Severe Acute Respiratory SyndromeNCT00073086
Evaluation and Treatment of Severe Acute Respiratory Syndrome (SARS)
An observational study of Severe Acute Respiratory Syndrome, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
This study will evaluate and treat people with SARS, a new type of pneumonia (lung infection) originating in China. SARS is caused by a new virus that is easily transmitted from person to person. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Acute Respiratory Syndrome
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Nov 2003to 27 Dec 2010
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Probable SARS Inclusion Criteria:
- One of the following:
- Travel within 10 days of onset of symptoms to an area with documented or suspected community transmission of SARS (as continually defined by the WHO and/or CDC)
- OR
- Close contact within 10 days of onset of symptoms with a person known to be a suspect SARS case.
- Close contact is defined as having cared for, having lived with, or having direct contact with respiratory secretions and/or body fluids of a patient known to be suspect SARS case.
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- AND
- Measured temperature greater than 100.4(Degree)F (greater than 38(Degree) C)
- AND
- Evidence of an acute respiratory illness as manifested by one of the following:
- Cough: shortness of breath, difficulty breathing, hypoxia
- AND
- Radiographic evidence of pneumonia or ARDS
- AND
- Clinically stable for transfer to the Clinical Center
- AND
- The ability to understand and willingness to sign a written consent form or in cases of 1) a minor, 2) temporary incompetence due to severe illness, or 3) permanent incompetence due to a chronic condition, informed consent may be signed by a legal guardian or appropriate proxy.
- Suspected SARS Inclusion Criteria:
- One of the following:
- Travel within 14 days of onset of symptoms to an area with documented or suspected community transmission of SARS (as continually defined by the WHO and/or CDC)
- OR
- Close contact within 14 days of onset of symptoms with either a person with a respiratory illness who traveled to a SARS area or a person known to be a suspect SARS case.
- Close contact is defined as one of the following:
- Close contact is defined as having cared for, having lived with, or having direct contact with respiratory secretions and/or body fluids of a patient known to be suspect SARS case.
- Other contact of sufficient proximity and duration that transmission of the causative agent of SARS may have occurred. This will be determined on an individual basis by the PI or an associate investigator.
- AND
- One of the following:
- Measured temperature greater than 100.4(Degree)F (greater than 38(Degree) C)
- Evidence of an acute respiratory illness as manifest by one of the following:
- cough, shortness of breath, difficulty breathing, hypoxia, radiographic findings of either pneumonia or acute respiratory distress syndrome
- AND
- Clinically stable for transfer to the Clinical Center
- AND
- The ability to understand and willingness to sign a written consent form or in cases of 1) a minor, 2) temporary incompetence due to severe illness, or 3) permanent incompetence due to a chronic condition, informed consent may be signed by a legal guardian or appropriate proxy.
- Close Contact Inclusion Criteria:
- Close contact with a patient suspected to have SARS within 10 days of the time of enrollment.
- Close contact is defined as one of the following:
- having cared for, having lived with, or having direct contact with respiratory secretions and/or body fluids of a patient suspected or known to have SARS.
- Other contact of sufficient proximity and duration that transmission of the causative agent of SARS may have occurred. This will be determined on an individual basis by the PI or an associate investigator.
- AND
- The ability to understand and willingness to sign a written consent form or in cases of 1) a minor, 2) temporary incompetence due to severe illness, or 3) permanent incompetence due to a chronic condition, informed consent signed by a legal guardian or appropriate proxy.
- Recovered SARS Inclusion Criteria
- 1. Within the last six months, had one of the following:
- an acute illness characterized by (all of the following):
- Fever greater than 100.4 (if measured)
- AND
- History of an acute respiratory illness as manifested by one of the following:
- cough, shortness of breath, difficulty breathing, hypoxia
- AND
- The illness occurred within 10days of travel to an area with documented or suspected community transmission of SARS (as continually defined by the WHO and/or CDC)
- OR
- Had close contact within 10 days of onset of symptoms with either a person with a respiratory illness who traveled to a SARS area or a person known to be a suspected SARS case.
- Close contact is defined as one of the following:
- Close contact is defined as having cared for, having lived with, or having direct contact with respiratory secretions and/or body fluids of a patient known to be suspect SARS case.
- Other contact of sufficient proximity and duration that transmission of the causative agent of SARS may have occurred. This will be determined on an individual basis by the PI or an associate investigator.
- OR
- an acute respiratory illness with the laboratory confirmation of SARS
- AND
- 2. The ability to understand and willingness to sign a written consent form or in cases of 1) a minor, 2) temporary incompetence due to severe illness, or 3) permanent incompetence due to a chronic condition, informed consent signed by a legal guardian or appropriate proxy.
- Health Care Worker Surveillance Inclusion Criteria
- NIH health care worker that is anticipated to be involved with the clinical care of SARS patients
- The ability to understand and willingness to sign a written consent form.
- A health care worker is defined as anyone involved with patient care or patient contact.
- Note: this group may be enrolled prior to SARS patients hospitalized at the clinical center.
Who cannot join
- Probable SARS Exclusion Criteria:
- Age less than 18 years old.
- Known pregnancy or positive urine/blood pregnancy test.
- Suspected SARS Exclusion Criteria:
- Meets inclusion criteria for SARS
- Age less than 18 years old.
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- Known pregnancy or positive urine/blood pregnancy test.
- Close Contact Exclusion Criteria:
- Less than 10 kg.
- Subjects who meet criteria for SARS or Suspected SARS
- Recovered SARS Exclusion Criteria
- Less than 10 kg.
- Temperature greater than 100.4 F (38.0 C) or symptoms of active respiratory illness
- Health Care Worker Surveillance Exclusion Criteria
- No exclusion criteria.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Clinical Evaluation and Management of Persons With Severe Acute Respiratory Syndrome (SARS)
This study will evaluate and treat people with SARS, a new type of pneumonia (lung infection) originating in China. SARS is caused by a new virus that is easily transmitted from person to person. This study will look at the course of the disease; determine how the virus affects the body and how the body fights the infection; and evaluate diagnostic tests to quickly identify the disease.
People 18 years of age and older with probable or suspected SARS may be eligible for this study. Close contacts of patients with SARS, patients who recovered from SARS, and NIH health care workers involved in the care of patients will also be enrolled. Patients with SARS who require hospitalization will be admitted to the NIH Clinical Center. Because SARS spreads easily, hospitalized patients will be in a room by themselves and will not be allowed any visitors. They will not leave their room except for tests, such as x-rays.
Read more
All participants will have a full medical examination, including a medical history, physical examination, and blood tests. In addition, the participants undergo various tests and procedures as follows:
- Probable and suspected SARS patients may be hospitalized or may be seen as outpatients. They are provided the treatment judged best for their disease, usually according to expressed or published recommendations. The best treatment for SARS is not yet known, and there have been no studies evaluating therapies. Outpatients are seen three times a week for 2 weeks, once a week for 4 more weeks, and then at 6 months. Patients have mouth and throat swabs taken three times a week for the first 2 weeks, then once a week for 4 more weeks. Blood is drawn three times a week for the first 2 weeks, then once at weeks 3, 4, and 6. If virus is still detectable after 6 weeks, nose washings and throat swabs are repeated until no virus is detected for 3 weeks in a row. In addition, patients provide urine and stool samples, have a chest x-ray and electrocardiogram, and undergo bronchoscopy and bronchial lavage. For the bronchoscopy, a bronchoscope (pencil-thin flexible tube) is passed into the large airways of the lung, allowing the physician to examine the airways. Cells and secretions from the airways are rinsed from the lung with salt water. A brush the size of a pencil tip is passed through the bronchoscope to scrape cells lining the airways and pieces of tissue are collected for analysis.
- Close contacts of patients are evaluated twice a week for 2 weeks, then once a week for 2 more weeks. Blood is drawn at the first visit and then at 1, 2, and 4 weeks. Mouth and throat swabs, nose washings, and sputum collections are done twice a week for 2 weeks, then once a week for 2 more weeks. Urine and stool samples are collected once a week for 4 weeks. If virus from the nose or throat is still detectable after 4 weeks, weekly nose washings and throat swabs continue until no virus is detected for 3 weeks in a row. Blood may also be drawn during the weekly visits.
- Recovered SARS patients provide blood, urine, and stool samples and have a mouth and throat swab and nose aspiration to see if the SARS virus is present. For the nasal aspiration, salt water is put in the nose and then suctioned out. Usually, these tests are done only once. If virus is detected, however, the nose washing, throat swabs and blood tests are repeated once a week until no virus is detected for 3 weeks in a row.
