Trial Outcomes & Findings for CHOlesterol Lowering and Residual Risk in Type 2 Diabetes (NCT NCT04369664)
NCT ID: NCT04369664
Last Updated: 2024-10-17
Results Overview
The difference in platelet activity will be assessed by measuring changes in monocyte-platelet aggregates. Monocyte platelet aggregates (MPA) are a robust marker of platelet activity and inflammatory monocytes. The difference in platelet activity before and after cholesterol reduction will be compared using paired t-test or Wilcoxon signed-rank test. The study will also perform a linear mixed model for the multivariate analysis; the primary outcome will be the change in platelet activity (MPA) before and after cholesterol reduction. All tests will be 2-tailed, and a P \<0.05 will be considered as statistically significant. A positive MPA value indicates increased platelet activity, while a negative MPA value indicates decreased platelet activity.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
151 participants
Primary outcome timeframe
Baseline visit, Follow up visit (4 weeks)
Results posted on
2024-10-17
Participant Flow
Participant milestones
| Measure |
Type 2 Diabetes Group
All participants with type 2 diabetes will be given cholesterol-lowering medicine (evolocumab (PCSK9 inhibitor) plus atorvastatin (statin) or ezetimibe (zetia)) for 1 month with the same risk factors being measured following cholesterol reduction. They will be asked to undergo blood draw, to receive study medication, and to undergo additional optional vascular health testing including endothelial cell harvesting and glycocalyx (tongue probe).
Statin: Participants will be given up to 80 mg oral tablets daily for the entire study period preferably at the same time each day.
PCSK9 inhibitor: Participants will receive 2 injections of 140 mg of PCSK9 inhibitor, one will be administered at baseline visit and the other will be self-administered 2 weeks later at home.
Ezetimibe 10mg: Participants who are not able to or not willing to take atorvastatin will be given 10 mg ezetimibe oral tablets daily for the entire study period preferably at the same time each day.
|
Control Group
The participants in the control group are subjects with elevated cholesterol who do not have diabetes. All participants will be given cholesterol-lowering medicines (evolocumab (PCSK9 inhibitor) plus atorvastatin (statin) or ezetimibe (zetia)) for 1 month with the same risk factors being measured following cholesterol reduction. They will be asked to undergo blood draw, to receive study medication, and to undergo additional optional vascular health testing including endothelial cell harvesting and glycocalyx (tongue probe).
Statin: Participants will be given up to 80 mg oral tablets daily for the entire study period preferably at the same time each day.
PCSK9 inhibitor: Participants will receive 2 injections of 140 mg of PCSK9 inhibitor, one will be administered at baseline visit and the other will be self-administered 2 weeks later at home.
Ezetimibe 10mg: Participants who are not able to or not willing to take atorvastatin will be given 10 mg ezetimibe oral tablets daily for the entire study period preferably at the same time each day.
|
|---|---|---|
|
Overall Study
STARTED
|
76
|
75
|
|
Overall Study
COMPLETED
|
75
|
75
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Type 2 Diabetes Group
All participants with type 2 diabetes will be given cholesterol-lowering medicine (evolocumab (PCSK9 inhibitor) plus atorvastatin (statin) or ezetimibe (zetia)) for 1 month with the same risk factors being measured following cholesterol reduction. They will be asked to undergo blood draw, to receive study medication, and to undergo additional optional vascular health testing including endothelial cell harvesting and glycocalyx (tongue probe).
Statin: Participants will be given up to 80 mg oral tablets daily for the entire study period preferably at the same time each day.
PCSK9 inhibitor: Participants will receive 2 injections of 140 mg of PCSK9 inhibitor, one will be administered at baseline visit and the other will be self-administered 2 weeks later at home.
