Investigating Severe Acute Respiratory Syndrome (SARS)

An Investigation of the Inflammatory Response in Severe Acute Respiratory Syndrome (SARS)

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.

Study Overview

• Status: Completed
• Conditions: SARS Virus

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 Type: Observational
• Enrollment: 400

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Bethesda, Maryland, United States, 20892
      • National Institutes of Health Clinical Center, 9000 Rockville Pike

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

• 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.

Study Plan

How is the study designed?

Collaborators and Investigators

• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Study record dates

Study Major Dates

• Study Start: August 4, 2003
• Study Completion: May 24, 2007

Study Registration Dates

• First Submitted: August 5, 2003
• First Submitted That Met QC Criteria: August 5, 2003
• First Posted (Estimate): August 6, 2003

Study Record Updates

• Last Update Posted (Actual): July 2, 2017
• Last Update Submitted That Met QC Criteria: June 30, 2017
• Last Verified: May 24, 2007

More Information

Terms related to this study

• Keywords: Inflammation; HV; Healthy Volunteer; Coronavirus; Immunity; Cytokine; Interferon; Severe Acute Respiratory Syndrome; SARS
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Severe Acute Respiratory Syndrome
• Other Study ID Numbers: 030240; 03-I-0240