Ignite Creation Date:
2025-12-24 @ 7:42 PM
Ignite Modification Date:
2025-12-30 @ 7:42 PM
Study NCT ID:
NCT04941703
Status:
TERMINATED
Last Update Posted:
2023-11-13
First Post:
2021-06-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
"CHANGE COVID-19 Severity"
Sponsor:
Vanderbilt University Medical Center
Organization:
Study Overview
Official Title:
Investigation of Choice Alteration of the Gut Metagenome on COVID-19 Severity
Status:
TERMINATED
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Recruitment issues after COVID-19 abated; not enough hypoxic patients to meet criteria.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CHANGE
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: