Investigating Severe Acute Respiratory Syndrome (SARS)

June 30, 2017 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

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

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 030240
  • 03-I-0240

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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