Therapeutic Plasma Exchange for COVID-19-associated Hyperviscosity

NCT04441996 | Completed Phase 4 Results FDA Drug

• 1 other identifier: STUDY00000949
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 3

Brief 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).

Conditions

COVID-19

Keywords

Hyperviscosity

Outcome Measures

Primary Outcomes (2)

• Plasma Viscosity

  Plasma viscosity is measured in centipoise (cP). The normal range is 1.4 - 1.8 cP and measurements above this range indicate increased viscosity.

  Day 1 (within 24 hours prior to TPE), Day 4 (within 24 hours of last TPE)

• Cumulative Incidence of Adverse Events

  The primary safety endpoint is assessed as the cumulative incidence of adverse events directly associated with TPE during the study period as determined by clinical judgment of ICU team providing direct patient care and the study PI.

  Up to Day 28

Secondary Outcomes (38)

• Cumulative All Cause Mortality

  Up to Day 28

• Cumulative Count of Bleeding and Thromboembolic Complications

  Up to Day 28

• Time to Treatment Failure

  Up to Day 28

• Duration of ICU Stay

  Up to Day 48

• Duration of Hospital Stay

  Up to Day 48

Study Arms (2)

Therapeutic plasma exchange (TPE)

EXPERIMENTAL

Participants with COVID-19-associated hyperviscosity randomized to receive therapeutic plasma exchange (TPE).

Biological: Therapeutic plasma exchange (TPE)

Standard of care

ACTIVE COMPARATOR

Participants with COVID-19-associated hyperviscosity randomized to receive standard of care treatment.

Other: Standard of care

Interventions

Therapeutic plasma exchange (TPE) BIOLOGICAL

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.

Therapeutic plasma exchange (TPE)

Standard of care OTHER

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.

Standard of care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Emory University: lead

Study Sites (3)

Emory Saint Joseph's Hospital

Atlanta, Georgia, 30308, United States

Location

Emory University Hospital Midtown

Atlanta, Georgia, 30308, United States

Location

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

COVID-19; Thrombophilia

Interventions

Plasma Exchange; Standard of Care

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Blood Transfusion; Biological Therapy; Therapeutics; Plasmapheresis; Blood Component Removal; Sorption Detoxification; Extracorporeal Circulation; Surgical Procedures, Operative; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Cheryl Maier MD, PhD
• Organization: Emory University

cheryl.maier@emory.edu

404-712-2795

Study Officials

• Cheryl Maier, MD, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 19, 2020
• First Posted: June 22, 2020
• Study Start: July 17, 2020
• Primary Completion: March 18, 2021
• Study Completion: March 18, 2021
• Last Updated: December 21, 2022
• Results First Posted: December 21, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)