Clinical Trials Logo

Clinical 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. 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


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT00073086
Study type Observational
Source National Institutes of Health Clinical Center (CC)
Contact
Status Withdrawn
Phase N/A
Start date November 5, 2003
Completion date December 27, 2010

See also
  Status Clinical Trial Phase
Completed NCT04542915 - COVID-19-Related Health and Practices Among Dental Hygienists
Completed NCT04515147 - A Dose-Confirmation Study to Evaluate the Safety, Reactogenicity and Immunogenicity of Vaccine CVnCoV in Healthy Adults for COVID-19 Phase 2
Recruiting NCT04480333 - Safety, Tolerability and Pharmacokinetics of Inhaled Nanoparticle Formulation of Remdesivir (GS-5734) and NA-831 Phase 1
Completed NCT04402957 - LSALT Peptide vs. Placebo to Prevent ARDS and Acute Kidney Injury in Patients Infected With SARS-CoV-2 (COVID-19) Phase 2
Withdrawn NCT04838847 - A Study to Evaluate the Immunogenicity and Safety of the SARS-CoV-2 mRNA Vaccine CVnCoV in Elderly Adults Compared to Younger Adults for COVID-19 Phase 3
Not yet recruiting NCT04386070 - Preventing Pulmonary Complications in Surgical Patients at Risk of COVID-19 Phase 3
Active, not recruiting NCT04527432 - COVID-19 Health Professional Impact Study N/A
Completed NCT00215826 - Study of Alferon® LDO (Low Dose Oral) in Normal Volunteers Phase 2
Completed NCT04366934 - Study of the Pathogenesis of Olfactory Disorders in COVID-19
Completed NCT04376684 - Investigating Otilimab in Patients With Severe Pulmonary COVID-19 Related Disease Phase 2
Completed NCT04402060 - A Study of APL-9 in Adults With Mild to Moderate ARDS Due to COVID-19 Phase 1/Phase 2
Completed NCT04395144 - COVid-19: Awake Proning and High-flow Nasal Cannula in respiratorY DistrEss N/A
Completed NCT04357730 - Fibrinolytic Therapy to Treat ARDS in the Setting of COVID-19 Infection Phase 2
Completed NCT04425213 - Obesity and Mortality of Critically Ill Patients With COVID-19
Completed NCT04425863 - Ivermectin, Aspirin, Dexamethasone and Enoxaparin as Treatment of Covid 19
Completed NCT06287554 - Effect of Early Implementation of Prone Positioning
Completed NCT04328129 - Household Transmission Investigation Study for COVID-19 in Tropical Regions N/A
Completed NCT04602351 - Communication in ICU During COVID-19
Completed NCT03225807 - Implementation of Lung Protective Ventilation in Patients With Acute Respiratory Failure
Recruiting NCT04381819 - Norwegian SARS-CoV-2 Study - Virological, Clinical and Immunological Characterisation of COVID-19