CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 2,389 enrolled
Drug / intervention
Offering SARS-CoV-2 testbehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05225298
NCT05225298N/ACompleted

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

Stanford University·interventional·Posted Feb 4, 2022·Updated Oct 30, 2024

In Brief

A clinical study evaluating Offering SARS-CoV-2 test for End-stage Renal Disease and 2 related conditions. Completed, enrolled 2,389 participants across 1 site.

Detailed 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.

Study Details

Timeline

N/ACompletedFinished
20222023202420252026
First PostedFeb 4, 2022
Enrollment StartFeb 6, 2023
Primary CompletionAug 1, 2023
Study CompletionOct 1, 2023
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 4.4 years ago

Interventions

Offering SARS-CoV-2 testbehavioral

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