Investigating Severe Acute Respiratory Syndrome (SARS)

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00066209
First received: August 5, 2003
Last updated: March 5, 2008
Last verified: May 2007
  Purpose

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
SARS Virus

Study Type: Observational
Official Title: An Investigation of the Inflammatory Response in Severe Acute Respiratory Syndrome (SARS)

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 400
Study Start Date: August 2003
Estimated Study Completion Date: May 2007
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00066209

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00066209     History of Changes
Other Study ID Numbers: 030240, 03-I-0240
Study First Received: August 5, 2003
Last Updated: March 5, 2008
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Inflammation
Coronavirus
Immunity
Interferon
Cytokine
Severe Acute Respiratory Syndrome
SARS
Healthy Volunteer
HV

Additional relevant MeSH terms:
Severe Acute Respiratory Syndrome
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 21, 2014