"CHANGE COVID-19 Severity"

NCT04941703 | Terminated Phase 1 Results DMC FDA Drug

• 1 other identifier: 210598
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19 Infection

Outcome Measures

Primary Outcomes (1)

• 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 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, dialysis or ECMO 10. = Dead

  Baseline through Day 7 after completion of therapy

Secondary Outcomes (1)

• Change in Oxygen Requirements From Baseline to Day 7 by Treatment Group

  baseline and 7 days

Study Arms (2)

Magnesium Citrate plus a Probiotic Arm:

EXPERIMENTAL

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.

Drug: Magnesium Citrate plus probiotic

Placebo

PLACEBO COMPARATOR

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.

Drug: Magnesium Citrate plus probiotic

Interventions

Magnesium Citrate plus probiotic DRUG

296 ml magnesium citrate

Magnesium Citrate plus a Probiotic Arm:; Placebo

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

COVID-19

Interventions

magnesium citrate; Probiotics

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Results Point of Contact

• Title: Wonder Drake
• Organization: University of Maryland School of Medicine

WDrake@som.umaryland.edu

410-710-1412

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Wonder Drake, MD

Model Details: Blinded, single-center, placebo-controlled randomized clinical trial

Study Record Dates

• First Submitted: June 24, 2021
• First Posted: June 28, 2021
• Study Start: November 4, 2021
• Primary Completion: June 25, 2022
• Study Completion: June 25, 2022
• Last Updated: November 13, 2023
• Results First Posted: November 13, 2023

Record last verified: 2023-11

Locations

US (1)