Trial Outcomes & Findings for Metabolic Effects of Hydroxychloroquine (NCT NCT02026232)
NCT ID: NCT02026232
Last Updated: 2023-12-28
Results Overview
determined by fasting blood glucose performed at baseline and follow-up
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
21 participants
Primary outcome timeframe
4 weeks
Results posted on
2023-12-28
Participant Flow
Two participants withdrew consent prior to the baseline visit. After the baseline visit, participants were randomized to either the hydroxychloroquine group or the placebo group.
Participant milestones
| Measure |
Hydroxychloroquine
hydroxychloroquine twice daily for 4 weeks
Hydroxychloroquine: 200mg twice daily
|
Placebo
hydroxychloroquine placebo twice daily for 4 weeks
Hydroxychloroquine Placebo: 200mg placebo twice daily
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
11
|
|
Overall Study
COMPLETED
|
7
|
9
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
| Measure |
Hydroxychloroquine
hydroxychloroquine twice daily for 4 weeks
Hydroxychloroquine: 200mg twice daily
|
Placebo
hydroxychloroquine placebo twice daily for 4 weeks
Hydroxychloroquine Placebo: 200mg placebo twice daily
|
|---|---|---|
|
Overall Study
incomplete visit/missing data
|
3
|
2
|
Baseline Characteristics
Metabolic Effects of Hydroxychloroquine
Baseline characteristics by cohort
| Measure |
Hydroxychloroquine
n=7 Participants
hydroxychloroquine twice daily for 4 weeks
Hydroxychloroquine: 200mg twice daily
|
Placebo
n=9 Participants
hydroxychloroquine placebo twice daily for 4 weeks
Hydroxychloroquine Placebo: 200mg placebo twice daily
|
Total
n=16 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
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Age, Continuous
|
55 years
STANDARD_DEVIATION 14 • n=5 Participants
|
61 years
STANDARD_DEVIATION 7 • n=7 Participants
|
59 years
STANDARD_DEVIATION 10 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4 weeksPopulation: randomized participants
determined by fasting blood glucose performed at baseline and follow-up
Outcome measures
| Measure |
Hydroxychloroquine
n=7 Participants
hydroxychloroquine twice daily for 4 weeks
Hydroxychloroquine: 200mg twice daily
|
Placebo
n=9 Participants
hydroxychloroquine placebo twice daily for 4 weeks
Hydroxychloroquine Placebo: 200mg placebo twice daily
|
|---|---|---|
|
Effect of HCQ on Fasting Blood Glucose
Baseline Glucose (mg/dL)
|
186.9 mg/dL
Standard Deviation 64.5
|
163.1 mg/dL
Standard Deviation 22.5
|
|
Effect of HCQ on Fasting Blood Glucose
Follow-up Glucose (mg/dL)
|
165.9 mg/dL
Standard Deviation 67.1
|
158.8 mg/dL
Standard Deviation 38.7
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: Randomized Participants
determined by lipid profile with calculated LDL performed at baseline and follow-up
Outcome measures
| Measure |
Hydroxychloroquine
n=7 Participants
hydroxychloroquine twice daily for 4 weeks
Hydroxychloroquine: 200mg twice daily
|
Placebo
n=9 Participants
hydroxychloroquine placebo twice daily for 4 weeks
Hydroxychloroquine Placebo: 200mg placebo twice daily
|
|---|---|---|
|
Effect of HCQ on Fasting Low Density Lipoprotein
Baseline - LDL (mg/dL)
|
90.4 mg/dL
Standard Deviation 21.4
|
92.8 mg/dL
Standard Deviation 26.2
|
|
Effect of HCQ on Fasting Low Density Lipoprotein
Follow-up - LDL (mg/dL)
|
72.4 mg/dL
Standard Deviation 21.6
|
87.7 mg/dL
Standard Deviation 23.8
|
Adverse Events
Hydroxychloroquine
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Hydroxychloroquine
n=10 participants at risk
hydroxychloroquine twice daily for 4 weeks
Hydroxychloroquine: 200mg twice daily
|
Placebo
n=11 participants at risk
hydroxychloroquine placebo twice daily for 4 weeks
Hydroxychloroquine Placebo: 200mg placebo twice daily
|
|---|---|---|
|
Blood and lymphatic system disorders
Drop in hematocrit
|
30.0%
3/10 • Number of events 3 • Adverse events will be monitored during the study -- approximately 1 month of study participation
|
9.1%
1/11 • Number of events 1 • Adverse events will be monitored during the study -- approximately 1 month of study participation
|
Additional Information
Dr. Janet McGill
Washington University School of Medicine
Phone: 314-273-3929
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place