"CHANGE COVID-19 Severity"

COVID-19 Infection Clinical Trial

— CHANGE  

Official title:

Investigation of Choice Alteration of the Gut Metagenome on COVID-19 Severity

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04941703
• Other study ID #: 210598
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: November 4, 2021
• Est. completion date: June 25, 2022

Study information

• Verified date: November 2023
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 23
• Est. completion date: June 25, 2022
• Est. primary completion date: June 25, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• COVID-19 Infection

Intervention

Drug:
• Magnesium Citrate plus probiotic
296 ml magnesium citrate

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	COVID Ordinal Outcome Scale	Outcome measured clinical status of the participant defined by the COVID Ordinal Outcome Scale on Day 7: 0 = Uninfected, no viral RNA detected; = Asymptomatic, viral RNA detected; = Symptomatic, independent; = Symptomatic, assistance needed; = Hospitalized, no oxygen needed; = Hospitalized, oxygen by mask or nasal prongs; = Hospitalized, oxygen by NIV or high flow; = Intubation and mechanical ventilation, pO2/FiO2 =150 or SpO2/FiO2 =200; = Mechanical ventilation, pO2/FiO2 <150 (SpO2/FiO2 <200) or vasopressors; = Mechanical ventilation, pO2/FiO2 <150 and vasopressors, dialysis or ECMO; = Dead	Baseline through Day 7 after completion of therapy
Secondary	Change in Oxygen Requirements From Baseline to Day 7 by Treatment Group	Measured by liters of oxygen per minute to maintain saturation above 90%	baseline and 7 days