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NCT04941703: CHANGE

"CHANGE COVID-19 Severity"

Terminated Phase 1, PHASE2 Results posted Last updated 13 November 2023
What this trial tests

Phase 1, PHASE2 trial testing Magnesium Citrate plus probiotic in COVID-19 Infection in 23 participants. Terminated before completion.

Timeline
4 November 2021
Primary endpoint
25 June 2022
25 June 2022

Quick facts

Lead sponsorVanderbilt University Medical Center
PhasePhase 1, PHASE2
StatusTerminated
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposetreatment
Enrollment23
Start date4 November 2021
Primary completion25 June 2022
Estimated completion25 June 2022
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Vanderbilt University Medical Center

Who can join

Adults 18 to 99, any sex, with COVID-19 Infection. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

COVID Ordinal Outcome Scale Primary · Baseline through Day 7 after completion of therapy

Outcome measured clinical status of the participant defined by the COVID Ordinal Outcome Scale on Day 7: 0 = Uninfected, no viral RNA detected 1. = Asymptomatic, viral RNA detected 2. = Symptomatic, independent 3. = Symptomatic, assistance needed 4. = Hospitalized, no oxygen needed 5. = Hospitalized, oxygen by mask or nasal prongs 6. = Hospitalized, oxygen by NIV or high flow 7. = Intubation and mechanical ventilation, pO2/FiO2 ≥150 or SpO2/FiO2 ≥200 8. = Mechanical ventilation, pO2/FiO2 \<150 (SpO2/FiO2 \<200) or vasopressors 9. = Mechanical ventilation, pO2/FiO2 \<150 and vasopressors, dia

Outcome Score = 0
GroupValue95% CI
Magnesium Citrate Plus a Probiotic Arm:0
Placebo0
Outcome Score = 1
GroupValue95% CI
Magnesium Citrate Plus a Probiotic Arm:0
Placebo0
Outcome Score = 2
GroupValue95% CI
Magnesium Citrate Plus a Probiotic Arm:1
Placebo1
Outcome Score = 3
GroupValue95% CI
Magnesium Citrate Plus a Probiotic Arm:2
Placebo1
Outcome Score = 4
GroupValue95% CI
Magnesium Citrate Plus a Probiotic Arm:0
Placebo0
Outcome Score = 5
GroupValue95% CI
Magnesium Citrate Plus a Probiotic Arm:1
Placebo1
Outcome Score = 6
GroupValue95% CI
Magnesium Citrate Plus a Probiotic Arm:2
Placebo4
Outcome Score = 7
GroupValue95% CI
Magnesium Citrate Plus a Probiotic Arm:0
Placebo0
Change in Oxygen Requirements From Baseline to Day 7 by Treatment Group Secondary · baseline and 7 days

Measured by liters of oxygen per minute to maintain saturation above 90%

GroupValue95% CI
Magnesium Citrate Plus a Probiotic Arm:2.000 – 6
Placebo9.005.00 – 15.00

Sponsor's own 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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Evidences and perspectives of the use of probiotics, prebiotics, synbiotics, and postbiotics as adjuvants for prevention and treatment of COVID-19: A bibliometric analysis and systematic review.
    Xavier-Santos D, Padilha M, Fabiano GA, Vinderola G, et al · · 2022 · cited 76× · PMID 35002079 · DOI 10.1016/j.tifs.2021.12.033
  2. Probiotics and prebiotics: potential prevention and therapeutic target for nutritional management of COVID-19?
    Batista KS, de Albuquerque JG, Vasconcelos MHA, Bezerra MLR, et al · · 2023 · cited 33× · PMID 34668465 · DOI 10.1017/s0954422421000317
  3. Targeting the Gut Microbiota in Coronavirus Disease 2019: Hype or Hope?
    Lau HC, Ng SC, Yu J. · · 2022 · cited 16× · PMID 34508775 · DOI 10.1053/j.gastro.2021.09.009
  4. COVID-19 and Gut Injury.
    Shen S, Gong M, Wang G, Dua K, et al · · 2022 · cited 12× · PMID 36297092 · DOI 10.3390/nu14204409
  5. The Roles and Pathogenesis Mechanisms of a Number of Micronutrients in the Prevention and/or Treatment of Chronic Hepatitis, COVID-19 and Type-2 Diabetes Mellitus.
    Sumaily KM. · · 2022 · cited 9× · PMID 35807813 · DOI 10.3390/nu14132632
  6. Elements and COVID-19: A Comprehensive Overview of Studies on Their Blood/Urinary Levels and Supplementation with an Update on Clinical Trials.
    Ścibior A, Wnuk E. · · 2022 · cited 5× · PMID 35205082 · DOI 10.3390/biology11020215
  7. Nutraceuticals and pharmacological to balance the transitional microbiome to extend immunity during COVID-19 and other viral infections.
    Kaushal A. · · 2024 · cited 2× · PMID 39294611 · DOI 10.1186/s12967-024-05587-9
  8. Corrigendum to 'Evidences and perspectives of the use of probiotics, prebiotics, synbiotics, and postbiotics as adjuvants for prevention and treatment of COVID-19: A bibliometric analysis and integrative review' [Trends in Food Science & Technology 120 (2022) 174-192].
    Xavier-Santos D, Padilha M, Fabiano GA, Vinderola G, et al · · 2022 · cited 2× · PMID 35125655 · DOI 10.1016/j.tifs.2022.01.028

Verify or expand the search:

Other recruiting trials for COVID-19 Infection

Currently open trials in the same condition.

Other Vanderbilt University Medical Center trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04941703.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing