18 and older, any sex, with COVID-19. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Plasma ViscosityPrimary· Day 1 (within 24 hours prior to TPE), Day 4 (within 24 hours of last TPE)
Plasma viscosity is measured in centipoise (cP). The normal range is 1.4 - 1.8 cP and measurements above this range indicate increased viscosity.
Baseline
Group
Value
95% CI
Therapeutic Plasma Exchange (TPE)
2.35
± 0.37
Standard of Care
2.47
± 0.34
Post-treatment
Group
Value
95% CI
Therapeutic Plasma Exchange (TPE)
1.61
± 0.09
Standard of Care
2.47
± 0.48
Cumulative Incidence of Adverse EventsPrimary· Up to Day 28
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.
Group
Value
95% CI
Therapeutic Plasma Exchange (TPE)
1
Cumulative All Cause MortalitySecondary· Up to Day 28
The number of participants dying from any cause is reported as a cumulative measures of mortality.
Day 1 to Day 3
Group
Value
95% CI
Therapeutic Plasma Exchange (TPE)
0
Standard of Care
0
Day 1 to Day 7
Group
Value
95% CI
Therapeutic Plasma Exchange (TPE)
0
Standard of Care
0
Day 1 to Day 14
Group
Value
95% CI
Therapeutic Plasma Exchange (TPE)
0
Standard of Care
2
Day 1 to Day 21
Group
Value
95% CI
Therapeutic Plasma Exchange (TPE)
1
Standard of Care
4
Day 1 to Day 28
Group
Value
95% CI
Therapeutic Plasma Exchange (TPE)
2
Standard of Care
5
Cumulative Count of Bleeding and Thromboembolic ComplicationsSecondary· Up to Day 28
The number of bleeding and thromboembolic complications will be compared between study arms. This endpoint is a composite outcome including any acute bleeding requiring transfusion support, venous thrombosis (deep vein thrombosis or pulmonary embolism), arterial clots (myocardial infarction, stroke, limb ischemia), renal replacement therapy or catheter line related clots. The values reported are cumulative.
Day 1 to Day 3
Group
Value
95% CI
Therapeutic Plasma Exchange (TPE)
0
Standard of Care
0
Day 1 to Day 7
Group
Value
95% CI
Therapeutic Plasma Exchange (TPE)
1
Standard of Care
0
Day 1 to Day 14
Group
Value
95% CI
Therapeutic Plasma Exchange (TPE)
1
Standard of Care
0
Day 1 to Day 21
Group
Value
95% CI
Therapeutic Plasma Exchange (TPE)
2
Standard of Care
2
Day 1 to Day 28
Group
Value
95% CI
Therapeutic Plasma Exchange (TPE)
2
Standard of Care
2
Time to Treatment FailureSecondary· Up to Day 28
Time to treatment failure will be assessed in days and is defined as plasma viscosity \> 3.5 cP and/or the participant is offered TPE outside of trial by primary clinical team.
Group
Value
95% CI
Therapeutic Plasma Exchange (TPE)
5.5
± 2.12
Standard of Care
2.5
± 3.54
Duration of ICU StaySecondary· Up to Day 48
The number of days spent in the ICU after study enrollment is presented here. All patients are included in calculating the reported mean, including those whose ICU stay ended due to death.
Group
Value
95% CI
Therapeutic Plasma Exchange (TPE)
23.1
± 15.7
Standard of Care
16.0
± 11.4
Duration of Hospital StaySecondary· Up to Day 48
The number of days spent hospitalized after study enrollment is presented here. All patients are included in calculating the reported mean, including those whose hospitalization ended due to death.
Group
Value
95% CI
Therapeutic Plasma Exchange (TPE)
27.2
± 12.4
Standard of Care
21.7
± 12.0
Discharge DispositionSecondary· Up to Day 48
The number of participants in each study arm discharged to home or to a long-term acute care (LTAC) hospital, versus palliative care or death.
Group
Value
95% CI
Therapeutic Plasma Exchange (TPE)
7
Standard of Care
5
Therapeutic Plasma Exchange (TPE)
3
Standard of Care
5
Clinical Status ScoreSecondary· Day 1 (day of study enrollment), Day 4 (one day after second TPE treatment), Days 7, 14, 21, and 28
The clinical status of participants was assessed using a single item modified from the World Health Organization (WHO) ordinal clinical severity scale for COVID. The instrument was customized for this study to evaluate thrombotic/bleeding events. In this 12-point ordinal scale, a score of 1 indicates no evidence of infection and the severity of the clinical status increases as the number of necessary interventions increases to the final score of 12, which is death. All patients were included at every timepoint recorded, with "terminal" scores carried over from the measure before for those that
Day 1 (day of study enrollment)
Group
Value
95% CI
Therapeutic Plasma Exchange (TPE)
7.0
6.0 – 7.75
Standard of Care
8.0
7.25 – 8.0
Day 4 (1 day after second TPE treatment)
Group
Value
95% CI
Therapeutic Plasma Exchange (TPE)
7.0
6.0 – 7.0
Standard of Care
8.0
7.25 – 8.0
Day 7
Group
Value
95% CI
Therapeutic Plasma Exchange (TPE)
7.0
6.0 – 8.0
Standard of Care
8.0
7.0 – 8.0
Day 14
Group
Value
95% CI
Therapeutic Plasma Exchange (TPE)
8.0
6.0 – 8.0
Standard of Care
7.5
7.0 – 9.75
Day 21
Group
Value
95% CI
Therapeutic Plasma Exchange (TPE)
7.5
5.5 – 8.0
Standard of Care
8.0
7.0 – 12.0
Day 28
Group
Value
95% CI
Therapeutic Plasma Exchange (TPE)
7.0
5.5 – 8.75
Standard of Care
10.0
7.0 – 12.0
Ventilator DaysSecondary· Up to Day 28
The number of days participants are on a ventilator, among participants who were ever on a ventilator after study enrollment.
