Clinical Trial Sponsors: National Institute of Allergy and Infectious Diseases (NIAID)

  Source:		NCT00523276

    		SARS Survivor Evaluations

			First Update August 30, 2007
			Last Update April 25, 2013

			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 housing/work location, and recruited as
			comparators. Blood will be taken from all
			volunteers and tested for the presence of
			SARS antibodies (proteins made by the body's
			immune system in response to something that
			can cause infection). Health and clinic/hospital
			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
			1,000 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 household/family members,
			including children ages 4 and up (male or
			female); and an additional 200 adults matched
			for characteristics (age, gender, health status
			and housing/work 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 clinic/hospital 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.

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