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Mineral Supplement
"CHANGE COVID-19 Severity" (CHANGE Trial)
Phase 1 & 2
Waitlist Available
Research Sponsored by Vanderbilt University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 7 days
Summary
This trial is testing if a magnesium supplement and beneficial bacteria pills can help adults in the hospital with COVID-19 recover better by supporting their body functions and immune system.
Eligible Conditions
- COVID-19
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and 7 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 7 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
COVID Ordinal Outcome Scale
Secondary study objectives
Change in Oxygen Requirements From Baseline to Day 7 by Treatment Group
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Magnesium Citrate plus a Probiotic Arm:Experimental Treatment1 Intervention
Participants assigned to the magnesium citrate plus a probiotic arm will receive 1 bottle of magnesium citrate 296 mL PO once to be taken within a 4-hour period, (about 10 oz.). Because magnesium citrate remains within the intestinal lumen, a second bottle can be provided if there is limited bowel movement. Patients will be asked to take 2 capsules of probiotics twice daily for six days or until discharge, whichever is earlier.
Group II: PlaceboPlacebo Group1 Intervention
Participants randomized to the placebo arm will receive matching placebo 296 mL PO once to be taken within a 4-hour period, (about 10 oz.) and 2 cellulose capsules twice daily for six days or until discharge, whichever is earlier. The placebo will be flavored to match the taste of the interventional arm.
Who is running the clinical trial?
Vanderbilt University Medical CenterLead Sponsor
904 Previous Clinical Trials
934,056 Total Patients Enrolled
20 Trials studying COVID-19
38,329 Patients Enrolled for COVID-19