ANTIBODY-LEVEL BASED ANALYSIS OF COVID-19 CONVALESCENT SERUM (ABACCuS)
Condition: COVID-19; Severe Acute Respiratory Syndrome (SARS); Coronavirus Infections
MeSH terms: COVID-19; Coronavirus Infections; Severe Acute Respiratory Syndrome
Intervention: COVID-19 convalescent plasma
Intervention description: Participants will receive 1 unit of convalescent plasma procured from donors who have: 1) been symptom free for 14 days and screen negative via nasopharyngeal swab or 2) symptom free for at least 28 days or 3) individuals who have never had symptoms of COVID-19 but were found to have elevated anti-SARS-CoV-2 IgG by a serology test deemed to be of acceptable quality and fitting the current guidance by the FDA. Participants, clinicians, investigators and outcomes assessors will be blinded to the amount of anti-SARS-CoV-2 IgA and IgG present in each unit
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective, single health system, non-randomized, open-label study.
Masking: None (Open Label)
Masking description: No parties blinded as to receipt of study article. Participant, care provider and investigator blinded to actual antibody concentration in unit of plasma provided.
Enrollment: 71.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: therapeutic treatment; COVID-19 convalescent plasma; anti-SARS-CoV-2 antibody; IgA; IgG; COVID-19 pandemic

Summary:

      The goal of this study is to evaluate the safety and effectiveness of Coronavirus-90
      (COVID-19) convalescent plasma for the treatment of COVID-19. Plasma is the liquid part of
      blood that is left when all the blood cells have been removed. Convalescent means it is taken
      from people who were infected with COVID-19 and recovered. The use of this blood product to
      treat COVID-19 is investigational, which means the U.S. Food and Drug Administration has not
      yet approved it to be sold commercially. This is a human blood product collected by licensed
      blood banks. Donors of COVID-19 convalescent plasma must meet all standard blood donor
      criteria and must also meet all criteria set by the FDA for being a donor of COVID-19
      convalescent plasma.

      A total of 500 patients will take part in the study at 8 hospitals within Beaumont. Similar
      studies are being done at other centers, but they are not directly related to this study.

      Participants will be assigned to a study group depending on how sick they are.

        -  Group A: Those who require more than 6 liters (L) of supplemental oxygen but are not on
           a ventilator

        -  Group B: Those who require a ventilator to preserve their life.

      Both groups will receive one unit (approximately 200ml or just under 1 cup) of COVID
      convalescent plasma. The transfusion will be given over about 30 minutes via an IV. Blood
      samples will be taken prior to and one hour after the transfusion to measure participant
      antibodies against Severe Acute Respiratory Syndrome-Coronavirus 2 (SARS-CoV-2) and a
      nasopharyngeal swab (deep in the nostril) will be taken to test for presence of the
      SARS-CoV-2 virus. One hour after the transfusion a blood sample will be taken to measure
      antibody levels to determine if the plasma caused the antibody level to rise. Similarly,
      blood samples will be taken to measure antibodies against SARS-CoV-2 and a nasopharyngeal
      swab will be taken to test for presence of the SARS-CoV-2 virus 1, 3 and every 7 days after
      the transfusion while the participant is in the hospital The participant's final health
      status will be determined on day 28. Hospital records will be monitored for 90 days after
      discharge to determine if the participant is readmitted to the hospital.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects must be 18 years of age or older.

          -  Hospitalized with confirmed COVID-19 infection via COVID-19 SARS-CoV-2
             Reverse-transcription polymerase chain reaction (RT-PCR) testing.

          -  Symptoms consistent with COVID-19 infection (fever, acute onset cough, shortness of
             breath) at time of screening.

          -  Patient requires >6 L nasal cannula oxygen (Group A) or intubated (Group B).

          -  Patient (or their legal authorized representative) is willing and able to provide
             written informed consent and comply with all protocol requirements.

        Exclusion Criteria:

          -  For patients in Group A admitted for >14 days

          -  Female subjects with positive pregnancy test, breastfeeding, or planning to become
             --pregnant or breastfeed during the study period.

          -  Receipt of pooled immunoglobulin in past 30 days.

          -  Contraindication to transfusion or history of prior reactions to transfusion blood
             products.

          -  Patients currently undergoing cancer treatment or those who are presently
             immunocompromised.

          -  Patient who in the opinion of the investigator will not be a good study candidate.