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Ebola Virus Disease Survivors: Clinical and Immunologic Follow-up

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ClinicalTrials.gov Identifier: NCT02431923
Recruitment Status : Active, not recruiting
First Posted : May 1, 2015
Last Update Posted : January 28, 2021
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )

Tracking Information
First Submitted Date April 30, 2015
First Posted Date May 1, 2015
Last Update Posted Date January 28, 2021
Actual Study Start Date December 2, 2017
Estimated Primary Completion Date April 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 17, 2019)
  • To characterize the clinical sequelae seen in convalescent Ebola virus disease (EVD) patients. [ Time Frame: 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 [ Time Frame: Throughout ]
    longterm sequelae, ability to transmit Ebola, or long-term protective immunity in survivors convalescing from EVD
Original Primary Outcome Measures
 (submitted: April 30, 2015)
  • To characterize the clinical sequelae seen in convalescent Ebola virus disease (EVD) patients. [ Time Frame: 10 years ]
  • Assess whether convalescent EVD patients can transmit infection to household and sexual contacts as determined by development of EVD or Ebola seroconversion in contacts [ Time Frame: 10 years ]
Change History
Current Secondary Outcome Measures
 (submitted: July 17, 2019)
Better define the immune response in EVD survivors. [ Time Frame: Throughout ]
longterm sequelae, ability to transmit Ebola, or long-term protective immunity in survivors convalescing from EVD
Original Secondary Outcome Measures
 (submitted: April 30, 2015)
Better define the immune response in EVD survivors. [ Time Frame: 10 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Ebola Virus Disease Survivors: Clinical and Immunologic Follow-up
Official Title Partnership for Research on Ebola Virus (PREVAIL) Prevail III: Ebola Natural History Study
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Survivors of EVD, household contacts, non EVD Controls
Condition Ebola Virus Disease
Intervention Not Provided
Study Groups/Cohorts
  • EVD Close Contacts
    At least one of the following:-Household contact of survivor at time of or since EVD event-Sexual contact with survivor since EVD event-Other selected contacts
  • EVD Survivors
    Subject listed on the Ministry of Health registry for Ebola survivors
  • Non Contact Controls
    Selected Controls
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: February 6, 2019)
4043
Original Estimated Enrollment
 (submitted: April 30, 2015)
1500
Estimated Study Completion Date April 30, 2021
Estimated Primary Completion Date April 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria
  • 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.

Sex/Gender
Sexes Eligible for Study: All
Ages up to 100 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Liberia,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02431923
Other Study ID Numbers 150122
15-I-0122
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )
Study Sponsor National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators Not Provided
Investigators
Principal Investigator: Michael C Sneller, M.D. National Institute of Allergy and Infectious Diseases (NIAID)
PRS Account National Institutes of Health Clinical Center (CC)
Verification Date January 25, 2021