Ezetimibe 10mg: Participants who are not able to or not willing to take atorvastatin will be given 10 mg ezetimibe oral tablets daily for the entire study period preferably at the same time each day.
|
Control Group
The participants in the control group are subjects with elevated cholesterol who do not have diabetes. All participants will be given cholesterol-lowering medicines (evolocumab (PCSK9 inhibitor) plus atorvastatin (statin) or ezetimibe (zetia)) for 1 month with the same risk factors being measured following cholesterol reduction. They will be asked to undergo blood draw, to receive study medication, and to undergo additional optional vascular health testing including endothelial cell harvesting and glycocalyx (tongue probe).
Statin: Participants will be given up to 80 mg oral tablets daily for the entire study period preferably at the same time each day.
PCSK9 inhibitor: Participants will receive 2 injections of 140 mg of PCSK9 inhibitor, one will be administered at baseline visit and the other will be self-administered 2 weeks later at home.
Ezetimibe 10mg: Participants who are not able to or not willing to take atorvastatin will be given 10 mg ezetimibe oral tablets daily for the entire study period preferably at the same time each day.
|
|---|---|---|
|
Overall Study
Physician Decision
|
1
|
0
|
Baseline Characteristics
CHOlesterol Lowering and Residual Risk in Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
Type 2 Diabetes Group
n=75 Participants
All participants with type 2 diabetes will be given cholesterol-lowering medicine (evolocumab (PCSK9 inhibitor) plus atorvastatin (statin) or ezetimibe (zetia)) for 1 month with the same risk factors being measured following cholesterol reduction. They will be asked to undergo blood draw, to receive study medication, and to undergo additional optional vascular health testing including endothelial cell harvesting and glycocalyx (tongue probe).
Statin: Participants will be given up to 80 mg oral tablets daily for the entire study period preferably at the same time each day.
PCSK9 inhibitor: Participants will receive 2 injections of 140 mg of PCSK9 inhibitor, one will be administered at baseline visit and the other will be self-administered 2 weeks later at home.
Ezetimibe 10mg: Participants who are not able to or not willing to take atorvastatin will be given 10 mg ezetimibe oral tablets daily for the entire study period preferably at the same time each day.
|
Control Group
n=75 Participants
The participants in the control group are subjects with elevated cholesterol who do not have diabetes. All participants will be given cholesterol-lowering medicines (evolocumab (PCSK9 inhibitor) plus atorvastatin (statin) or ezetimibe (zetia)) for 1 month with the same risk factors being measured following cholesterol reduction. They will be asked to undergo blood draw, to receive study medication, and to undergo additional optional vascular health testing including endothelial cell harvesting and glycocalyx (tongue probe).
Statin: Participants will be given up to 80 mg oral tablets daily for the entire study period preferably at the same time each day.
PCSK9 inhibitor: Participants will receive 2 injections of 140 mg of PCSK9 inhibitor, one will be administered at baseline visit and the other will be self-administered 2 weeks later at home.
Ezetimibe 10mg: Participants who are not able to or not willing to take atorvastatin will be given 10 mg ezetimibe oral tablets daily for the entire study period preferably at the same time each day.
|
Total
n=150 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.2 years
STANDARD_DEVIATION 13.88 • n=5 Participants
|
47.72 years
STANDARD_DEVIATION 15.49 • n=7 Participants
|
49.96 years
STANDARD_DEVIATION 14.68 • n=5 Participants
|
|
Sex: Female, Male
Female
|
47 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
87 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
15 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
60 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
124 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
|
8 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
23 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
|
31 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
27 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
75 participants
n=5 Participants
|
75 participants
n=7 Participants
|
150 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline visit, Follow up visit (4 weeks)The difference in platelet activity will be assessed by measuring changes in monocyte-platelet aggregates. Monocyte platelet aggregates (MPA) are a robust marker of platelet activity and inflammatory monocytes. The difference in platelet activity before and after cholesterol reduction will be compared using paired t-test or Wilcoxon signed-rank test. The study will also perform a linear mixed model for the multivariate analysis; the primary outcome will be the change in platelet activity (MPA) before and after cholesterol reduction. All tests will be 2-tailed, and a P \<0.05 will be considered as statistically significant. A positive MPA value indicates increased platelet activity, while a negative MPA value indicates decreased platelet activity.
