Collection of Anti-SARS-CoV-2 Immune Plasma
Condition: Coronavirus Disease 2019 (COVID-19)
MeSH terms: COVID-19; Coronavirus Infections
Study type: Observational

Summary: 
      Background:

      The human disease caused by SARS-CoV-2 is called COVID-19. In most cases, COVID-19 is a mild
      to moderate respiratory illness. But it can also be more severe and even lead to death. There
      is no vaccine to prevent SARS-CoV-2 infection. There is also no therapy to treat COVID-19.
      Researchers want to collect plasma from adults who have recovered from COVID-19, which may
      help them develop treatments.

      Objective:

      To collect anti-SARS-CoV-2 immune plasma from adult volunteers who have recovered from
      COVID-19.

      Eligibility:

      Males and females ages 18 to 70 who have a history of COVID-19 like illness or positive test
      for SARS-CoV-2, and have a minimum level of SARS-CoV-2 antibodies as specified by the study.

      Design:

      This study consists of 2 parts: 1) screening for SARS-CoV-2 antibody titer and eligibility to
      donate plasma and 2) plasma collection by apheresis. Study sites may participate in 1 part
      alone (either screening or plasma collection only) or both parts (screening and plasma
      collection).

      For screening part: Participants will be screened for their eligibility to join this research
      study with a medical history and physical exam. Their vital signs (blood pressure, heart
      rate, temperature, respiration rate) will be taken. Their weight and height will be recorded.
      They will give a blood sample for clinical laboratory tests of their general health and a
      research test for SARS-CoV-2 antibodies. They will discuss their history of COVID-19-like
      illness and any testing for SARS-CoV-2. They will be evaluated for their ability to donate
      plasma.

      For plasma collection part: Subjects meeting criteria for plasma donation and found to have
      high neutralizing antibody titers and who plan to donate plasma under this part of the study
      will be scheduled for 1 (and up to 20) plasma collection sessions. These will occur no less
      than 7 days apart.

      Prior to each donation, participants will have a brief physical exam and complete a donor
      history questionnaire. They will be asked about any current SARS-CoV-2 infection symptoms.

      At each donation, plasma will be taken through a standard apheresis procedure. For this,
      blood will be withdrawn through a needle placed in the participant's arm vein. A machine will
      separate the plasma from the red cells. The red cells will be returned to the participant,
      either through the same needle or through a second needle in the other arm.

      Participation may last up to 240 days.
    

Detailed description: 
      Coronavirus disease 2019 (COVID-19) is a respiratory disease caused by a novel coronavirus
      named severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and causes substantial
      morbidity and mortality. There is currently no vaccine to prevent infection with SARS-CoV-2
      or therapeutic agent to treat COVID-19. The objective of this protocol is the identification
      of eligible donors and collection of anti-SARSCoV-2 immune plasma from convalescent survivors
      of COVID-19 illness.

      Potential subjects will be screened for eligibility to participate in plasma donations and
      their blood measured for antibodies to SARS-CoV-2. Enrolled subjects will receive a baseline
      physical and laboratory examination. Subjects with high SARS-CoV-2 neutralizing antibody
      titers who meet standard blood bank criteria for plasma donation will then be scheduled for
      plasma collection sessions. Following testing of the collected plasma for potential
      pathogens, this plasma may be used and/or converted into an intravenous immunoglobulin (IVIG)
      preparation for further study.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Convalescent survivors of COVID-19 will be recruited at sites around the US.
      
Biospecimen description: 
      Serum, plasma
    
Keywords: Coronavirus; COVID-19; IVIG; Convalescent plasma; Severe acute respiratory syndrome coronavirus 2