COVID-19 Clinical Trial
Official title:
Novel Extracorporeal Treatment to Modulate Hyperinflammation in COVID-19 Patients
NCT number | NCT04353674 |
Other study ID # | 115785 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | April 28, 2020 |
Est. completion date | March 15, 2024 |
Verified date | March 2024 |
Source | Lawson Health Research Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 12 |
Est. completion date | March 15, 2024 |
Est. primary completion date | December 30, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Age greater than or equal to 18 years - High clinical suspicion of COVID-19 from the opinion of both infectious disease specialist (s) and the ICU team - Evidence of acute respiratory distress syndrome requiring admission to the Critical Care Trauma Centre Medical Surgical ICU, or the Cardiac Surgical Recovery Unit - Vasopressor support Exclusion Criteria: - Pregnant - Unconfirmed COVID-19 - Chronic immune depression - Contra-indications to regional citrate anticoagulation |
Country | Name | City | State |
---|---|---|---|
Canada | University Hospital | London | Ontario |
Canada | Victoria Hospital - Critical Care Trauma Centre | London | Ontario |
Lead Sponsor | Collaborator |
---|---|
Lawson Health Research Institute |
Canada,
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Wu C, Chen X, Cai Y, Xia J, Zhou X, Xu S, Huang H, Zhang L, Zhou X, Du C, Zhang Y, Song J, Wang S, Chao Y, Yang Z, Xu J, Zhou X, Chen D, Xiong W, Xu L, Zhou F, Jiang J, Bai C, Zheng J, Song Y. Risk Factors Associated With Acute Respiratory Distress Syndro — View Citation
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* Note: There are 17 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Efficacy of a L-MOD against controls receiving supportive care in ICU. | Efficacy will be evaluated by reduction of vasopressor support (converted to norepinephrine dose equivalents) compared to control group. | Through dialysis, on average of 12 hours, two days in a row | |
Secondary | Mortality | Time to ICU and hospital discharge compared to case-matched controls | From date of randomization until the date of death from any cause, whichever came first, assessed up to 2 months | |
Secondary | Hospital Discharge | Time to ICU and hospital discharge compared to case-matched controls | From date of randomization until the date of hospital discharge or death from any cause, whichever came first, assessed up to 2 months | |
Secondary | Leukocyte Monitoring | Over the course of the disease white blood cells will be monitored (i.e. neutrophils, macrophages...) | Through dialysis, on average of 12 hours, two days in a row and again on day 5 in the ICU | |
Secondary | Sequential Organ Failure Assessment (SOFA) Score | Evolution of the Sequential Organ Failure Assessment (SOFA) score. The SOFA score ranges from 0 to 24. The higher score means the worst outcome. | From date of randomization until the date of ICU discharge or death from any cause, whichever came first, assessed up to 1 months | |
Secondary | Intubation length | intubation length will be recorded (in day) | From date of randomization until the date of ICU discharge up to 2 months | |
Secondary | Markers of Inflammation | Evolution of hsCRP during dialysis treatment | Through dialysis, on average of 12 hours, two days in a row and again after day 4 and no later than day 7 in the ICU | |
Secondary | Leukocytes and Macrophages | Characterization of activated/desactivated leukocyte and macrophage subsets in the blood | Through dialysis, on average of 12 hours, two days in a row and again after day 4 and no later than day 7 in the ICU | |
Secondary | Myocardial damage | Myocardial damage will be assessed by troponin measurement (ng/mL) | From date of randomization until the date of ICU discharge up to 2 months | |
Secondary | Renal recovery | Renal recovery will be assessed by serum creatinin measurement (micromol/L) | From date of randomization until the date of ICU discharge up to 2 months |
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