"CHANGE COVID-19 Severity"

• Status: Recruiting
• Trial end date: 2024-06-30
• Target enrollment: 0
• Participant gender: All

Summary

We are conducting an investigator-initiated, single center, blinded, placebo-controlled, randomized clinical trial evaluating magnesium citrate combined with a probiotic for the treatment of adults hospitalized with COVID-19.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vanderbilt University Medical Center
• Treatments: Magnesium citrate

Criteria

Inclusion Criteria:

1. Age ≥18 years

2. Currently hospitalized or in an emergency department with anticipated hospitalization.

3. Symptoms of acute respiratory infection, defined as one or more of the following:

1. Cough

2. Fever (> 37.5° C / 99.5° F)

3. Shortness of breath (operationalized as any of the following: subjective shortness of breath reported by patient or surrogate; tachypnea with respiratory rate ≥22 /minute; hypoxemia, defined as SpO2 <92% on room air, new receipt of supplemental oxygen to maintain SpO2 ≥92%, or increased supplemental oxygen to maintain SpO2 ≥92% for a patient on chronic oxygen therapy).

4. Sore throat

5. Anosmia

4. Laboratory-confirmed SARS (Severe acute respiratory syndrome-Coronavirus 2 (SARS CoV-2) infection within 10 days prior to randomization

5. Ability to manage own stool care

Exclusion Criteria:

1. Prisoner

2. Pregnancy

3. Breast feeding

4. Current infectious or noninfectious diarrheal illness

5. Unable to randomize within 21 days after onset of acute respiratory infection symptoms

6. Unable to randomize after hospital arrival

7. Colonic obstruction

8. Unresolved hypovolemia

9. CrCl <30ml/min

10. Hypermagnesemia

11. Diagnosis of Long QT syndrome

12. Known allergy to magnesium citrate or probiotic

13. Unresolved electrolyte imbalance such as hypokalemia or hypocalcemia. The patient can be enrolled if electrolytes are corrected and sustained.

14. Receipt of >1 dose of magnesium citrate or any other colonic cleanser in the 7 days prior to enrollment

15. Inability to receive enteral medications

16. Refusal or inability to be contacted on Day 15 for clinical outcome assessment if discharged prior to Day 15

17. Concurrent medical illness that interferes with clinical assessment Previous enrollment in this trial

18. The treating clinical team does not believe equipoise exists regarding the use of magnesium citrate plus a probiotic for the treatment of this patient.

19. Participating in any other COVID-19 therapeutic trial

20. Allergic to soy.

21. Lactose intolerant.