Group
Value
95% CI
Therapeutic Plasma Exchange (TPE)
22.6
± 11.6
Standard of Care
19.2
± 11.2
Positive End-Expiratory Pressure (PEEP)Secondary· Day 1 (day of study enrollment), Day 4 (one day after second TPE treatment), Days 7, 14, 21, and 28
PEEP during ventilator use is measured in centimeters of water (cmH2O) and is the pressure in the lungs above atmospheric pressure, at the end of an exhalation. Higher PEEP (10 cmH2O or greater) may be associated with improved mortality, compared with PEEP below 10 cmH2O.
Day 1 (day of study enrollment)
Group
Value
95% CI
Therapeutic Plasma Exchange (TPE)
12.7
± 5.0
Standard of Care
15.9
± 5.9
Day 4 (one day after second TPE treatment)
Group
Value
95% CI
Therapeutic Plasma Exchange (TPE)
11.6
± 4.3
Standard of Care
13.0
± 3.7
Day 7
Group
Value
95% CI
Therapeutic Plasma Exchange (TPE)
13.0
± 6.2
Standard of Care
11.3
± 3.9
Day 14
Group
Value
95% CI
Therapeutic Plasma Exchange (TPE)
13.0
± 2.0
Standard of Care
13.3
± 2.7
Day 21
Group
Value
95% CI
Therapeutic Plasma Exchange (TPE)
11.0
± 1.2
Standard of Care
11.0
± 2.0
Day 28
Group
Value
95% CI
Therapeutic Plasma Exchange (TPE)
11.0
± 2.6
Standard of Care
12.7
± 7.0
Sequential Organ Failure Assessment (SOFA) ScoreSecondary· Day 1 (day of study enrollment), Day 4 (one day after second TPE treatment), Days 7, 14, 21, and 28
The Sequential Organ Failure Assessment (SOFA) score is a method of predicting mortality that is based on the degree of dysfunction of six organ systems (respiratory, nervous, cardiovascular, liver, coagulation, and kidneys). Each organ system is scored between 0 and 4, where 0 indicates normal function and 4 indicates a high degree of dysfunction. Total scores range from 0 to 24. A score of 0-6 is associated with a mortality rate of less than 10% while a score between 16 and 24 is associated with a greater than 90% mortality rate.
Day 1 (day of study enrollment)
Group
Value
95% CI
Therapeutic Plasma Exchange (TPE)
10.5
8.5 – 12.75
Standard of Care
13.0
11.25 – 14.0
Day 4 (one day after second TPE treatment)
Group
Value
95% CI
Therapeutic Plasma Exchange (TPE)
11.0
7.75 – 12.5
Standard of Care
11.5
11.0 – 12.75
Day 7
Group
Value
95% CI
Therapeutic Plasma Exchange (TPE)
11.0
10.0 – 12.0
Standard of Care
12.0
11.25 – 13.75
Day 14
Group
Value
95% CI
Therapeutic Plasma Exchange (TPE)
12.5
8.75 – 13.75
Standard of Care
12.5
11.0 – 15.0
Day 21
Group
Value
95% CI
Therapeutic Plasma Exchange (TPE)
11.5
8.75 – 12.0
Standard of Care
13.0
10.75 – 15.75
Day 28
Group
Value
95% CI
Therapeutic Plasma Exchange (TPE)
11.5
8.25 – 12.75
Standard of Care
12.0
9.0 – 15.75
Adverse events — posted to ClinicalTrials.gov
Time frame: Information on TPE-associated adverse events was collected in patients receiving the study intervention (TPE) beginning with the initiation of the first TPE and continued up to 28 days after study enrollment. Adverse events were not collected for participants in the standard of care study arm..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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).
Publications & conference data
7 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07183709 — Safety and Immunogenicity Trial of PepGNP-COVID19 Vaccine in Adults
· Phase 1
· active not recruiting
NCT07300839 — A Study to Learn About a COVID-19 Vaccine in Healthy Adults 50 Through 64 Years of Age
· Phase 3
· active not recruiting
NCT07221162 — A Safety and Immunogenicity Trial of Boost-2867 Vaccine, Via Intranasal and Intramuscular Routes
· Phase 1
· recruiting
NCT07215520 — Safety and Tolerability of a Newcastle Disease Virus-Based Mucosal COVID-19 Vaccine in Previously Vaccinated Adults
· Phase 2
· recruiting
NCT07222384 — A Study to Learn About BNT162b2 (LP.8.1)-Adapted Vaccine Against SARS-CoV-2 in Children 5 Through 11 Years of Age That A
· Phase 3
· active not recruiting
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Emory University
Last refreshed: 21 December 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04441996.