Back to resultsInvestigating Severe Acute Respiratory Syndrome (SARS)
Primary Purpose
SARS Virus
Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
About this trial
This is an observational trial for SARS Virus focused on measuring Inflammation, Coronavirus, Immunity, Interferon, Cytokine, Severe Acute Respiratory Syndrome, SARS, Healthy Volunteer, HV
Eligibility Criteria
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.
Sites / Locations
- National Institutes of Health Clinical Center, 9000 Rockville Pike
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00066209
First Posted
August 5, 2003
Last Updated
June 30, 2017
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
1. Study Identification
Unique Protocol Identification Number
NCT00066209
Brief Title
Investigating Severe Acute Respiratory Syndrome (SARS)
Official Title
An Investigation of the Inflammatory Response in Severe Acute Respiratory Syndrome (SARS)
Study Type
Observational
2. Study Status
Record Verification Date
May 24, 2007
Overall Recruitment Status
Completed
Study Start Date
August 4, 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 24, 2007 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
SARS Virus
Keywords
Inflammation, Coronavirus, Immunity, Interferon, Cytokine, Severe Acute Respiratory Syndrome, SARS, Healthy Volunteer, HV
7. Study Design
Enrollment
400 (false)
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
National Institutes of Health Clinical Center, 9000 Rockville Pike
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Investigating Severe Acute Respiratory Syndrome (SARS)
We'll reach out to this number within 24 hrs