NCT00523276

Brief Summary

The purpose of this study is to understand how severe acute respiratory syndrome (SARS) spreads within families, if significant disease resulted, and how the body responds to SARS. The study will also explore the affects of SARS on genetics and the immune system (the body system that fights disease). Up to 1000 people residing in Beijing, China may be involved in this study. Adult survivors of SARS (numbering 200) and their family members including children age 4 and up will be asked to participate in the study. The study will recruit an additional 200 persons, who will be matched with SARs survivors of similar age, gender, health status, and housing/work location, and recruited as comparators. Blood will be taken from all volunteers and tested for the presence of SARS antibodies (proteins made by the body's immune system in response to something that can cause infection). Health and clinic/hospital visit records may be reviewed.

Trial Health

35
At Risk

Trial Health Score

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

Geographic Reach
1 country

2 active sites

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 30, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 31, 2007

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

April 29, 2013

Status Verified

April 1, 2011

First QC Date

August 30, 2007

Last Update Submit

April 25, 2013

Conditions

Keywords

Severe acute respiratory syndrome, SARS, China

Outcome Measures

Primary Outcomes (1)

  • Positive serology, SARS CoV

    at time of assay

Study Arms (3)

HCWs

Who may/may not have contact with SARS patients

Family/close contacts

No illness but household/close contact

SARS subjects

Diagnosed with active disease

Eligibility Criteria

Age4 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult (\> 18 yo) SARS survivors and family members. Adult matched controls

You may qualify if:

  • Severe Acute Respiratory Syndrome (SARS) Survivors and Controls:
  • An adult (\>= 18 years of age) proven in hospital/laboratory records to have had SARS as defined by the World Health Organization
  • A control matched for age, gender and health status similar to a SARS survivor and with a possible SARS exposure (healthcare personnel).
  • Granting informed consent
  • Family Members of SARS Survivors:
  • Family members currently age 4 or older who were living in a household with the SARS survivor study case at the time of SARS occurrence.
  • Informed consent granted by subject or parent if child is less than 18 years old.

You may not qualify if:

  • Severe Acute Respiratory Syndrome (SARS) Survivors and Controls:
  • Presence of an acute illness.
  • Hemoglobin below normal range for gender and age.
  • Current pregnancy or possible pregnancy (by history).
  • Family Members of SARS Survivors:
  • \. Current pregnancy or possible pregnancy (by history).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Beijing Ditan Hospital

Beijing, Beijing Municipality, 100011, China

Location

Beijing You'An Hospital

Beijing, Beijing Municipality, 100069, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Sera, PBMCs

MeSH Terms

Conditions

Coronavirus InfectionsSevere Acute Respiratory Syndrome

Condition Hierarchy (Ancestors)

Coronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus DiseasesInfectionsRespiratory Tract InfectionsRespiratory Tract Diseases
0

Study Design

Study Type
observational
Observational Model
FAMILY BASED
Time Perspective
CROSS SECTIONAL
Sponsor Type
NIH

Study Record Dates

First Submitted

August 30, 2007

First Posted

August 31, 2007

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

April 29, 2013

Record last verified: 2011-04

Locations