Trial Outcomes & Findings for Stellate Ganglion Blockade in Corona Virus 2019 (COVID-19) Positive Patients (NCT NCT04445337)
NCT ID: NCT04445337
Last Updated: 2025-01-20
Results Overview
a) differences in mean/median values for SGB vs standard of care (SOC) will be assessed at each of the study designated time points for all the continuous biomarker measures - by assessing magnitude of difference and its 95% confidence level and testing differences for statistical significance at each of the time points;
TERMINATED
PHASE1
1 participants
3 month
2025-01-20
Participant Flow
Participant milestones
| Measure |
Open Label SGB
Initial perineural bolus injection - clonidine 100 mcg, Decadron sodium phosphate (PF) 5mg, and 0.25% bupivacaine 5 ml will be used for SGB block.
Stellate Ganglion Block: An injection of local anesthetic into the front of the neck. Medication used for the block include- clonidine 100 mcg, Decadron PF 5mg, and 0.25% bupivacaine 5 ml is delivered.
|
Control Arm
There will be no sham procedure for the control group. The control group will have nitric oxide levels performed once a day by a member of the research team. Lab draws will be drawn at the same frequency as the treatment group.
Control: Standard of care. Observation.
|
|---|---|---|
|
Overall Study
STARTED
|
0
|
1
|
|
Overall Study
COMPLETED
|
0
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Stellate Ganglion Blockade in Corona Virus 2019 (COVID-19) Positive Patients
Baseline characteristics by cohort
| Measure |
Stellate Ganglion Block
Initial perineural bolus injection - clonidine 100 mcg, Decadron PF 5mg, and 0.25% bupivacaine 5 ml will be used for SGB block.
Stellate Ganglion Block: An injection of local anesthetic into the front of the neck. Medication used for the block include- clonidine 100 mcg, Decadron PF 5mg, and 0.25% bupivacaine 5 ml is delivered.
|
Standard of Care
n=1 Participants
There will be no sham procedure for the control group. The control group will have nitric oxide levels performed once a day by a member of the research team. Lab draws will be drawn at the same frequency as the treatment group.
Control: Standard of care. Observation.
|
Total
n=1 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
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
—
|
50 years
n=7 Participants
|
50 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
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
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
—
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 monthPopulation: Differences in mean/median values for SGB vs standard of care (SOC) will be assessed at each of the study designated time points for all the continuous biomarker measures - by assessing the magnitude of difference and its 95% confidence level and testing differences for statistical significance at each of the time points; Unable to recruit sufficient subjects. Only one subject was randomized to the control group and did not receive the intervention.
a) differences in mean/median values for SGB vs standard of care (SOC) will be assessed at each of the study designated time points for all the continuous biomarker measures - by assessing magnitude of difference and its 95% confidence level and testing differences for statistical significance at each of the time points;
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 monthPopulation: Secondary outcome e) Differences between SGB vs SOC in frequency and time to occurrence of cardiac arrhythmias. Unable to recruit sufficient subjects. Only one subject was randomized to the control group and did not receive the intervention.
e) Differences between SGB vs SOC in frequency and time to occurrence of cardiac arrhythmias;
Outcome measures
Outcome data not reported
Adverse Events
Open Label SGB
Control Arm
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Michael Lankhorst
University of Nebraska Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place