SARS, Severe Acute Respiratory Syndrome
Conditions
Keywords
IVIG, Plasmapheresis, Blood Collection, Immune Globulin, Severe Acute Respiratory Syndrome, SARS
Brief summary
The purpose of this study is to collect plasma by apheresis from patients who have recovered from Severe Acute Respiratory Syndrome (SARS). This plasma will be processed into a SARS-antibody enriched intravenous immune globulin (IVIG) product. This product will then be available for use in a clinical trial if a SARS epidemic recurs. Potentially eligible participants are people between 18 and 56 years of age who have recovered from SARS. Potential participants will undergo three sequential screenings to determine their eligibility for this study. Eligible participants will then be scheduled for plasmapheresis. After apheresis, additional testing will be performed on a sample of the source plasma. Once the sample has been tested and cleared, the source plasma will be shipped to the United States to the storage facility and finally to the site of manufacturing of the IVIG product. Participants may donate plasma again after 14 days. The study will not have a direct benefit for participants. However, participation may help develop a treatment that could be useful to other people who become infected with SARS.
Detailed description
Beginning in February 2003, there was an outbreak with a novel coronavirus causing an atypical pneumonia, subsequently referred to as Severe Acute Respiratory Syndrome (SARS). This syndrome is associated with a high mortality rate and has no proven treatment. There is, however, some evidence that treatment with convalescent plasma was beneficial. The primary purpose of this protocol is to collect plasma by apheresis from patients that recovered from SARS, and process this plasma into a high titer anti-SARS intravenous immune globulin (IVIG). This will be a collaboration between the National Institute of Allergy and Infectious Diseases and the Chinese University of Hong Kong. Cangene Corporation has been contracted to manufacture the collected plasma in the United States (U.S.) into an IVIG product, which can then be used for pre-clinical efficacy studies under an IND in a clinical trial if SARS recurs. It is intended that the treatment trial would be conducted in Hong Kong and/or the U.S., as well as any other place the disease recurs.
Interventions
None listed
Sponsors
National Institute of Allergy and Infectious Diseases (NIAID)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* INCLUSION CRITERIA: RECOVERED SARS SCREENING - INCLUSION CRITERIA (ALL OF THE FOLLOWING): 1. Clinical diagnosis of SARS occurring greater than or equal to 3 months prior to screening. (objective documentation of SARS is not necessary) 2. The ability to understand and willingness to sign a written consent form and comply with study requirements and procedures. SARS APHERESIS SCREENING - INCLUSION CRITERIA (ALL OF THE FOLLOWING): 1. SARS Ab level greater than or equal to 1:80 2. Adequate clinical parameters (must meet all of the criteria below): 1. Afebrile (temperature less than 38 degrees C) 2. Systolic blood pressure greater than 100 and less than 160 mmHg 3. Diastolic blood pressure greater than 50 and less than 100 mmHg 4. Heart rate between 50-100 beats/minute 5. Weight greater than or equal to 110 pounds (50kg) 3. Adequate laboratory parameters (must meet all of the criteria below): 1. Hemoglobin greater than or equal to 12.5 g/dL for females or 13 grams/dL for males 2. HCT greater than or equal to 38% 3. Platelets greater than or equal to 150,000 x 10(3)/microL 4. Total serum protein greater than or equal to 6.0 grams/100 milliliters of blood 5. ALT less than 1.5 Upper limit of normal 6. Quantitative immune globulin levels (all of the following): * Ig A greater than or equal to 90 mg/dL * Ig G greater than or equal to 650 mg/dL * Ig M greater than or equal to 35 mg/dL 4. Negative tests for blood borne pathogens (must meet all of the criteria below): 1. Human Immunodeficiency Virus 1/2 Antibody (Anti-HIV1/2) negative 2. Hepatitis B virus surface antigen (HBsAg) negative 3. Hepatitis C virus antibody (anti-HCV) negative 4. RPR non-reactive 5. HTLV antibody 5. Adequate peripheral venous access for plasmapheresis (as judged by the examiner) DAY OF DONATION SCREENING - INCLUSION CRITERIA: 1. Afebrile (temperature less than 38 degrees C) 2. Systolic blood pressure greater than 100 and less than 160 mmHg 3. Diastolic blood pressure greater than 50 and less than 100 mmHg 4. Heart rate between 50-100 beats/minute 5. Blood hemoglobin level of greater than or equal to 12.5 grams/dL for females or 13 grams/dL for males 6. Total serum protein greater than or equal to 6.0 grams/100 milliliters of blood 7. Weight greater than or equal to 110 pounds (50kg) 8. RPR performed in the 4 months prior to the day of donation and non-reactive. 9. AST performed in the 4 months prior to the day of donation less than 1.5 upper limit of normal. 10. SARS antibody performed in the 4 months prior to the day of donation, and Ab titer greater than or equal to 1:80 11. Quantitative immune globulin levels performed in the 4 months prior to the day of donation (and all of the following): * Ig A greater than or equal to 90 mg/dL * Ig G greater than or equal to 650 mg/dL * Ig M greater than or equal to 35 mg/dL
Exclusion criteria
RECOVERED SARS SCREENING -
Countries
China
Outcome results
None listed