Investigating Severe Acute Respiratory Syndrome (SARS) - Tabular View

Tracking Information
First Received Date ^ICMJE	August 5, 2003
Last Updated Date	March 5, 2008
Start Date ^ICMJE	August 2003
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00066209 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Investigating Severe Acute Respiratory Syndrome (SARS)
Official Title ^ICMJE	An Investigation of the Inflammatory Response in Severe Acute Respiratory Syndrome (SARS)
Brief Summary	Severe Acute Respiratory Syndrome (SARS) is a newly recognized illness that can be fatal. The purpose of this study is to better understand SARS by collecting samples of blood and other body fluids of people who have been exposed to SARS or who are suspected to have the illness. Up to 300 volunteers aged 18 years or older will be enrolled in this study. Participants will donate blood samples and, if appropriate, samples of fluid from the lungs, nose, or throat. Researchers will test these samples for proteins that control or mediate inflammatory or immune responses. The patterns of these proteins will reveal how SARS affects the body and the efforts the body makes to fight off the infection.
Detailed Description	Severe acute respiratory syndrome (SARS) is a newly recognized illness associated with substantial mobidity and mortality. Patients develop fever followed by rapidly progressive and even fatal respiratory disease. SARS is associated with infection with a novel coronavirus. The evaluation of the inflammatory responses evoked by SARS may yield information regarding its pathogenesis and help with patient management. This protocol, then, merely aims to study disease pathogenesis and natural history, by studying samples and data that are collected by outside physicians or physicians at the Clinical Center and sent for evaluation of the inflammatory response.
Study Phase
Study Type ^ICMJE	Observational
Study Design ^ICMJE
Condition ^ICMJE	SARS Virus
Intervention ^ICMJE
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	400
Completion Date	May 2007
Primary Completion Date
Eligibility Criteria ^ICMJE	INCLUSION CRITERIA - CASES: Patients fulfilling the CDC case definition or WHO definition for suspected or probable SARS. Newly identified patients found to have recovered from SARS can also be enrolled. EXCLUSION CRITERIA - CASES: Patients diagnosed with alternative illnesses as the cause of the symptoms. INCLUSION CRITERIA - HEALTHY VOLUNTEERS: For the purpose of this study, a healthy volunteer is defined as a healthy male or female, age 18 and above. Volunteers will be excluded if they have a pre-existing or concurrent serious chronic medical or psychiatric illness. Chronic medication use will be evaluated on a case-by-case basis. They will also be excluded if they have received an investigational drug in the past 3 months.
Gender	Both
Ages
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00066209
Responsible Party
Study ID Numbers ^ICMJE	030240, 03-I-0240
Study Sponsor ^ICMJE	National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	National Institutes of Health Clinical Center (CC)
Verification Date	May 2007
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP