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Immunomodulatory Device
SLEDD for COVID-19
N/A
Recruiting
Led By Christopher W McIntyre, MD
Research Sponsored by Lawson Health Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from date of randomization until the date of icu discharge up to 2 months
Awards & highlights
Study Summary
This trial will test whether slow low-efficiency daily dialysis can help improve the outcomes of people with severe COVID-19 by reducing the cytokine storm.
Who is the study for?
Adults over 18 with a high likelihood of COVID-19, as determined by specialists, needing vasopressor support and suffering from acute respiratory distress syndrome that requires ICU care. Not for those with citrate anticoagulation issues, unconfirmed COVID-19, pregnancy or chronic immune depression.Check my eligibility
What is being tested?
The trial is testing the use of slow low-efficiency daily dialysis (SLEDD) combined with a novel leucocyte modulatory device (L-MOD) to reduce severe inflammation in ICU patients with COVID-19 by modifying white blood cells to fight inflammation without removing important circulating factors.See study design
What are the potential side effects?
Potential side effects may include reactions related to dialysis treatment such as changes in blood pressure, muscle cramps or infections. The L-MOD's specific side effects are not detailed but could involve immune system alterations.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
You are 18 years old or older.
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The doctors think you might have a serious case of COVID-19.
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You need medication to support your blood pressure.
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You have been admitted to the intensive care unit for acute respiratory distress syndrome.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from date of randomization until the date of icu discharge up to 2 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from date of randomization until the date of icu discharge up to 2 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Efficacy of a L-MOD against controls receiving supportive care in ICU.
Secondary outcome measures
Hospital Discharge
Intubation length
Leukocyte Monitoring
+6 moreTrial Design
2Treatment groups
Active Control
Placebo Group
Group I: SLEDD with a L-MODActive Control1 Intervention
Patients diagnosed with severe COVID-19: Those admitted to the intensive care unit with evidence of severe respiratory distress syndrome will undergo slow low efficiency daily dialysis for approximately 12 hours, 2 days in a row with a leukocyte modulatory device.
Group II: ControlPlacebo Group1 Intervention
Patients diagnosed with severe COVID-19: Those admitted to the intensive care unit with evidence of severe respiratory distress syndrome will undergo standard of care
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Who is running the clinical trial?
Lawson Health Research InstituteLead Sponsor
654 Previous Clinical Trials
413,145 Total Patients Enrolled
11 Trials studying COVID-19
1,764 Patients Enrolled for COVID-19
Christopher W McIntyre, MDPrincipal InvestigatorWestern University
4 Previous Clinical Trials
160 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have medical reasons that make it unsafe for you to use regional citrate anticoagulation.You are 18 years old or older.The doctors think you might have a serious case of COVID-19.You have not been confirmed to have COVID-19.You need medication to support your blood pressure.You have been admitted to the intensive care unit for acute respiratory distress syndrome.Long-term weakened immune system
Research Study Groups:
This trial has the following groups:- Group 1: Control
- Group 2: SLEDD with a L-MOD
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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