Trial Outcomes & Findings for SARS-COV-2 Screening in Dialysis Facilities (NCT NCT05225298)

NCT ID: NCT05225298

Last Updated: 2024-10-30

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 2389 participants
• Primary outcome timeframe: 3 months
• Results posted on: 2024-10-30

Participant Flow

Patients were offered tests over a period of 3 months then entered a 1-month follow-up period.

Unit of analysis: Facilities

Participant milestones

Measure	Static Frequency Test based screening for SARS-CoV-2 every two weeks	Dynamic Frequency Test based screening for SARS-CoV-2 ranging from once a week to once every four weeks anchored to county COVID-19 case rates
Overall Study STARTED	1069 28	1320 29
Overall Study COMPLETED	1069 28	1320 29
Overall Study NOT COMPLETED	0 0	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

SARS-COV-2 Screening in Dialysis Facilities

Baseline characteristics by cohort

Measure	Static Frequency n=28 Facilities Test based screening for SARS-CoV-2 every two weeks	Dynamic Frequency n=29 Facilities Test based screening for SARS-CoV-2 ranging from once a week to once every four weeks anchored to county COVID-19 case rates	Total n=57 Facilities Total of all reporting groups
Age, Continuous	63 years n=5 Participants	65 years n=7 Participants	64 years n=5 Participants
Sex: Female, Male Female	478 Participants n=5 Participants	570 Participants n=7 Participants	1048 Participants n=5 Participants
Sex: Female, Male Male	591 Participants n=5 Participants	750 Participants n=7 Participants	1341 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	165 Participants n=5 Participants	173 Participants n=7 Participants	338 Participants n=5 Participants
Race/Ethnicity, Customized American Indian	72 Participants n=5 Participants	66 Participants n=7 Participants	138 Participants n=5 Participants
Race/Ethnicity, Customized Asian	26 Participants n=5 Participants	34 Participants n=7 Participants	60 Participants n=5 Participants
Race/Ethnicity, Customized Black	395 Participants n=5 Participants	490 Participants n=7 Participants	885 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Pacific Islander	26 Participants n=5 Participants	49 Participants n=7 Participants	75 Participants n=5 Participants
Race/Ethnicity, Customized White	381 Participants n=5 Participants	495 Participants n=7 Participants	876 Participants n=5 Participants
Race/Ethnicity, Customized Missing	4 Participants n=5 Participants	13 Participants n=7 Participants	17 Participants n=5 Participants
Region of Enrollment United States	1069 Participants n=5 Participants	1320 Participants n=7 Participants	2389 Participants n=5 Participants
Diabetes	720 Participants n=5 Participants	883 Participants n=7 Participants	1603 Participants n=5 Participants
Facility Region Northeast	4 Facilities n=60 Facilities	4 Facilities n=60 Facilities	8 Facilities n=120 Facilities
Facility Region Midwest	5 Facilities n=60 Facilities	5 Facilities n=60 Facilities	10 Facilities n=120 Facilities
Facility Region South	13 Facilities n=60 Facilities	14 Facilities n=60 Facilities	27 Facilities n=120 Facilities
Facility Region West	6 Facilities n=60 Facilities	6 Facilities n=60 Facilities	12 Facilities n=120 Facilities

PRIMARY outcome

Timeframe: 3 months

Population: All participants who started in the Participant Flow

Outcome measures

Measure	Static Frequency n=6347 Tests Test based screening for SARS-CoV-2 every two weeks	Dynamic Frequency n=6206 Tests Test based screening for SARS-CoV-2 ranging from once a week to once every four weeks anchored to county COVID-19 case rates
Number and Percentage of Total SARS-CoV-2 Tests Accepted Out of Total Tests Offered	509 Tests	475 Tests

SECONDARY outcome

Timeframe: 4 months

Outcome measures

Measure	Static Frequency n=1069 Participants Test based screening for SARS-CoV-2 every two weeks	Dynamic Frequency n=1320 Participants Test based screening for SARS-CoV-2 ranging from once a week to once every four weeks anchored to county COVID-19 case rates
Deaths	31 Participants	41 Participants

SECONDARY outcome

Timeframe: 4 months

Outcome measures

Measure	Static Frequency n=1069 Participants Test based screening for SARS-CoV-2 every two weeks	Dynamic Frequency n=1320 Participants Test based screening for SARS-CoV-2 ranging from once a week to once every four weeks anchored to county COVID-19 case rates
Hospitalizations	310 Participants	444 Participants

SECONDARY outcome

Timeframe: 4 months

Population: Data were not collected for this outcome measure

this survey is administered annually at each dialysis facility dialysis facility (based on Centers for Medicare Services regulation)

Outcome measures

Outcome data not reported

Adverse Events

Static Frequency

Serious events: 0 serious events

Other events: 0 other events

Deaths: 31 deaths

Dynamic Frequency

Serious events: 0 serious events

Other events: 0 other events

Deaths: 41 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Shuchi Anand, MD, MS

Stanford University

Phone: 650-725-2207

Email: sanand2@stanford.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place