Phase 4
N=20
Therapeutic Plasma Exchange for COVID-19-associated Hyperviscosity
COVID-19
Bottom Line
View on ClinicalTrials.gov: NCT04441996 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Dec 2022
Primary outcome: Primary: Plasma Viscosity — 2.35; 2.47; 1.61; 2.47 cP
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Therapeutic plasma exchange (TPE) (Biological); Standard of care (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Emory University
- Primary completion
- Mar 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Plasma Viscosity |
2.35; 2.47; 1.61; 2.47 | — |
| PRIMARY Cumulative Incidence of Adverse Events |
1 | — |
| SECONDARY Cumulative All Cause Mortality |
0; 0; 0; 0; 0; 2 | — |
| SECONDARY Cumulative Count of Bleeding and Thromboembolic Complications |
0; 0; 1; 0; 1; 0 | — |
| SECONDARY Time to Treatment Failure |
5.5; 2.5 | — |
| SECONDARY Duration of ICU Stay |
23.1; 16.0 | — |
| SECONDARY Duration of Hospital Stay |
27.2; 21.7 | — |
| SECONDARY Discharge Disposition |
7; 5; 3; 5 | — |
| SECONDARY Clinical Status Score |
7.0; 8.0; 7.0; 8.0; 7.0; 8.0 | — |
| SECONDARY Body Temperature |
— | — |
| SECONDARY Systolic Blood Pressure |
— | — |
| SECONDARY Diastolic Blood Pressure |
— | — |
| SECONDARY Heart Rate |
— | — |
| SECONDARY Respiratory Rate |
— | — |
| SECONDARY Ventilator Days |
22.6; 19.2 | — |
| SECONDARY Ventilator Oxygen Percent (FiO2) |
— | — |
| SECONDARY Positive End-Expiratory Pressure (PEEP) |
12.7; 15.9; 11.6; 13.0; 13.0; 11.3 | — |
| SECONDARY Vasopressor Requirements |
— | — |
| SECONDARY Need for Treatment From a Registered Respiratory Therapist (RRT) |
— | — |
| SECONDARY Sequential Organ Failure Assessment (SOFA) Score |
10.5; 13.0; 11.0; 11.5; 11.0; 12.0 | — |
| SECONDARY Partial Pressure of Arterial Oxygen (PaO2)/Percentage of Inspired Oxygen (FiO2) Ratio |
219; 166; 132; 157; 151; 141 | — |
| SECONDARY Ventilatory Ratio |
— | — |
| SECONDARY White Blood Count (WBC) |
— | — |
| SECONDARY Hemoglobin (Hb) |
— | — |
| SECONDARY Hematocrit (Hct) |
— | — |
| SECONDARY Platelet Count |
— | — |
| SECONDARY Mean Platelet Volume (MVP) |
— | — |
| SECONDARY Blood Urea Nitrogen (BUN) |
— | — |
| SECONDARY Creatinine |
2.5; 2.9; 2.0; 2.6; 2.3; 2.6 | — |
| SECONDARY Bilirubin |
— | — |
| SECONDARY Total Protein |
— | — |
| SECONDARY Albumin |
— | — |
| SECONDARY C-reactive Protein (CRP) |
226; 234; 83; 179; 153; 210 | — |
| SECONDARY Interleukin 6 (IL-6) |
— | — |
| SECONDARY Prothrombin Time (PT) |
— | — |
| SECONDARY International Normalized Ratio (INR) |
— | — |
| SECONDARY Activated Partial Thromboplastin Time (aPTT) |
— | — |
| SECONDARY Anti-factor Xa (Anti-Xa) |
— | — |
| SECONDARY Fibrinogen |
934; 860; 359; 807; 663; 806 | — |
| SECONDARY D-dimer |
5187; 1632; 3519; 6253; 4041; 1749 | — |
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 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
Data sourced from ClinicalTrials.gov (NCT04441996). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.