Therapeutic Plasma Exchange for COVID-19-associated Hyperviscosity
Condition: COVID-19
MeSH terms: COVID-19
Intervention: Therapeutic plasma exchange (TPE); Standard of care
Intervention description: Participants will receive two treatments of TPE with frozen plasma (FP) replacement on two sequential days (Day 2 and Day 3). All procedures will be performed by the apheresis staff at the hospital sites, following institutional standard operating procedures. FP will be obtained from American Red Cross or LifeSouth Community Blood centers.; Participants will continue to receive standard of care and be closely monitored by ICU team for any change in clinical status, and any adverse events directly related to study intervention will be reported to the study investigator.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hyperviscosity

Summary:

      Many patients with Coronavirus Disease 2019 (COVID-19) have atypical blood clots. These blood
      clots can occur in either veins or arteries and be large, like in stroke or heart attack, or
      very tiny, called microthrombi. Some patients with COVID-19 even have blood clots despite
      being on anti-clotting medications. Blood with increased viscosity does not flow through the
      body normally, in the same way that syrup, a highly viscous liquid, and water, a minimally
      viscous liquid, flow differently. The researchers believe that hyperviscosity may contribute
      to blood clots and organ damage seen in patients with severe COVID-19. Plasma exchange
      removes a patient's plasma, which contains the large sticky factors that the researchers
      believe are increasing viscosity, and replaces it with plasma from healthy donors. In
      addition to providing important information about plasma exchange as a treatment in COVID-19
      for patients, this study will provide data to justify resource and staffing decisions.

      This study will enroll 20 participants who are critically ill from COVID-19. Participants
      will be randomized to receive therapeutic plasma exchange (TPE) or standard of care (SOC).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age ≥ 18 years

          -  Patients admitted to the ICU at Emory University Hospital, Emory University Hospital
             Midtown, or Emory Saint Joseph's Hospital

          -  Evidence of COVID-19 infection documented by a laboratory test either by one of the
             following:

               -  A diagnostic test (e.g., nasopharyngeal swab, tracheal aspirate, other)

               -  Positive serological test for severe acute respiratory syndrome coronavirus 2
                  (SARS-CoV-2) antibodies

               -  Medical records from outside institution

          -  Plasma viscosity >2.3 and <3.5 centipoise (cp) or Fibrinogen >800 mg/dL

        Exclusion Criteria:

          -  Patients with plasma viscosity > 3.5 cp

          -  Moribund patients that the ICU clinical team expects to die within 24 hours

          -  Patients with any condition that, in the opinion of the clinical team or investigator,
             could increase the subject's risk by participating in the study or confound the
             outcome of the study

          -  Patients participating in another clinical trial that prohibits the use of TPE

          -  Pregnant women

          -  Prisoners