Trial Outcomes & Findings for "CHANGE COVID-19 Severity" (NCT NCT04941703)
NCT ID: NCT04941703
Last Updated: 2023-11-13
Results Overview
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
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
23 participants
Primary outcome timeframe
Baseline through Day 7 after completion of therapy
Results posted on
2023-11-13
Participant Flow
Participant milestones
| Measure |
Magnesium Citrate Plus a Probiotic Arm:
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.
Magnesium Citrate plus probiotic: 296 ml magnesium citrate
|
Placebo
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.
Magnesium Citrate plus probiotic: 296 ml magnesium citrate
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
10
|
|
Overall Study
COMPLETED
|
8
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
"CHANGE COVID-19 Severity"
Baseline characteristics by cohort
| Measure |
Magnesium Citrate Plus a Probiotic Arm:
n=8 Participants
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.
Magnesium Citrate plus probiotic: 296 ml magnesium citrate
|
Placebo
n=10 Participants
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.
Magnesium Citrate plus probiotic: 296 ml magnesium citrate
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Age, Continuous
|
67.5 years
n=5 Participants
|
62.0 years
n=7 Participants
|
66.0 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=5 Participants
|
10 participants
n=7 Participants
|
18 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline through Day 7 after completion of therapyPopulation: 2 Participants in the Magnesium Citrate arm and 3 participants in the placebo arm were discharged prior to Day 7. No data was collected from them for this outcome measure
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
Outcome measures
| Measure |
Magnesium Citrate Plus a Probiotic Arm:
n=6 Participants
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.
Magnesium Citrate plus probiotic: 296 ml magnesium citrate
|
Placebo
n=7 Participants
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.
Magnesium Citrate plus probiotic: 296 ml magnesium citrate
|
|---|---|---|
|
COVID Ordinal Outcome Scale
Outcome Score = 0
|
0 Participants
|
0 Participants
|
|
COVID Ordinal Outcome Scale
Outcome Score = 1
|
0 Participants
|
0 Participants
|
|
COVID Ordinal Outcome Scale
Outcome Score = 2
|
1 Participants
|
1 Participants
|
|
COVID Ordinal Outcome Scale
Outcome Score = 4
|
0 Participants
|
0 Participants
|
|
COVID Ordinal Outcome Scale
Outcome Score = 5
|
1 Participants
|
1 Participants
|
|
COVID Ordinal Outcome Scale
Outcome Score = 6
|
2 Participants
|
4 Participants
|
|
COVID Ordinal Outcome Scale
Outcome Score = 7
|
0 Participants
|
0 Participants
|
|
COVID Ordinal Outcome Scale
Outcome Score = 8
|
0 Participants
|
0 Participants
|
|
COVID Ordinal Outcome Scale
Outcome Score = 9
|
0 Participants
|
0 Participants
|
|
COVID Ordinal Outcome Scale
Outcome Score = 10
|
0 Participants
|
0 Participants
|
|
COVID Ordinal Outcome Scale
Outcome Score = 3
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: baseline and 7 daysMeasured by liters of oxygen per minute to maintain saturation above 90%
Outcome measures
| Measure |
Magnesium Citrate Plus a Probiotic Arm:
n=6 Participants
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.
Magnesium Citrate plus probiotic: 296 ml magnesium citrate
|
Placebo
n=7 Participants
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.
Magnesium Citrate plus probiotic: 296 ml magnesium citrate
|
|---|---|---|
|
Change in Oxygen Requirements From Baseline to Day 7 by Treatment Group
|
2.00 liters per minute
Interval 0.0 to 6.0
|
9.00 liters per minute
Interval 5.0 to 15.0
|
Adverse Events
Magnesium Citrate Plus a Probiotic Arm:
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place