"CHANGE COVID-19 Severity"

NCT ID: NCT04941703

Last Updated: 2023-11-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-04
• Study Completion Date: 2022-06-25

Brief 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.

Detailed Description

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. Patients, treating clinicians, and study personnel will all be blinded to study group assignment.

This research study is being done to determine if taking oral magnesium citrate and a probiotic will improve the outcome of adults hospitalized with COVID-19. In this study, half of the participants will receive magnesium citrate plus a probiotic and half will receive a placebo randomized 1:1. You will be placed in one of these 2 groups randomly, like the flip of a coin. The investigational arm will receive one 10 oz. bottle of magnesium citrate to drink once and 2 oral probiotic capsules to be taken twice a day for 6 days. We will also collect a blood sample on Day 1 and Day 7 for CD4+ and CD8+ evaluation and will be collecting data on each participants COVID-19 infection progression during hospitalization.

Assessments for this study will be done on day 7 and day 29 if the participant is still hospitalized at those time points. If they have been discharged from the hospital before these assessments, we will do these by phone. Each participant will also be contacted at 3 months to assess how they are doing. There will be no compensation for taking part in this study.

Conditions

COVID-19 Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Magnesium Citrate plus a Probiotic Arm:

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 Type: EXPERIMENTAL

Magnesium Citrate plus probiotic

Intervention Type: DRUG

296 ml magnesium citrate

Placebo

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.

Group Type: PLACEBO_COMPARATOR

Magnesium Citrate plus probiotic

Intervention Type: DRUG

296 ml magnesium citrate

Interventions

Magnesium Citrate plus probiotic

296 ml magnesium citrate

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vanderbilt University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Wonder Drake

Wonder Drake, MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

210598

Identifier Type: -

Identifier Source: org_study_id