Covid 19 Clinical Trials

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.

NCT04353674 COVID-19 SARS Device: Control group Device: SLEDD with a L-MOD

Primary Outcomes

Description: Efficacy will be evaluated by reduction of vasopressor support (converted to norepinephrine dose equivalents) compared to control group.

Measure: Efficacy of a L-MOD against controls receiving supportive care in ICU.

Time: Through dialysis, on average of 12 hours, two days in a row

Secondary Outcomes

Description: Time to ICU and hospital discharge compared to case-matched controls

Measure: Mortality

Time: From date of randomization until the date of death from any cause, whichever came first, assessed up to 2 months

Description: Time to ICU and hospital discharge compared to case-matched controls

Measure: Hospital Discharge

Time: From date of randomization until the date of hospital discharge or death from any cause, whichever came first, assessed up to 2 months

Description: Over the course of the disease white blood cells will be monitored (i.e. neutrophils, macrophages...)

Measure: Leukocyte Monitoring

Time: Through dialysis, on average of 12 hours, two days in a row and again on day 5 in the ICU

Description: Evolution of the Sequential Organ Failure Assessment (SOFA) score. The SOFA score ranges from 0 to 24. The higher score means the worst outcome.

Measure: Sequential Organ Failure Assessment (SOFA) Score

Time: From date of randomization until the date of ICU discharge or death from any cause, whichever came first, assessed up to 1 months

Description: intubation length will be recorded (in day)

Measure: Intubation length

Time: From date of randomization until the date of ICU discharge up to 2 months

Description: Evolution of hsCRP during dialysis treatment

Measure: Markers of Inflammation

Time: Through dialysis, on average of 12 hours, two days in a row and again on day 5 in the ICU

Description: Characterization of activated/desactivated leukocyte and macrophage subsets in the blood

Measure: Leukocytes and Macrophages

Time: Through dialysis, on average of 12 hours, two days in a row and again on day 5 in the ICU

Description: Myocardial damage will be assessed by troponin measurement (ng/mL)

Measure: Myocardial damage

Time: From date of randomization until the date of ICU discharge up to 2 months

Description: Renal recovery will be assessed by serum creatinin measurement (micromol/L)

Measure: Renal recovery

Time: From date of randomization until the date of ICU discharge up to 2 months

CovidResearchTrials by Shray Alag

Covid 19 Research using Clinical Trials (Home Page)

SLEDD with a L-MODWiki

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Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation

Correlated Drug Terms (3)

Correlated MeSH Terms (2)

Correlated HPO Terms (0)

Clinical Trials

1 Novel Extracorporeal Treatment to Modulate Hyperinflammation in COVID-19 Patients

NCT04353674 COVID-19 SARS Device: Control group Device: SLEDD with a L-MOD

Primary Outcomes

Secondary Outcomes

No related HPO nodes (Using clinical trials)