- Health care workers document their contact with patients, use of isolation procedures and equipment, and any unexpected events that occur during contact. They are evaluated for symptoms of infection and provide a blood sample once a month
Read the detailed description
Since mid February 2003, there have been reports of atypical pneumonias originating in China which have subsequently been termed the Severe Acute Respiratory Syndrome (SARS). SARS has subsequently spread to multiple countries including the United States, and is accompanied by a higher than anticipated morbidity and mortality. Because of world travel and the apparent easy transmissibility of this disease reported in other nations, the number of patients with SARS may continue to rise. The primary purpose of this protocol is to evaluate and treat persons with SARS. Other goals will be to characterize the clinical course of SARS by also evaluating close contacts of people with SARS, as well as those that have recovered from SARS. Additional goals of the protocol are to elucidate the pathophysiology of SARS, characterize the immune response during SARS, and evaluate diagnostic tests for the rapid identification of SARS in clinical specimens. Further knowledge about SARS may lead to effective forms of therapy and improve mortality from this disease.
- Conditions
- Severe Acute Respiratory Syndrome
- Keywords
- Coronavirus, Pneumonia, Asia, China, Severe Acut Respiratory Syndrome, SARS, Suspected SARS
- Medical subject headings
- Severe Acute Respiratory Syndrome, Coronavirus Infections, Pneumonia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2003 (estimated)
- Study start5 Nov 2003
- Study completion27 Dec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Severe Acute Respiratory SyndromeStudies 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
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00073086
- Sponsor's protocol ID
- 040030
- Other IDs
- 04-I-0030
- Status last verified
- 27 Dec 2010
- First submitted
- 14 Nov 2003
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Centers for Disease Control and Prevention (CDC). Update: Outbreak of severe acute respiratory syndrome--worldwide, 2003. MMWR Morb Mortal Wkly Rep. 2003 Mar 28;52(12):241-6, 248.
PubMed 12680518Gilbert BE, Knight V. Biochemistry and clinical applications of ribavirin. Antimicrob Agents Chemother. 1986 Aug;30(2):201-5. doi: 10.1128/AAC.30.2.201. No abstract available.
PubMed 2876677Stein DS, Creticos CM, Jackson GG, Bernstein JM, Hayden FG, Schiff GM, Bernstein DI. Oral ribavirin treatment of influenza A and B. Antimicrob Agents Chemother. 1987 Aug;31(8):1285-7. doi: 10.1128/AAC.31.8.1285.
PubMed 3307623
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation and Management of Persons With Severe Acute Respiratory Syndrome (SARS)
- ClinicalTrials.gov ID
- NCT00073086
- Acronym / sponsor ID
- 040030
- Conditions
- Severe Acute Respiratory Syndrome
- Keywords
- Coronavirus, Pneumonia, Asia, China, Severe Acut Respiratory Syndrome, SARS, Suspected SARS
- 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
- Study start
- 5 Nov 2003
- Study completion
- 27 Dec 2010
- First posted
- 17 Nov 2003 (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.
This study will evaluate and treat people with SARS, a new type of pneumonia (lung infection) originating in China. SARS is caused by a new virus that is easily transmitted from person to person. This study will look at the course of the disease; determine how the virus affects the body and how the body fights the infection; and evaluate diagnostic tests to quickly identify the disease.
People 18 years of age and older with probable or suspected SARS may be eligible for this study. Close contacts of patients with SARS, patients who recovered from SARS, and NIH health care workers involved in the care of patients will also be enrolled. Patients with SARS who require hospitalization will be admitted to the NIH Clinical Center. Because SARS spreads easily, hospitalized patients will be in a room by themselves and will not be allowed any visitors. They will not leave their room except for tests, such as x-rays.
