![]() |
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
---|---|
Information provided by: | National Institutes of Health Clinical Center (CC) |
ClinicalTrials.gov Identifier: | NCT00342524 |
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.
Condition |
---|
Severe Acute Respiratory Syndrome SARS |
Study Type: | Observational |
Official Title: | Collection of Convalescent SARS Plasma by Apheresis |
Study Start Date: | July 2005 |
Estimated Study Completion Date: | February 2007 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
RECOVERED SARS SCREENING - INCLUSION CRITERIA (ALL OF THE FOLLOWING):
SARS APHERESIS SCREENING - INCLUSION CRITERIA (ALL OF THE FOLLOWING):
Adequate clinical parameters (must meet all of the criteria below):
Adequate laboratory parameters (must meet all of the criteria below):
Quantitative immune globulin levels (all of the following):
Negative tests for blood borne pathogens (must meet all of the criteria below):
DAY OF DONATION SCREENING - INCLUSION CRITERIA:
Quantitative immune globulin levels performed in the 4 months prior to the day of donation (and all of the following):
EXCLUSION CRITERIA:
RECOVERED SARS SCREENING - EXCLUSION CRITERIA:
Within the last week has:
Within the last 3 weeks has:
Within the last 4 weeks has:
Within the last 6 weeks has:
Within the last 8 weeks:
Within the last 3 months has:
Within the last 6 months has had:
Within the last 12 months has:
Within the last 12 months has had sexual contact with (any of the following):
Within the last 2 years has:
Within the last 3 years:
History of cancer that meets any one of the following criteria:
Medication history that includes any of the following:
Has ever had (any of the following)
SARS APHERESIS SCREENING - EXCLUSION CRITERIA:
1. Positive urine pregnancy test.
DAY OF DONATION SCREENING - EXCLUSION CRITERIA:
In the opinion of the interviewer, a donor that: (either of the following)
Study ID Numbers: | 999905192, 05-I-N192 |
Study First Received: | June 19, 2006 |
Last Updated: | March 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00342524 History of Changes |
Health Authority: | United States: Federal Government |
IVIG Plasmapheresis Blood Collection Immune Globulin |
Severe Acute Respiratory Syndrome Severe Acute Respiratory Syndrome SARS |
Virus Diseases Severe Acute Respiratory Syndrome Antibodies |
Respiratory Tract Diseases Respiratory Tract Infections Immunoglobulins |
Virus Diseases Severe Acute Respiratory Syndrome RNA Virus Infections Nidovirales Infections Coronavirus Infections Pathologic Processes |
Disease Respiratory Tract Diseases Respiratory Tract Infections Syndrome Coronaviridae Infections |