Investigating Severe Acute Respiratory Syndrome (SARS)

Sponsor
National Institute of Allergy and Infectious Diseases (NIAID) (NIH)
Overall Status
Completed
CT.gov ID
NCT00066209
Collaborator
(none)
400
1
45.6
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Study Details

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Official Title:
    An Investigation of the Inflammatory Response in Severe Acute Respiratory Syndrome (SARS)
    Study Start Date :
    Aug 4, 2003
    Study Completion Date :
    May 24, 2007

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      N/A and Older
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      Yes
      • 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.

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 National Institutes of Health Clinical Center, 9000 Rockville Pike Bethesda Maryland United States 20892

      Sponsors and Collaborators

      • National Institute of Allergy and Infectious Diseases (NIAID)

      Investigators

      None specified.

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT00066209
      Other Study ID Numbers:
      • 030240
      • 03-I-0240
      First Posted:
      Aug 6, 2003
      Last Update Posted:
      Jul 2, 2017
      Last Verified:
      May 24, 2007

      Study Results

      No Results Posted as of Jul 2, 2017