NCT00173563

Brief Summary

Severe acute respiratory syndrome (SARS) is a new emerging infectious disease. Its pathogen is a newly discovered coronavirus (SARS-CoV). The clinical course can be classified to 3 stages: viral replication phase, hyperimmune reactive phase, and pulmonary destruction phase. Human monocyte plays a critical role in the initiation of immune response in defending the intracellular pathogens (eg viruses). Monocytes can engulf viruses and present the viral antigens in the major histocompatibility (MHC) molecule to the cell surface to initiate T lymphocyte response. Monocytes also secrete various cytokines to modulate immune response. SARS-CoV is a mutant of animal virus to cause human disease and is able to cause unusual severe respiratory illness. It is suggested the unusual severe disease is due to the intense immune reaction. The investigators will harvest human monocytes from healthy adult and children blood donors. Monocytes would be cultured and infected by SARS-CoV. The change of viral load is monitored after infection. Cytokines secreted by monocytes after infection are also measured. The difference of monocyte cytokine secretion is compared between adults and children. The study is to verify the SARS-CoV infectivity of human monocytes and prove the unusual severity caused by SARS-CoV is related to viral-induced dysregulation of cytokine responses. The results may also clarify why adults tend to have a more severe illness compared with children.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2005

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

January 1, 2005

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2005

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
Last Updated

December 3, 2007

Status Verified

August 1, 2005

First QC Date

September 12, 2005

Last Update Submit

November 30, 2007

Conditions

Healthy

Keywords

Immunology

Eligibility Criteria

Age2 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Healthy adults aged 20 to 50 years old
  • Healthy children aged 2 to 5 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

Study Officials

  • Luan-Yin Chang, MD, PhD

    Department of pediatrics, National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 15, 2005

Study Start

January 1, 2005

Study Completion

September 1, 2005

Last Updated

December 3, 2007

Record last verified: 2005-08

Locations

TW(1)