CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 23 enrolled
Drug / intervention
OCTAPLASdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04623255
NCT04623255Phase 2Completed

A Randomised Controlled Trial of Plasma Exchange With Standard of Care Compared to Standard of Care Alone in the Treatment of Severe COVID-19 Infection (COVIPLEX)

University College, London·interventional·Posted Nov 10, 2020·Updated Jun 7, 2024

In Brief

A Phase 2 clinical trial evaluating OCTAPLAS for COVID19. Completed, enrolled 23 participants across 1 site.

Detailed Summary

The rationale in severe COVID19 infection is to undertake PEX to aid reduction of the hyperinflammation and reduce the morbidity and mortality to the lungs, but also systemically, such as the heart, kidneys and brain. A feasibility study of PEX therapy has been undertaken and confirmed a reduction in the inflammatory markers, no VTE/arterial events and normalisation of the renal function and cardiac function throughout the period of therapy. As plasma exchange is an intensive treatment modality, blocks of 5 daily PEX will be undertaken. Further blocks of PEX treatment can be initiated as dictated by the clinical and laboratory parameters. Unlike many therapeutic schedules, there is no immunosuppression associated with PEX; indeed, the resulting decrease in inflammatory markers were shown to be associated with an increase and sustained lymphocytes count.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCOVID19
CountriesUnited Kingdom
Collaborators--

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedNov 10, 2020
Enrollment StartOct 16, 2020
Primary CompletionJan 31, 2022
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 5.6 years ago

Interventions

OCTAPLASdrug

plasma exchange