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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04941703
Other study ID # 210598
Secondary ID
Status Terminated
Phase Phase 1/Phase 2
First received
Last updated
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
Health authority
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.


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Study Design


Related Conditions & MeSH terms


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
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