HealthyNCT00173563
Induction of Cytokines in Human Monocytes by SARS-CoV in Adults and Children
An observational study of Healthy, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 10 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2005to Sep 2005
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 50 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Healthy adults aged 20 to 50 years old
- Healthy children aged 2 to 5 years old
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100
Luan-Yin Chang, MD, PhD, 886-2-23123456 ext. 3245, Ly7077@tpts6.seed.net.tw
Pei-Lan Shao, MD, 886-2-23123456 ext. 2394, shaopl@ha.mc.ntu.edu.tw
About this study
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.
- Conditions
- Healthy
- Keywords
- Immunology
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startJan 2005
- Study completionSep 2005 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Investigators
- Luan-Yin Chang, MD, PhD, Principal investigator, Department of pediatrics, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00173563
- Sponsor's protocol ID
- 9461700731
- Other IDs
- NSC92-2751-B-002-026-Y
- Status last verified
- Aug 2005
- First submitted
- 12 Sep 2005
- Last updated
- 3 Dec 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Induction of Cytokines in Human Monocytes by SARS-CoV in Adults and Children
- ClinicalTrials.gov ID
- NCT00173563
- Acronym / sponsor ID
- 9461700731
- Conditions
- Healthy
- Keywords
- Immunology
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Study start
- Jan 2005
- Study completion
- Sep 2005 (estimated)
- First posted
- 15 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 2 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Healthy adults aged 20 to 50 years old
- Healthy children aged 2 to 5 years old
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luan-Yin Chang, MD, PhD principal investigator
Department of pediatrics, National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Dec 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2007.