Outcome measures
| Measure |
Type 2 Diabetes Group
n=73 Participants
All participants with type 2 diabetes will be given cholesterol-lowering medicine (evolocumab (PCSK9 inhibitor) plus atorvastatin (statin) or ezetimibe (zetia)) for 1 month with the same risk factors being measured following cholesterol reduction. They will be asked to undergo blood draw, to receive study medication, and to undergo additional optional vascular health testing including endothelial cell harvesting and glycocalyx (tongue probe).
Statin: Participants will be given up to 80 mg oral tablets daily for the entire study period preferably at the same time each day.
PCSK9 inhibitor: Participants will receive 2 injections of 140 mg of PCSK9 inhibitor, one will be administered at baseline visit and the other will be self-administered 2 weeks later at home.
Ezetimibe 10mg: Participants who are not able to or not willing to take atorvastatin will be given 10 mg ezetimibe oral tablets daily for the entire study period preferably at the same time each day.
|
Control Group
n=71 Participants
The participants in the control group are subjects with elevated cholesterol who do not have diabetes. All participants will be given cholesterol-lowering medicines (evolocumab (PCSK9 inhibitor) plus atorvastatin (statin) or ezetimibe (zetia)) for 1 month with the same risk factors being measured following cholesterol reduction. They will be asked to undergo blood draw, to receive study medication, and to undergo additional optional vascular health testing including endothelial cell harvesting and glycocalyx (tongue probe).
Statin: Participants will be given up to 80 mg oral tablets daily for the entire study period preferably at the same time each day.
PCSK9 inhibitor: Participants will receive 2 injections of 140 mg of PCSK9 inhibitor, one will be administered at baseline visit and the other will be self-administered 2 weeks later at home.
Ezetimibe 10mg: Participants who are not able to or not willing to take atorvastatin will be given 10 mg ezetimibe oral tablets daily for the entire study period preferably at the same time each day.
|
|---|---|---|
|
Percent Change in Platelet Activity (MPA) Before and After Cholesterol Reduction
|
-5 percent change in platelet aggregation
Interval -24.0 to 37.0
|
-7 percent change in platelet aggregation
Interval -31.0 to 22.0
|
PRIMARY outcome
Timeframe: Baseline visit, Follow up visit (4 weeks)The difference in platelet activity will be assessed by using the light transmission aggregometry test (LTA). Light Transmission Aggregometry \[LTA\] is frequently undertaken as the first test of platelet function, as a screening test for a bleeding disorder and in addition for monitoring of anti-platelet drugs using platelet rich plasma (PRP). The difference in platelet activity before and after cholesterol reduction will be compared using paired t-test or Wilcoxon signed-rank test. We will also perform a linear mixed model for the multivariate analysis; the primary outcome will be the change in platelet activity (LTA) before and after cholesterol reduction. All tests will be 2-tailed, and a P \<0.05 will be considered as statistically significant. A positive value indicates increased platelet activity, while a negative value indicates decreased platelet activity.
Outcome measures
| Measure |
Type 2 Diabetes Group
n=73 Participants
All participants with type 2 diabetes will be given cholesterol-lowering medicine (evolocumab (PCSK9 inhibitor) plus atorvastatin (statin) or ezetimibe (zetia)) for 1 month with the same risk factors being measured following cholesterol reduction. They will be asked to undergo blood draw, to receive study medication, and to undergo additional optional vascular health testing including endothelial cell harvesting and glycocalyx (tongue probe).
Statin: Participants will be given up to 80 mg oral tablets daily for the entire study period preferably at the same time each day.
PCSK9 inhibitor: Participants will receive 2 injections of 140 mg of PCSK9 inhibitor, one will be administered at baseline visit and the other will be self-administered 2 weeks later at home.
Ezetimibe 10mg: Participants who are not able to or not willing to take atorvastatin will be given 10 mg ezetimibe oral tablets daily for the entire study period preferably at the same time each day.
|
Control Group
n=71 Participants
The participants in the control group are subjects with elevated cholesterol who do not have diabetes. All participants will be given cholesterol-lowering medicines (evolocumab (PCSK9 inhibitor) plus atorvastatin (statin) or ezetimibe (zetia)) for 1 month with the same risk factors being measured following cholesterol reduction. They will be asked to undergo blood draw, to receive study medication, and to undergo additional optional vascular health testing including endothelial cell harvesting and glycocalyx (tongue probe).
Statin: Participants will be given up to 80 mg oral tablets daily for the entire study period preferably at the same time each day.
PCSK9 inhibitor: Participants will receive 2 injections of 140 mg of PCSK9 inhibitor, one will be administered at baseline visit and the other will be self-administered 2 weeks later at home.
Ezetimibe 10mg: Participants who are not able to or not willing to take atorvastatin will be given 10 mg ezetimibe oral tablets daily for the entire study period preferably at the same time each day.
|
|---|---|---|
|
Percent Change in Platelet Activity (LTA) Before and After Cholesterol Reduction
|
-74 percent change in MPAs
Interval -91.0 to -66.0
|
-76 percent change in MPAs
Interval -84.0 to -69.0
|
Adverse Events
Type 2 Diabetes Group
Serious events: 0 serious events
Other events: 37 other events
Deaths: 0 deaths
Control Group
Serious events: 0 serious events
Other events: 30 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Type 2 Diabetes Group
n=75 participants at risk
All participants with type 2 diabetes will be given cholesterol-lowering medicine (evolocumab (PCSK9 inhibitor) plus atorvastatin (statin) or ezetimibe (zetia)) for 1 month with the same risk factors being measured following cholesterol reduction. They will be asked to undergo blood draw, to receive study medication, and to undergo additional optional vascular health testing including endothelial cell harvesting and glycocalyx (tongue probe).
Statin: Participants will be given up to 80 mg oral tablets daily for the entire study period preferably at the same time each day.
PCSK9 inhibitor: Participants will receive 2 injections of 140 mg of PCSK9 inhibitor, one will be administered at baseline visit and the other will be self-administered 2 weeks later at home.
Ezetimibe 10mg: Participants who are not able to or not willing to take atorvastatin will be given 10 mg ezetimibe oral tablets daily for the entire study period preferably at the same time each day.
|
Control Group
n=75 participants at risk
The participants in the control group are subjects with elevated cholesterol who do not have diabetes. All participants will be given cholesterol-lowering medicines (evolocumab (PCSK9 inhibitor) plus atorvastatin (statin) or ezetimibe (zetia)) for 1 month with the same risk factors being measured following cholesterol reduction. They will be asked to undergo blood draw, to receive study medication, and to undergo additional optional vascular health testing including endothelial cell harvesting and glycocalyx (tongue probe).
Statin: Participants will be given up to 80 mg oral tablets daily for the entire study period preferably at the same time each day.
PCSK9 inhibitor: Participants will receive 2 injections of 140 mg of PCSK9 inhibitor, one will be administered at baseline visit and the other will be self-administered 2 weeks later at home.
Ezetimibe 10mg: Participants who are not able to or not willing to take atorvastatin will be given 10 mg ezetimibe oral tablets daily for the entire study period preferably at the same time each day.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
10.7%
8/75 • 1 month
Participants were asked about side effects/any changes in health during weekly follow-up phone calls and during follow-up visit(s). Feedback from participants was recorded in the case report form and discussed with PI during weekly team meetings and/or immediately if participant had an urgent concern.
|
8.0%
6/75 • 1 month
Participants were asked about side effects/any changes in health during weekly follow-up phone calls and during follow-up visit(s). Feedback from participants was recorded in the case report form and discussed with PI during weekly team meetings and/or immediately if participant had an urgent concern.
|
|
General disorders
Muscle Cramps
|
12.0%
9/75 • 1 month
Participants were asked about side effects/any changes in health during weekly follow-up phone calls and during follow-up visit(s). Feedback from participants was recorded in the case report form and discussed with PI during weekly team meetings and/or immediately if participant had an urgent concern.
|
9.3%
7/75 • 1 month
Participants were asked about side effects/any changes in health during weekly follow-up phone calls and during follow-up visit(s). Feedback from participants was recorded in the case report form and discussed with PI during weekly team meetings and/or immediately if participant had an urgent concern.
|
|
Skin and subcutaneous tissue disorders
Site Injection Discomfort or Reaction
|
6.7%
5/75 • 1 month
Participants were asked about side effects/any changes in health during weekly follow-up phone calls and during follow-up visit(s). Feedback from participants was recorded in the case report form and discussed with PI during weekly team meetings and/or immediately if participant had an urgent concern.
|
5.3%
4/75 • 1 month
Participants were asked about side effects/any changes in health during weekly follow-up phone calls and during follow-up visit(s). Feedback from participants was recorded in the case report form and discussed with PI during weekly team meetings and/or immediately if participant had an urgent concern.
|
|
General disorders
Flu Like Symptoms
|
8.0%
6/75 • 1 month
Participants were asked about side effects/any changes in health during weekly follow-up phone calls and during follow-up visit(s). Feedback from participants was recorded in the case report form and discussed with PI during weekly team meetings and/or immediately if participant had an urgent concern.
|
4.0%
3/75 • 1 month
Participants were asked about side effects/any changes in health during weekly follow-up phone calls and during follow-up visit(s). Feedback from participants was recorded in the case report form and discussed with PI during weekly team meetings and/or immediately if participant had an urgent concern.
|
|
Nervous system disorders
Headache
|
4.0%
3/75 • 1 month
Participants were asked about side effects/any changes in health during weekly follow-up phone calls and during follow-up visit(s). Feedback from participants was recorded in the case report form and discussed with PI during weekly team meetings and/or immediately if participant had an urgent concern.
|
1.3%
1/75 • 1 month
Participants were asked about side effects/any changes in health during weekly follow-up phone calls and during follow-up visit(s). Feedback from participants was recorded in the case report form and discussed with PI during weekly team meetings and/or immediately if participant had an urgent concern.
|
|
Ear and labyrinth disorders
Dizziness
|
0.00%
0/75 • 1 month
Participants were asked about side effects/any changes in health during weekly follow-up phone calls and during follow-up visit(s). Feedback from participants was recorded in the case report form and discussed with PI during weekly team meetings and/or immediately if participant had an urgent concern.
|
2.7%
2/75 • 1 month
Participants were asked about side effects/any changes in health during weekly follow-up phone calls and during follow-up visit(s). Feedback from participants was recorded in the case report form and discussed with PI during weekly team meetings and/or immediately if participant had an urgent concern.
|
|
General disorders
Other symptoms of upset stomach (Including nausea, indigestion or constipation)
|
8.0%
6/75 • 1 month
Participants were asked about side effects/any changes in health during weekly follow-up phone calls and during follow-up visit(s). Feedback from participants was recorded in the case report form and discussed with PI during weekly team meetings and/or immediately if participant had an urgent concern.
|
5.3%
4/75 • 1 month
Participants were asked about side effects/any changes in health during weekly follow-up phone calls and during follow-up visit(s). Feedback from participants was recorded in the case report form and discussed with PI during weekly team meetings and/or immediately if participant had an urgent concern.
|
|
General disorders
Fatigue
|
4.0%
3/75 • 1 month
Participants were asked about side effects/any changes in health during weekly follow-up phone calls and during follow-up visit(s). Feedback from participants was recorded in the case report form and discussed with PI during weekly team meetings and/or immediately if participant had an urgent concern.
|
1.3%
1/75 • 1 month
Participants were asked about side effects/any changes in health during weekly follow-up phone calls and during follow-up visit(s). Feedback from participants was recorded in the case report form and discussed with PI during weekly team meetings and/or immediately if participant had an urgent concern.
|
|
Musculoskeletal and connective tissue disorders
Joint Pain
|
2.7%
2/75 • 1 month
Participants were asked about side effects/any changes in health during weekly follow-up phone calls and during follow-up visit(s). Feedback from participants was recorded in the case report form and discussed with PI during weekly team meetings and/or immediately if participant had an urgent concern.
|
1.3%
1/75 • 1 month
Participants were asked about side effects/any changes in health during weekly follow-up phone calls and during follow-up visit(s). Feedback from participants was recorded in the case report form and discussed with PI during weekly team meetings and/or immediately if participant had an urgent concern.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
1.3%
1/75 • 1 month
Participants were asked about side effects/any changes in health during weekly follow-up phone calls and during follow-up visit(s). Feedback from participants was recorded in the case report form and discussed with PI during weekly team meetings and/or immediately if participant had an urgent concern.
|
1.3%
1/75 • 1 month
Participants were asked about side effects/any changes in health during weekly follow-up phone calls and during follow-up visit(s). Feedback from participants was recorded in the case report form and discussed with PI during weekly team meetings and/or immediately if participant had an urgent concern.
|
|
Musculoskeletal and connective tissue disorders
Leg pain
|
0.00%
0/75 • 1 month
Participants were asked about side effects/any changes in health during weekly follow-up phone calls and during follow-up visit(s). Feedback from participants was recorded in the case report form and discussed with PI during weekly team meetings and/or immediately if participant had an urgent concern.
|
1.3%
1/75 • 1 month
Participants were asked about side effects/any changes in health during weekly follow-up phone calls and during follow-up visit(s). Feedback from participants was recorded in the case report form and discussed with PI during weekly team meetings and/or immediately if participant had an urgent concern.
|
|
Skin and subcutaneous tissue disorders
Discomfort at site of IV insertion
|
0.00%
0/75 • 1 month
Participants were asked about side effects/any changes in health during weekly follow-up phone calls and during follow-up visit(s). Feedback from participants was recorded in the case report form and discussed with PI during weekly team meetings and/or immediately if participant had an urgent concern.
|
1.3%
1/75 • 1 month
Participants were asked about side effects/any changes in health during weekly follow-up phone calls and during follow-up visit(s). Feedback from participants was recorded in the case report form and discussed with PI during weekly team meetings and/or immediately if participant had an urgent concern.
|
|
Endocrine disorders
Increases in blood sugar
|
2.7%
2/75 • 1 month
Participants were asked about side effects/any changes in health during weekly follow-up phone calls and during follow-up visit(s). Feedback from participants was recorded in the case report form and discussed with PI during weekly team meetings and/or immediately if participant had an urgent concern.
|
0.00%
0/75 • 1 month
Participants were asked about side effects/any changes in health during weekly follow-up phone calls and during follow-up visit(s). Feedback from participants was recorded in the case report form and discussed with PI during weekly team meetings and/or immediately if participant had an urgent concern.
|
|
General disorders
Hair loss
|
1.3%
1/75 • 1 month
Participants were asked about side effects/any changes in health during weekly follow-up phone calls and during follow-up visit(s). Feedback from participants was recorded in the case report form and discussed with PI during weekly team meetings and/or immediately if participant had an urgent concern.
|
0.00%
0/75 • 1 month
Participants were asked about side effects/any changes in health during weekly follow-up phone calls and during follow-up visit(s). Feedback from participants was recorded in the case report form and discussed with PI during weekly team meetings and/or immediately if participant had an urgent concern.
|
|
General disorders
Trouble sleeping/vivid dreams
|
1.3%
1/75 • 1 month
Participants were asked about side effects/any changes in health during weekly follow-up phone calls and during follow-up visit(s). Feedback from participants was recorded in the case report form and discussed with PI during weekly team meetings and/or immediately if participant had an urgent concern.
