NCT00066209

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2003

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 4, 2003

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

August 5, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 6, 2003

Completed
3.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 24, 2007

Completed
Last Updated

July 2, 2017

Status Verified

May 24, 2007

First QC Date

August 5, 2003

Last Update Submit

June 30, 2017

Conditions

Keywords

InflammationCoronavirusImmunityInterferonCytokineSevere Acute Respiratory SyndromeSARSHealthy VolunteerHV

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Patients diagnosed with alternative illnesses as the cause of the symptoms.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

MeSH Terms

Conditions

Severe Acute Respiratory SyndromeInflammationCoronavirus Infections

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

August 5, 2003

First Posted

August 6, 2003

Study Start

August 4, 2003

Study Completion

May 24, 2007

Last Updated

July 2, 2017

Record last verified: 2007-05-24

Locations