All participants will have a full medical examination, including a medical history, physical examination, and blood tests. In addition, the participants undergo various tests and procedures as follows:
- Probable and suspected SARS patients may be hospitalized or may be seen as outpatients. They are provided the treatment judged best for their disease, usually according to expressed or published recommendations. The best treatment for SARS is not yet known, and there have been no studies evaluating therapies. Outpatients are seen three times a week for 2 weeks, once a week for 4 more weeks, and then at 6 months. Patients have mouth and throat swabs taken three times a week for the first 2 weeks, then once a week for 4 more weeks. Blood is drawn three times a week for the first 2 weeks, then once at weeks 3, 4, and 6. If virus is still detectable after 6 weeks, nose washings and throat swabs are repeated until no virus is detected for 3 weeks in a row. In addition, patients provide urine and stool samples, have a chest x-ray and electrocardiogram, and undergo bronchoscopy and bronchial lavage. For the bronchoscopy, a bronchoscope (pencil-thin flexible tube) is passed into the large airways of the lung, allowing the physician to examine the airways. Cells and secretions from the airways are rinsed from the lung with salt water. A brush the size of a pencil tip is passed through the bronchoscope to scrape cells lining the airways and pieces of tissue are collected for analysis.
- Close contacts of patients are evaluated twice a week for 2 weeks, then once a week for 2 more weeks. Blood is drawn at the first visit and then at 1, 2, and 4 weeks. Mouth and throat swabs, nose washings, and sputum collections are done twice a week for 2 weeks, then once a week for 2 more weeks. Urine and stool samples are collected once a week for 4 weeks. If virus from the nose or throat is still detectable after 4 weeks, weekly nose washings and throat swabs continue until no virus is detected for 3 weeks in a row. Blood may also be drawn during the weekly visits.
- Recovered SARS patients provide blood, urine, and stool samples and have a mouth and throat swab and nose aspiration to see if the SARS virus is present. For the nasal aspiration, salt water is put in the nose and then suctioned out. Usually, these tests are done only once. If virus is detected, however, the nose washing, throat swabs and blood tests are repeated once a week until no virus is detected for 3 weeks in a row.
- Health care workers document their contact with patients, use of isolation procedures and equipment, and any unexpected events that occur during contact. They are evaluated for symptoms of infection and provide a blood sample once a month
Detailed description
Since mid February 2003, there have been reports of atypical pneumonias originating in China which have subsequently been termed the Severe Acute Respiratory Syndrome (SARS). SARS has subsequently spread to multiple countries including the United States, and is accompanied by a higher than anticipated morbidity and mortality. Because of world travel and the apparent easy transmissibility of this disease reported in other nations, the number of patients with SARS may continue to rise. The primary purpose of this protocol is to evaluate and treat persons with SARS. Other goals will be to characterize the clinical course of SARS by also evaluating close contacts of people with SARS, as well as those that have recovered from SARS. Additional goals of the protocol are to elucidate the pathophysiology of SARS, characterize the immune response during SARS, and evaluate diagnostic tests for the rapid identification of SARS in clinical specimens. Further knowledge about SARS may lead to effective forms of therapy and improve mortality from this disease.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (64 listed)
- One of the following:
- Travel within 10 days of onset of symptoms to an area with documented or suspected community transmission of SARS (as continually defined by the WHO and/or CDC)
- OR
- Close contact within 10 days of onset of symptoms with a person known to be a suspect SARS case.
- Close contact is defined as having cared for, having lived with, or having direct contact with respiratory secretions and/or body fluids of a patient known to be suspect SARS case.
Key exclusion criteria (15 listed)
- Recovered SARS Exclusion Criteria
- Health Care Worker Surveillance Exclusion Criteria
- No exclusion criteria.
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
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Background: PubMed 12680518Centers for Disease Control and Prevention (CDC). Update: Outbreak of severe acute respiratory syndrome--worldwide, 2003. MMWR Morb Mortal Wkly Rep. 2003 Mar 28;52(12):241-6, 248.
- Background: PubMed 2876677Gilbert BE, Knight V. Biochemistry and clinical applications of ribavirin. Antimicrob Agents Chemother. 1986 Aug;30(2):201-5. doi: 10.1128/AAC.30.2.201. No abstract available.
- Background: PubMed 3307623Stein DS, Creticos CM, Jackson GG, Bernstein JM, Hayden FG, Schiff GM, Bernstein DI. Oral ribavirin treatment of influenza A and B. Antimicrob Agents Chemother. 1987 Aug;31(8):1285-7. doi: 10.1128/AAC.31.8.1285.
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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.
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 Severe Acute Respiratory Syndrome, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
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 64 inclusion and 15 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 2 Jul 2017. 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 United States. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00073086, which also lists 3 linked publications.
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 2 Jul 2017.