|
2.7%
2/75 • 1 month
Participants were asked about side effects/any changes in health during weekly follow-up phone calls and during follow-up visit(s). Feedback from participants was recorded in the case report form and discussed with PI during weekly team meetings and/or immediately if participant had an urgent concern.
|
|
General disorders
Brain fog
|
0.00%
0/75 • 1 month
Participants were asked about side effects/any changes in health during weekly follow-up phone calls and during follow-up visit(s). Feedback from participants was recorded in the case report form and discussed with PI during weekly team meetings and/or immediately if participant had an urgent concern.
|
2.7%
2/75 • 1 month
Participants were asked about side effects/any changes in health during weekly follow-up phone calls and during follow-up visit(s). Feedback from participants was recorded in the case report form and discussed with PI during weekly team meetings and/or immediately if participant had an urgent concern.
|
|
General disorders
Bilateral leg swelling
|
1.3%
1/75 • 1 month
Participants were asked about side effects/any changes in health during weekly follow-up phone calls and during follow-up visit(s). Feedback from participants was recorded in the case report form and discussed with PI during weekly team meetings and/or immediately if participant had an urgent concern.
|
0.00%
0/75 • 1 month
Participants were asked about side effects/any changes in health during weekly follow-up phone calls and during follow-up visit(s). Feedback from participants was recorded in the case report form and discussed with PI during weekly team meetings and/or immediately if participant had an urgent concern.
|
|
Immune system disorders
Swollen lymph node reported
|
0.00%
0/75 • 1 month
Participants were asked about side effects/any changes in health during weekly follow-up phone calls and during follow-up visit(s). Feedback from participants was recorded in the case report form and discussed with PI during weekly team meetings and/or immediately if participant had an urgent concern.
|
1.3%
1/75 • 1 month
Participants were asked about side effects/any changes in health during weekly follow-up phone calls and during follow-up visit(s). Feedback from participants was recorded in the case report form and discussed with PI during weekly team meetings and/or immediately if participant had an urgent concern.
|
|
General disorders
Hand swelling
|
1.3%
1/75 • 1 month
Participants were asked about side effects/any changes in health during weekly follow-up phone calls and during follow-up visit(s). Feedback from participants was recorded in the case report form and discussed with PI during weekly team meetings and/or immediately if participant had an urgent concern.
|
0.00%
0/75 • 1 month
Participants were asked about side effects/any changes in health during weekly follow-up phone calls and during follow-up visit(s). Feedback from participants was recorded in the case report form and discussed with PI during weekly team meetings and/or immediately if participant had an urgent concern.
|
|
Nervous system disorders
Tremors
|
1.3%
1/75 • 1 month
Participants were asked about side effects/any changes in health during weekly follow-up phone calls and during follow-up visit(s). Feedback from participants was recorded in the case report form and discussed with PI during weekly team meetings and/or immediately if participant had an urgent concern.
|
0.00%
0/75 • 1 month
Participants were asked about side effects/any changes in health during weekly follow-up phone calls and during follow-up visit(s). Feedback from participants was recorded in the case report form and discussed with PI during weekly team meetings and/or immediately if participant had an urgent concern.
|
|
Skin and subcutaneous tissue disorders
Hives or Welts
|
1.3%
1/75 • 1 month
Participants were asked about side effects/any changes in health during weekly follow-up phone calls and during follow-up visit(s). Feedback from participants was recorded in the case report form and discussed with PI during weekly team meetings and/or immediately if participant had an urgent concern.
|
2.7%
2/75 • 1 month
Participants were asked about side effects/any changes in health during weekly follow-up phone calls and during follow-up visit(s). Feedback from participants was recorded in the case report form and discussed with PI during weekly team meetings and/or immediately if participant had an urgent concern.
|
|
Infections and infestations
Sinus infection
|
0.00%
0/75 • 1 month
Participants were asked about side effects/any changes in health during weekly follow-up phone calls and during follow-up visit(s). Feedback from participants was recorded in the case report form and discussed with PI during weekly team meetings and/or immediately if participant had an urgent concern.
