Ignite Creation Date:
2024-05-05 @ 4:54 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00342524
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2006-06-19
Brief Title:
Collection of Convalescent SARS Plasma by Apheresis
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Collection of Convalescent SARS Plasma by Apheresis
Status:
COMPLETED
Status Verified Date:
2007-02-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 US 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 andor the US as well as any other place the disease recurs
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 US 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 andor the US as well as any other place the disease recurs
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 05-I-N192 | None | None | None |