NCT05225298

SARS-COV-2 Screening in Dialysis Facilities

SARS-COV-2 Screening in Dialysis Facilities: Building an Optimal Strategy to Protect High Risk Populations

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,389 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Patients receiving dialysis are one of the highest risk groups for serious illness with SARS-CoV-2 infection. In addition to the inherent risks of travel to and dialysis within indoor facilities, patients receiving dialysis are more likely to be older, non-white, from disadvantaged backgrounds, and have impaired immune responses to viral infections and vaccinations. Universal testing offered at hemodialysis facilities could shield this vulnerable population from exposure, enable early identification and treatment for those affected, and reduce transmission to other patients and family members. In this pragmatic cluster randomized controlled trial as part of NIH RADx-UP Consortium, we will randomize 62 US Renal Care facilities with an estimated 2480 patients to static versus dynamic universal screening testing strategies. Static universal screening will involve offering patients SARS-CoV-2 screening tests every two weeks; the dynamic universal screening strategy will vary the frequency of testing from once every week to once every four weeks, depending on community COVID-19 case rates. We hypothesize that patients dialyzing at facilities randomized to a dynamic testing frequency responsive to community case rates will have higher test acceptability (primary outcome), experience lower rates of COVID-19 death and hospitalization, and report better experience-of-care metrics.

Conditions

• End-stage Renal Disease
• SARS-CoV-2 Acute Respiratory Disease
• Dialysis; Complications

Interventions

Type	Name	Description
BEHAVIORAL	Offering SARS-CoV-2 test	A pragmatic cluster (facility-level) randomized clinical trial, comparing test-based screening performed at a static (every two weeks) frequency versus a dynamic frequency (ranging from once a week to once every four weeks) anchored to county COVID-19 case rates

Timeline

• Start date: 2023-02-06
• Primary completion: 2023-08-01
• Completion: 2023-10-01
• First posted: 2022-02-04
• Last updated: 2024-10-30
• Results posted: 2024-10-30

Locations

1 site across 1 country: United States