Clinical Trial Sponsors: National Institutes of Health Clinical Center (CC)

  Source:		NCT00342524

    		Collection of Convalescent SARS Plasma by


			First Update June 19, 2006
			Last Update June 30, 2017

			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

			12748632 Aetiology: Koch's postulates fulfilled
			for SARS virus.

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