Trial Outcomes & Findings for COVID-19 Serologic Strategies for Skilled Nursing Facilities (NCT NCT05270980)
NCT ID: NCT05270980
Last Updated: 2023-04-06
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
87 participants
Primary outcome timeframe
Up to Month 5
Results posted on
2023-04-06
Participant Flow
Participant milestones
| Measure |
Intervention Group (Cohorting) - Residents
Cohorting: The cohorting strategy will result in "pairing" serology-positive staff with serology-negative residents and serology-negative staff and serology-positive residents to the degree that penetration of serologic presumed immunity allows this pairing to be positive. This arm comprises residents of SNFs assigned to a cohorting strategy.
|
Control Group (No Cohorting) - Residents
Residents at SNFs where no cohorting has been assigned.
|
Intervention Group (Cohorting) - Staff
Staff at SNFs where the cohorting strategy has been assigned.
|
Control Group (No Cohorting) - Staff
Staff at control SNFs where no cohorting strategy has been assigned.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
14
|
2
|
50
|
21
|
|
Overall Study
COMPLETED
|
14
|
2
|
50
|
21
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
COVID-19 Serologic Strategies for Skilled Nursing Facilities
Baseline characteristics by cohort
| Measure |
Intervention Group (Cohorting) - Residents
n=14 Participants
Cohorting: The cohorting strategy will result in "pairing" serology-positive staff with serology-negative residents and serology-negative staff and serology-positive residents to the degree that penetration of serologic presumed immunity allows this pairing to be positive. This arm comprises residents of SNFs assigned to a cohorting strategy.
|
Control Group (No Cohorting) - Residents
n=2 Participants
Residents at SNFs where no cohorting strategy has been assigned.
|
Intervention Group (Cohorting) - Staff
n=50 Participants
Staff at SNFs where the cohorting strategy has been assigned.
|
Control Group (No Cohorting) - Staff
n=21 Participants
Staff at control SNFs where no cohorting strategy has been assigned.
|
Total
n=87 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
80 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Continuous
|
73 years
STANDARD_DEVIATION 13 • n=5 Participants
|
61 years
STANDARD_DEVIATION 30 • n=7 Participants
|
55 years
STANDARD_DEVIATION 10 • n=5 Participants
|
52 years
STANDARD_DEVIATION 8 • n=4 Participants
|
60.25 years
STANDARD_DEVIATION 15.25 • n=21 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
70 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
66 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=5 Participants
|
2 participants
n=7 Participants
|
50 participants
n=5 Participants
|
21 participants
n=4 Participants
|
87 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Up to Month 5Population: A HIPAA waiver was granted to obtain vaccination and PCR data from all residents in study units, not all of whom were participants. The overall number of participants analyzed for this outcome measure represent all residents of the SNFs for whom vaccination and PCR data were available. Therefore, the number of participants analyzed differs from the number of participants who completed the trial. Data were available for 207 residents in Intervention units and 207 residents in Control units.
Outcome measures
| Measure |
Intervention Group (Cohorting) - Residents
n=207 Participants
Cohorting: The cohorting strategy will result in "pairing" serology-positive staff with serology-negative residents and serology-negative staff and serology-positive residents to the degree that penetration of serologic presumed immunity allows this pairing to be positive. This arm comprises residents of SNFs assigned to a cohorting strategy.
|
Control Group (No Cohorting) - Residents
n=207 Participants
Residents of SNFs where no cohorting strategy was assigned.
|
|---|---|---|
|
Number of New COVID-19 Detected Infections Among Residents
|
0 Infections
|
0 Infections
|
SECONDARY outcome
Timeframe: Up to Month 5Population: A HIPAA waiver was granted to obtain vaccination and PCR data for all staff in study units, not all of whom were participants. The overall number of participants analyzed for this outcome measure represent all staff of the SNFs for whom vaccination and PCR data were available. Therefore, the number of participants analyzed differs from the number of participants who completed the trial. Data were available for 89 staff in Intervention units and 88 staff in Control units.
Outcome measures
| Measure |
Intervention Group (Cohorting) - Residents
n=89 Participants
Cohorting: The cohorting strategy will result in "pairing" serology-positive staff with serology-negative residents and serology-negative staff and serology-positive residents to the degree that penetration of serologic presumed immunity allows this pairing to be positive. This arm comprises residents of SNFs assigned to a cohorting strategy.
|
Control Group (No Cohorting) - Residents
n=88 Participants
Residents of SNFs where no cohorting strategy was assigned.
|
|---|---|---|
|
Number of New COVID-19 Detected Infections Among Staff
|
22 Infections
|
12 Infections
|
SECONDARY outcome
Timeframe: Up to Month 5Population: A HIPAA waiver was granted to obtain vaccination and PCR data for all residents in study units, not all of whom were participants. The overall number of participants analyzed for this outcome measure represent all residents of the SNFs for whom vaccination and PCR data were available. Therefore, the number of participants analyzed differs from the number of participants who completed the trial. Data were available for 207 residents in Intervention units and 207 residents in Control units.
Outcome measures
| Measure |
Intervention Group (Cohorting) - Residents
n=207 Participants
Cohorting: The cohorting strategy will result in "pairing" serology-positive staff with serology-negative residents and serology-negative staff and serology-positive residents to the degree that penetration of serologic presumed immunity allows this pairing to be positive. This arm comprises residents of SNFs assigned to a cohorting strategy.
|
Control Group (No Cohorting) - Residents
n=207 Participants
Residents of SNFs where no cohorting strategy was assigned.
|
|---|---|---|
|
Number of Hospitalizations Over Time
|
0 Hospitalizations
|
0 Hospitalizations
|
Adverse Events
Intervention Group (Cohorting) - Residents
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group (No Cohorting) - Residents
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Intervention Group (Cohorting) - Staff
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group (No Cohorting) - Staff
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