Collection of Convalescent SARS Plasma by Apheresis

NCT00342524 | Completed

• 2 other identifiers: 99990519205-I-N192
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Severe Acute Respiratory Syndrome; SARS

Keywords

IVIG; Plasmapheresis; Blood Collection; Immune Globulin; Severe Acute Respiratory Syndrome; SARS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of SARS occurring greater than or equal to 3 months prior to screening. (objective documentation of SARS is not necessary)
• The ability to understand and willingness to sign a written consent form and comply with study requirements and procedures.
• SARS Ab level greater than or equal to 1:80
• Adequate clinical parameters (must meet all of the criteria below):
• Afebrile (temperature less than 38 degrees C)
• Systolic blood pressure greater than 100 and less than 160 mmHg
• Diastolic blood pressure greater than 50 and less than 100 mmHg
• Heart rate between 50-100 beats/minute
• Weight greater than or equal to 110 pounds (50kg)
• Adequate laboratory parameters (must meet all of the criteria below):
• Hemoglobin greater than or equal to 12.5 g/dL for females or 13 grams/dL for males
• HCT greater than or equal to 38%
• Platelets greater than or equal to 150,000 x 10(3)/microL
• Total serum protein greater than or equal to 6.0 grams/100 milliliters of blood
• ALT less than 1.5 Upper limit of normal

You may not qualify if:

• Age less than 18 years old, or greater than 56 years old.
• Signs of active respiratory infection including cough, dyspnea, or oxygen requirement.
• Subjective fever in the last 3 days
• History of headache with fever within the past 7 days.
• Known history of congestive heart failure, pulmonary hypertension or other diseases in which the fluid shifts associated with apheresis present more than minimal risk.
• Known history of bleeding diathesis or therapeutic anticoagulation.
• Bilateral mastectomy or other relative contraindications to peripheral venous catheter insertion.
• Within the last week has:
• Taken traditional Chinese medicines.
• Received hepatitis B vaccination.
• Within the last 3 weeks has:
• \- Received live-attenuated vaccines such as BCG, yellow fever, measles, mumps, poliomyelitis (oral), or live attenuated typhoid fever.
• Within the last 4 weeks has:
• \- Received rubella or varicella zoster (chicken pox) vaccination.
• Within the last 6 weeks has:

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

The Chinese University of Hong Kong

Hong Kong, China

Location

Related Publications (1)

• Fouchier RA, Kuiken T, Schutten M, van Amerongen G, van Doornum GJ, van den Hoogen BG, Peiris M, Lim W, Stohr K, Osterhaus AD. Aetiology: Koch's postulates fulfilled for SARS virus. Nature. 2003 May 15;423(6937):240. doi: 10.1038/423240a.

  PMID: 12748632 BACKGROUND

MeSH Terms

Conditions

Severe Acute Respiratory Syndrome

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Sponsor Type: NIH

Study Record Dates

• First Submitted: June 19, 2006
• First Posted: June 21, 2006
• Study Start: July 6, 2005
• Study Completion: February 8, 2007
• Last Updated: July 2, 2017

Record last verified: 2007-02-08

Locations

CN (1)