Magnesium Citrate plus probiotic for COVID-19 (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

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 7 days for reporting.

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.

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