Investigating Severe Acute Respiratory Syndrome (SARS)

SARS Virus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00066209
• Other study ID #: 030240
• Secondary ID: 03-I-0240
• Status: Completed
• Phase: N/A
• First received: August 5, 2003
• Last updated: June 30, 2017
• Start date: August 4, 2003
• Est. completion date: May 24, 2007

Study information

• Verified date: May 24, 2007
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: May 24, 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

• 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.

Related Conditions & MeSH terms

• Coronavirus Infections
• SARS Virus
• Severe Acute Respiratory Syndrome

Locations

Country	Name	City	State
United States	National Institutes of Health Clinical Center, 9000 Rockville Pike	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States,