SARS Clinical Trial - Collection of Convalescent SARS Plasma by Apheresis

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Coronavirus Infections
SARS
Severe Acute Respiratory Syndrome

Clinical Trial Details

NCT number	NCT00342524
Study type	Observational
Source	National Institutes of Health Clinical Center (CC)
Contact
Status	Completed
Phase	N/A
Start date	July 6, 2005
Completion date	February 8, 2007

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.