CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 12 enrolled
Drug / intervention
Control group +1 moredevice
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/NCT04353674
NCT04353674N/ACompleted

Novel Extracorporeal Treatment to Modulate Hyperinflammation in COVID-19 Patients

In Brief

A clinical study evaluating Control group and SLEDD with a L-MOD for COVID-19 and SARS. Completed, enrolled 12 participants across 2 sites.

Detailed Summary

Current treatment recommendations are based on very limited evidence and reliant on the deployment of pharmacological strategies of doubtful efficacy, high toxicity, and near universal shortages of supply. On a global scale, there is a desperate need for readily available therapeutic options to safely and cost effectively target the hyper-inflammatory state in ICU patients based on management of severe COVID-19 (evidence of acute respiratory distress syndrome). The study team proposes to use slow low-efficiency daily dialysis to provide an extracorporeal circuit to target this cytokine storm using immunomodulation of neutrophils with a novel leucocyte modulatory device (L-MOD) to generate an anti-inflammatory phenotype, but without depletion of circulating factors.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCOVID-19, SARS
CountriesCanada
Collaborators--

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedApr 20, 2020
Enrollment StartApr 28, 2020
Primary CompletionDec 30, 2023
Study CompletionMar 15, 2024
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 6.2 years ago

Interventions

Control groupdevice

Patients randomized into this group will receive standard of care for COVID-19 infection

SLEDD with a L-MODdevice

Patients randomized to this group will undergo slow low efficiency daily dialysis for approximately 12 hours, 2 days in a row with a leukocyte modulatory device.