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Mineral Supplement
Magnesium Citrate plus probiotic for Coronavirus Disease (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
Sore throat
Age ≥18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 7 days
Awards & highlights
CHANGE Trial Summary
This trial is testing whether magnesium citrate combined with a probiotic can help treat adults hospitalized with COVID-19.
Eligible Conditions
- Coronavirus Disease
CHANGE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowCHANGE Trial 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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
COVID Ordinal Outcome Scale
Secondary outcome measures
Change in Oxygen Requirements From Baseline to Day 7 by Treatment Group
CHANGE 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.
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Who is running the clinical trial?
Vanderbilt University Medical CenterLead Sponsor
856 Previous Clinical Trials
672,169 Total Patients Enrolled
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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