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.
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
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.
- Conditions
- Coronavirus (SARS-CoV)
- 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 group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- First posted31 Aug 2007 (estimated)
- Primary completionJun 2011 (estimated)
- Study completionJun 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronavirus (SARS-CoV)Studies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The 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
- Observational model
- Family based
- Time perspective
- Cross-sectional
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
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
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immune Responses, Transmission and Nucleotide Polymorphisms in Families With SARS Virus Infections
- ClinicalTrials.gov ID
- NCT00523276
- Acronym / sponsor ID
- 06-0048
- Conditions
- Coronavirus (SARS-CoV)
- Keywords
- Severe acute respiratory syndrome, SARS, China
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Primary completion
- Jun 2011 (estimated)
- Study completion
- Jun 2011 (estimated)
- First posted
- 31 Aug 2007 (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.
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.
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.
Study design
- Observational model
- Family based
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 4 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adult (> 18 yo) SARS survivors and family members. Adult matched controls
Key inclusion criteria (7 listed)
- 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 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.
Key exclusion criteria (6 listed)
- Presence of an acute illness.
- Hemoglobin below normal range for gender and age.
- Current pregnancy or possible pregnancy (by history).
- 1. Current pregnancy or possible pregnancy (by history).
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
Positive serology, SARS CoV
Time frame: at time of assay
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
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.