Collection of Convalescent SARS Plasma by Apheresis

Exclusion Criteria

• •1. Age less than 18 years old, or greater than 56 years old.
• •2. Signs of active respiratory infection including cough, dyspnea, or oxygen requirement.
• •3. Subjective fever in the last 3 days
• •4. History of headache with fever within the past 7 days.
• •5. Known history of congestive heart failure, pulmonary hypertension or other diseases in which the fluid shifts associated with apheresis present more than minimal risk.
• •6. Known history of bleeding diathesis or therapeutic anticoagulation.
• •7. Bilateral mastectomy or other relative contraindications to peripheral venous catheter insertion.
• •8. Within the last week has:
• •* Taken traditional Chinese medicines.
• •* Received hepatitis B vaccination.
• •9. Within the last 3 weeks has:
• •\- Received live-attenuated vaccines such as BCG, yellow fever, measles, mumps, poliomyelitis (oral), or live attenuated typhoid fever.
• •10. Within the last 4 weeks has:
• •\- Received rubella or varicella zoster (chicken pox) vaccination.
• •11. Within the last 6 weeks has:
• •* Received standard IVIG for hepatitis A or other indications.
• •* Received anti-tetanus toxoid or other passive immunizations with animal serum.
• •* Been diagnosed with West Nile virus infection.
• •12. Within the last 8 weeks:
• •\- Was vaccinated with the small pox vaccine, or was in close contact with someone who was vaccinated (i.e., close family member).
• •13. Within the last 3 months has:
• •* A history of unexplained weight loss of more than 10 lbs/4.5 kg.
• •* Has been seen by a physician or public health staff for investigation of TB.
• •* Current or previous participation in any other apheresis procedures/protocols (not related to this protocol).
• •14. Within the last 6 months has had:
• •* A diagnosis of Dengue fever.
• •* An induced abortion.
• •* A blood donation of a double unit of red cells.
• •15. Within the last 12 months has:
• •* Received any blood or blood component.
• •* Donated blood at a paid donation center (donations at a hospital blood bank do not apply).
• •* History of unsafe (multiple-use equipment) tattoo, acupuncture, or piercing practices.
• •* Received an organ transplant.
• •* Received a bone or skin graft.
• •* Lived with someone who has any type of hepatitis.
• •* Traveled to areas with malaria.
• •* Incarcerated for more than 72 hours.
• •* Oral or inhalation use of illegal drugs (i.e. those not prescribed by a physician).
• •* Received hepatitis B IVIG for passive immunity.
• •16. Within the last 12 months has had sexual contact with (any of the following):
• •* An individual having viral hepatitis.
• •* A prostitute or anyone else who takes money or drugs or other payment for sex.
• •* Anyone who has ever used needles to take drugs, steroids, or anything else not prescribed by their doctor.
• •* Anyone who has hemophilia or has used clotting factor concentrates.
• •* For females, a male who has ever had sexual contact with another male.
• •17. Within the last 2 years has:
• •\- Has received treatment for tuberculosis.
• •18. Within the last 3 years:
• •\- Has been diagnosed with malaria.
• •19. History of cancer that meets any one of the following criteria:
• •* Non-melanoma skin cancers within the last 1 year
• •* Melanoma or any other cancer (excluding non-melanoma skin cancers).
• •20. Medication history that includes any of the following:
• •* Finasteride (Proscar, Propecia) within the last 1 month.
• •* Isotretinoin (Accutane) within the last 1 month.
• •* Acitretin (Soriatane) within the last 3 years.
• •* Etretinate (Tegison) at any time.
• •* Dutasteride (Avodart) within the last 6 months.
• •* Viagra within the last week.
• •* Growth hormone made from human pituitary glands at any time
• •* Any growth hormone administered prior to 1985.
• •* Beef insulin from the United Kingdom at any time.
• •* Xenical or other weight reduction medications within the last week.
• •21. Has ever had (any of the following)
• •* Known history of HIV.
• •* Sexual contact with someone known to have HIV or HTLV.
• •* Known history of Hepatitis after the 11th birthday.
• •* Had a relative with Creutzfield-Jakob Disease, or been told that this disease is inherited within the family.
• •* Received blood transfusion in the United Kingdom.
• •* History of receiving money, drugs or other payment for sex.
• •* History of receiving clotting factor concentrates.
• •* History of a dura mater graft.
• •* History of babesiosis.
• •* For male donors, history of sexual contact with another male.
• •* Used needles to take drugs, steroids, or other medications not prescribed by a physician.
• •* Trypanosomiasis (Chagas' disease and sleeping sickness)
• •* Leshmaniasis (Kala-azar)
• •* Filariasis
• •* Q fever
• •* Yaws
• •* All venereal diseases (including genital herpes)
• •* Sexual contact with anyone who lived in listed African countries after 1977.
• •22. History of living 3 or more months in the UK from 1980-1996.
• •23. History of living 5 or more years in Europe since 1980.
• •24. Currently pregnant (if known).
• •1\. Positive urine pregnancy test.
• •1. Blood hemoglobin greater than or equal to 17 for males or females.
• •2. Pilots, fireman, scaffolding workers, divers, bus and truck drivers, crane operators or underground workers who are on duty or planned to work the day of donation.
• •3. Planned participation in dangerous sports such as rock climbing, hang gliding, or scuba-diving the day of donation.
• •4. Signs/symptoms of an acute respiratory disease.
• •5. Signs/symptoms of any skin disease at the site of phlebotomy or any such disease generalized to such an extent as to create a risk of contamination of the plasma.
• •6. Skin punctures or scars indicative of addiction to self-injected narcotics.
• •7. Persons with signs of debilitation, under nutrition, plethora, anaemia, jaundice, cyanosis, dyspnea, or mental instability.\\
• •8. In the opinion of the interviewer, a donor that: (either of the following)
• •* appears to be under the influence of any drug or alcohol
• •* for any reason does not appear to be providing reliable answers to medical history questions
• •9. Within the last 8 weeks, has not had the red blood cells returned during a plasmapheresis procedure.
• •10. Within the last 8 weeks has been a donor of a unit of whole blood.
• •11. Subjective fever or other symptoms suggestive of active infection.
• •12. Known exposure (since screening or previous donation) to HIV, Hepatitis B or Hepatitis C.
• •13. Received toxoid, killed vaccines, or recombinant vaccines such as cholera, typhoid, diphtheria, tetanus, hepatitis A, influenza, poliomyelitis (injection), or pertussis within the last 24 hours.
• •14. Received live-attenuated vaccines such as BCG, yellow fever, measles, mumps, poliomyelitis (oral), or live attenuated typhoid fever within the last 3 weeks.
• •15. Received rubella or varicella zoster (chicken pox) vaccination within the last 4 weeks.
• •16. Current or previous participation (within the last 3 months) in any other apheresis procedures/protocols (i.e. not related to this protocol).
• •17. Known or suspected pregnancy.