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Coronavirus (SARS-CoV)NCT00523276

SARS Survivor Evaluations

An observational study of Coronavirus (SARS-CoV), run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites in China.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 4 years and olderHealthy volunteers can take part
Conditions the study is for
Coronavirus (SARS-CoV)
How many people
0 participants
Where
2 sitesChina
Study dates
Start not givento Jun 2011
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 4 years and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Study population: Adult (> 18 yo) SARS survivors and family members. Adult matched controls

Who may be able to join

  • 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.

Who cannot join

  • 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:
  • 1. Current pregnancy or possible pregnancy (by history).

Trial locations and contacts

2 sites in 1 country.

China2 sites
  • Beijing Ditan Hospital

    Beijing, Beijing Municipality, 100011

  • Beijing You'An Hospital

    Beijing, Beijing Municipality, 100069

Other trials in China

About this study

Official title: Immune Responses, Transmission and Nucleotide Polymorphisms in Families With SARS Virus Infections

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.

Read the detailed description

This study will investigate immune responses, transmission and nucleotide polymorphisms in families with severe acute respiratory syndrome (SARS) virus infections. Study objectives are to: develop an immune response profile to SARS coronavirus (SARS CoV) among SARS survivors; ascertain whether there was spread of SARS CoV within the family and whether significant disease resulted; and determine whether 1 or more nucleotide polymorphisms relate to occurrence and severity of SARS CoV disease or immunologic responses. Up to 1,000 persons residing in Beijing, China, will participate in this study and will include the following groups: 200 adult (greater than or equal to18 years of age) subjects, previously experiencing SARS caused by SARS Coronavirus; their household/family members, including children ages 4 and up (male or female); and an additional 200 adults matched for characteristics (age, gender, health status and housing/work location) of the 200 SARS survivors. As much as possible (for DNA tests), these controls will be persons involved in health care with a possible SARS exposure during the epidemic. Blood will be obtained from all subjects and used for SARS CoV antibody assays. Additional studies will be performed with blood specimens from selected subjects. Tests for serum antibodies will be used to identify infected persons in each family. For any who possess specific antibodies, a review of their health and clinic/hospital visit records for the SARS epidemic period will be conducted to identify any illness, its type and severity. A control for interpretation can be illnesses during the study period in uninfected family members. Data will be analyzed by age, gender, and health status of family members, the severity of SARS illness in the index case and the time of return to the home environment. The illness data will be obtained from medical records and not from subject memory. To assess health status, subjects for this study will have a chest x-ray performed and 15 mL of blood obtained for complete blood counts, liver function, to include ALT, and creatinine. For study purposes, 30 to 100 mL of blood will be collected from SARS survivors and from 50 matched controls (age, gender and health status). Illnesses from medical records will be characterized for severity and will include extent of x-ray changes, need for oxygen therapy, medical care in the intensive care unit and extent of leukocyte changes. Microarray chips that contain human genes determining immune responses, production of cytokines and chemokines and a number of other potential responses to illness have been constructed. PureGene kits will be provided for isolation of DNA from blood specimens for testing for polymorphisms. These analyses will be performed on the 200 SARS survivors, the 200 matched controls and on family members. The DNA samples will be shipped to laboratories at Baylor College of Medicine for analysis using the microarray chips.

Keywords
Severe acute respiratory syndrome, SARS, China
Medical subject headings
Coronavirus Infections, Severe Acute Respiratory Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00523276
Study groupRoleWhat they receive
HCWsWho may/may not have contact with SARS patients
Family/close contactsNo illness but household/close contact
SARS subjectsDiagnosed with active disease

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Positive serology, SARS CoV

    Measured: at time of assay

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Aug 2007 (estimated)
  2. Primary completionJun 2011 (estimated)
  3. Study completionJun 2011 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Family based
Time perspective
Cross-sectional
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00523276
Sponsor's protocol ID
06-0048
Status last verified
Apr 2011
First submitted
30 Aug 2007
Last updated
29 Apr 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

An observational study of Coronavirus (SARS-CoV), run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites in China.

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 7 inclusion and 6 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: withdrawn, as of the sponsor's last update on 29 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. 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?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Positive serology, SARS CoV (time frame: at time of assay). It is what the study was designed to measure, not a finding.

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 29 Apr 2013.

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