the volunteer unable to participate in the study.

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Liberia	CH Rennie Hospital	Kakata
Liberia	Duport Clinic	Monrovia
Liberia	JFK Hospital	Monrovia
United States	National Institutes of Health Clinical Center	Bethesda	Maryland

Sponsors (1)

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

Countries where clinical trial is conducted

United States,  Liberia, 

References & Publications (2)

Kibadi K, Mupapa K, Kuvula K, Massamba M, Ndaberey D, Muyembe-Tamfum JJ, Bwaka MA, De Roo A, Colebunders R. Late ophthalmologic manifestations in survivors of the 1995 Ebola virus epidemic in Kikwit, Democratic Republic of the Congo. J Infect Dis. 1999 Feb;179 Suppl 1:S13-4. — View Citation

Rowe AK, Bertolli J, Khan AS, Mukunu R, Muyembe-Tamfum JJ, Bressler D, Williams AJ, Peters CJ, Rodriguez L, Feldmann H, Nichol ST, Rollin PE, Ksiazek TG. Clinical, virologic, and immunologic follow-up of convalescent Ebola hemorrhagic fever patients and their household contacts, Kikwit, Democratic Republic of the Congo. Commission de Lutte contre les Epidémies à Kikwit. J Infect Dis. 1999 Feb;179 Suppl 1:S28-35. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To characterize the clinical sequelae seen in convalescent Ebola virus disease (EVD) patients.	longterm sequelae, ability to transmit Ebola, or long-term protective immunity in survivors convalescing from EVD	Throughout
Primary	Assess whether convalescent EVD patients can transmit infection to household and sexual contacts as determined by development of EVD or Ebola seroconversion in contacts	longterm sequelae, ability to transmit Ebola, or long-term protective immunity in survivors convalescing from EVD	Throughout
Secondary	Better define the immune response in EVD survivors.	longterm sequelae, ability to transmit Ebola, or long-term protective immunity in survivors convalescing from EVD	Throughout

External Links

•   NIH Clinical Center Detailed Web Page