|
1.3%
1/75 • 1 month
Participants were asked about side effects/any changes in health during weekly follow-up phone calls and during follow-up visit(s). Feedback from participants was recorded in the case report form and discussed with PI during weekly team meetings and/or immediately if participant had an urgent concern.
|
|
Infections and infestations
Strep infection
|
0.00%
0/75 • 1 month
Participants were asked about side effects/any changes in health during weekly follow-up phone calls and during follow-up visit(s). Feedback from participants was recorded in the case report form and discussed with PI during weekly team meetings and/or immediately if participant had an urgent concern.
|
1.3%
1/75 • 1 month
Participants were asked about side effects/any changes in health during weekly follow-up phone calls and during follow-up visit(s). Feedback from participants was recorded in the case report form and discussed with PI during weekly team meetings and/or immediately if participant had an urgent concern.
|
|
Infections and infestations
Covid infection
|
2.7%
2/75 • 1 month
Participants were asked about side effects/any changes in health during weekly follow-up phone calls and during follow-up visit(s). Feedback from participants was recorded in the case report form and discussed with PI during weekly team meetings and/or immediately if participant had an urgent concern.
|
1.3%
1/75 • 1 month
Participants were asked about side effects/any changes in health during weekly follow-up phone calls and during follow-up visit(s). Feedback from participants was recorded in the case report form and discussed with PI during weekly team meetings and/or immediately if participant had an urgent concern.
|
|
Nervous system disorders
Migraine
|
0.00%
0/75 • 1 month
Participants were asked about side effects/any changes in health during weekly follow-up phone calls and during follow-up visit(s). Feedback from participants was recorded in the case report form and discussed with PI during weekly team meetings and/or immediately if participant had an urgent concern.
|
1.3%
1/75 • 1 month
Participants were asked about side effects/any changes in health during weekly follow-up phone calls and during follow-up visit(s). Feedback from participants was recorded in the case report form and discussed with PI during weekly team meetings and/or immediately if participant had an urgent concern.
|
|
Musculoskeletal and connective tissue disorders
ER visit due to work injury
|
1.3%
1/75 • 1 month
Participants were asked about side effects/any changes in health during weekly follow-up phone calls and during follow-up visit(s). Feedback from participants was recorded in the case report form and discussed with PI during weekly team meetings and/or immediately if participant had an urgent concern.
|
0.00%
0/75 • 1 month
Participants were asked about side effects/any changes in health during weekly follow-up phone calls and during follow-up visit(s). Feedback from participants was recorded in the case report form and discussed with PI during weekly team meetings and/or immediately if participant had an urgent concern.
|
|
Musculoskeletal and connective tissue disorders
ER visit/urgent care due to injury caused by fall
|
0.00%
0/75 • 1 month
Participants were asked about side effects/any changes in health during weekly follow-up phone calls and during follow-up visit(s). Feedback from participants was recorded in the case report form and discussed with PI during weekly team meetings and/or immediately if participant had an urgent concern.
|
2.7%
2/75 • 1 month
Participants were asked about side effects/any changes in health during weekly follow-up phone calls and during follow-up visit(s). Feedback from participants was recorded in the case report form and discussed with PI during weekly team meetings and/or immediately if participant had an urgent concern.
|
|
Psychiatric disorders
Relapse of existing depression
|
1.3%
1/75 • 1 month
Participants were asked about side effects/any changes in health during weekly follow-up phone calls and during follow-up visit(s). Feedback from participants was recorded in the case report form and discussed with PI during weekly team meetings and/or immediately if participant had an urgent concern.
|
1.3%
1/75 • 1 month
Participants were asked about side effects/any changes in health during weekly follow-up phone calls and during follow-up visit(s). Feedback from participants was recorded in the case report form and discussed with PI during weekly team meetings and/or immediately if participant had an urgent concern.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place