Ignite Creation Date:
2024-05-05 @ 6:39 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00523276
Status:
WITHDRAWN
Last Update Posted:
2013-04-29
First Post:
2007-08-30
Brief Title:
SARS Survivor Evaluations
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Immune Responses Transmission and Nucleotide Polymorphisms in Families With SARS Virus Infections
Status:
WITHDRAWN
Status Verified Date:
2011-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to understand how severe acute respiratory syndrome SARS spreads within families if significant disease resulted and how the body responds to SARS The study will also explore the affects of SARS on genetics and the immune system the body system that fights disease Up to 1000 people residing in Beijing China may be involved in this study Adult survivors of SARS numbering 200 and their family members including children age 4 and up will be asked to participate in the study The study will recruit an additional 200 persons who will be matched with SARs survivors of similar age gender health status and housingwork location and recruited as comparators Blood will be taken from all volunteers and tested for the presence of SARS antibodies proteins made by the bodys immune system in response to something that can cause infection Health and clinichospital visit records may be reviewed
Detailed Description:
This study will investigate immune responses transmission and nucleotide polymorphisms in families with severe acute respiratory syndrome SARS virus infections Study objectives are to develop an immune response profile to SARS coronavirus SARS CoV among SARS survivors ascertain whether there was spread of SARS CoV within the family and whether significant disease resulted and determine whether 1 or more nucleotide polymorphisms relate to occurrence and severity of SARS CoV disease or immunologic responses Up to 1000 persons residing in Beijing China will participate in this study and will include the following groups 200 adult greater than or equal to18 years of age subjects previously experiencing SARS caused by SARS Coronavirus their householdfamily members including children ages 4 and up male or female and an additional 200 adults matched for characteristics age gender health status and housingwork location of the 200 SARS survivors As much as possible for DNA tests these controls will be persons involved in health care with a possible SARS exposure during the epidemic Blood will be obtained from all subjects and used for SARS CoV antibody assays Additional studies will be performed with blood specimens from selected subjects Tests for serum antibodies will be used to identify infected persons in each family For any who possess specific antibodies a review of their health and clinichospital visit records for the SARS epidemic period will be conducted to identify any illness its type and severity A control for interpretation can be illnesses during the study period in uninfected family members Data will be analyzed by age gender and health status of family members the severity of SARS illness in the index case and the time of return to the home environment The illness data will be obtained from medical records and not from subject memory To assess health status subjects for this study will have a chest x-ray performed and 15 mL of blood obtained for complete blood counts liver function to include ALT and creatinine For study purposes 30 to 100 mL of blood will be collected from SARS survivors and from 50 matched controls age gender and health status Illnesses from medical records will be characterized for severity and will include extent of x-ray changes need for oxygen therapy medical care in the intensive care unit and extent of leukocyte changes Microarray chips that contain human genes determining immune responses production of cytokines and chemokines and a number of other potential responses to illness have been constructed PureGene kits will be provided for isolation of DNA from blood specimens for testing for polymorphisms These analyses will be performed on the 200 SARS survivors the 200 matched controls and on family members The DNA samples will be shipped to laboratories at Baylor College of Medicine for analysis using the microarray chips
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None