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"CHANGE COVID-19 Severity" (CHANGE)

Primary Purpose

COVID-19 Infection

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Magnesium Citrate plus probiotic
Sponsored by
Vanderbilt University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19 Infection

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Vanderbilt University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Magnesium Citrate plus a Probiotic Arm:

Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in COVID Ordinal Outcome Scale
Scoring Criteria 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

Secondary Outcome Measures

Full Information

First Posted
June 24, 2021
Last Updated
November 11, 2022
Sponsor
Vanderbilt University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04941703
Brief Title
"CHANGE COVID-19 Severity"
Acronym
CHANGE
Official Title
Investigation of Choice Alteration of the Gut Metagenome on COVID-19 Severity
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Terminated
Why Stopped
Recruitment issues after COVID-19 abated; not enough hypoxic patients to meet criteria.
Study Start Date
November 4, 2021 (Actual)
Primary Completion Date
June 25, 2022 (Actual)
Study Completion Date
June 25, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19 Infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Blinded, single-center, placebo-controlled randomized clinical trial
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Magnesium Citrate plus a Probiotic Arm:
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Magnesium Citrate plus probiotic
Intervention Description
296 ml magnesium citrate
Primary Outcome Measure Information:
Title
Change in COVID Ordinal Outcome Scale
Description
Scoring Criteria 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
Time Frame
Baseline through Day 7 after completion of therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥18 years Currently hospitalized or in an emergency department with anticipated hospitalization. Symptoms of acute respiratory infection, defined as one or more of the following: Cough Fever (> 37.5° C / 99.5° F) 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). Sore throat Anosmia Laboratory-confirmed SARS (Severe acute respiratory syndrome-Coronavirus 2 (SARS CoV-2) infection within 10 days prior to randomization Ability to manage own stool care Exclusion Criteria: Prisoner Pregnancy Breast feeding Current infectious or noninfectious diarrheal illness Unable to randomize within 21 days after onset of acute respiratory infection symptoms Unable to randomize after hospital arrival Colonic obstruction Unresolved hypovolemia CrCl <30ml/min Hypermagnesemia Diagnosis of Long QT syndrome Known allergy to magnesium citrate or probiotic Unresolved electrolyte imbalance such as hypokalemia or hypocalcemia. The patient can be enrolled if electrolytes are corrected and sustained. Receipt of >1 dose of magnesium citrate or any other colonic cleanser in the 7 days prior to enrollment Inability to receive enteral medications Refusal or inability to be contacted on Day 15 for clinical outcome assessment if discharged prior to Day 15 Concurrent medical illness that interferes with clinical assessment Previous enrollment in this trial The treating clinical team does not believe equipoise exists regarding the use of magnesium citrate plus a probiotic for the treatment of this patient. Participating in any other COVID-19 therapeutic trial Allergic to soy. Lactose intolerant.
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States

12. IPD Sharing Statement

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"CHANGE COVID-19 Severity"

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