Trial Outcomes & Findings for Ubiquinol (Reduced COQ10) for Patients With Sepsis (NCT NCT01948063)
NCT ID: NCT01948063
Last Updated: 2017-04-24
Results Overview
Total CoQ10 levels (mcg/mL) at 24 hours post study drug admission.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
38 participants
Primary outcome timeframe
24 hours after study drug administration
Results posted on
2017-04-24
Participant Flow
1 patient was randomized in the placebo group but the blood was accidentally thawed why this patient was excluded. 2 patients were randomized in the Ubiquinol group but never received the treatment (one because of an exclusion criteria and one because of a Boston-wide mass casualty event). These were also excluded.
Participant milestones
| Measure |
Placebo
Depending on the patient's ability to swallow pills, patients in the control group will receive a placebo pill or a liquid placebo, which is 50 milliliters of Ensure (a dietary supplement). This will be given every 12 hours for 7 days or until hospital discharge.
|
Ubiquinol
Depending on the patient's ability to swallow pills, patients in the experimental group will receive 200mg of Ubiquinol in either a pill or a liquid. The liquid form of the study med will be mixed with 50 milliliters of Ensure (a dietary supplement) to ensure blinding. This will be given every 12 hours for 7 days or until hospital discharge.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
21
|
|
Overall Study
COMPLETED
|
19
|
19
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
Placebo
Depending on the patient's ability to swallow pills, patients in the control group will receive a placebo pill or a liquid placebo, which is 50 milliliters of Ensure (a dietary supplement). This will be given every 12 hours for 7 days or until hospital discharge.
|
Ubiquinol
Depending on the patient's ability to swallow pills, patients in the experimental group will receive 200mg of Ubiquinol in either a pill or a liquid. The liquid form of the study med will be mixed with 50 milliliters of Ensure (a dietary supplement) to ensure blinding. This will be given every 12 hours for 7 days or until hospital discharge.
|
|---|---|---|
|
Overall Study
Boston MCI halted research protocol
|
0
|
1
|
|
Overall Study
Discovered an enrollment in other study
|
0
|
1
|
|
Overall Study
Blood samples were accidentally thawed
|
1
|
0
|
Baseline Characteristics
Ubiquinol (Reduced COQ10) for Patients With Sepsis
Baseline characteristics by cohort
| Measure |
Placebo
n=19 Participants
Patients will receive a placebo pill or a liquid placebo. The liquid placebo is 50 milliliters of Ensure (a dietary supplement). Placebo will be given every 12 hours for 7 days or until hospital discharge.
|
Ubiquinol
n=19 Participants
Patients will receive 200mg of Ubiquinol in either a pill or a liquid. The liquid form of the study med will be mixed with 50 milliliters of Ensure (a dietary supplement) to ensure blinding. This will be given every 12 hours for 7 days or until hospital discharge.
|
Total
n=38 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64 Years
STANDARD_DEVIATION 14 • n=99 Participants
|
60 Years
STANDARD_DEVIATION 18 • n=107 Participants
|
62 Years
STANDARD_DEVIATION 15 • n=206 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
19 participants
n=99 Participants
|
19 participants
n=107 Participants
|
38 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 24 hours after study drug administrationTotal CoQ10 levels (mcg/mL) at 24 hours post study drug admission.
Outcome measures
| Measure |
Placebo
n=19 Participants
Patients will receive a placebo pill or a liquid placebo. The liquid placebo is 50 milliliters of Ensure (a dietary supplement). Placebo will be given every 12 hours for 7 days or until hospital discharge.
|
Ubiquinol
n=19 Participants
Patients will receive 200mg of Ubiquinol in either a pill or a liquid. The liquid form of the study med will be mixed with 50 milliliters of Ensure (a dietary supplement) to ensure blinding. This will be given every 12 hours for 7 days or until hospital discharge.
|
|---|---|---|
|
CoQ10 Levels
|
0.38 (mcg/mL)
Interval 0.26 to 0.66
|
0.87 (mcg/mL)
Interval 0.57 to 1.26
|
Adverse Events
Ubiquinol
Serious events: 0 serious events
Other events: 1 other events
Deaths: 4 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 2 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Ubiquinol
n=19 participants at risk
Depending on the patient's ability to swallow pills, patients in the experimental group will receive 200mg of Ubiquinol in either a pill or a liquid. The liquid form of the study med will be mixed with 50 milliliters of Ensure (a dietary supplement) to ensure blinding. This will be given every 12 hours for 7 days or until hospital discharge.
|
Placebo
n=19 participants at risk
Depending on the patient's ability to swallow pills, patients in the control group will receive a placebo pill or a liquid placebo, which is 50 milliliters of Ensure (a dietary supplement). This will be given every 12 hours for 7 days or until hospital discharge.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
5.3%
1/19 • Number of events 1 • Hospital stay, average 10 days
|
0.00%
0/19 • Hospital stay, average 10 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place