Clinical Trials Logo

Clinical Trial Summary

The goal of this interventional study is to investigate whether continued use of regular asymptomatic testing in staff is a feasible, effective and cost-effective strategy to reduce the impact of COVID-19 in care homes. The trial aims to quantify the benefits and harms of regular asymptomatic testing in care home staff to inform policy. The rationale for regular asymptomatic testing is that it may reduce the risk of severe disease in residents and the frequency/severity of outbreaks. Participants (care home staff) will perform regular asymptomatic tests for Covid-19. Should they test positive they will be required to refrain from working and be provided with sick pay. Care providers will be reimbursed for the costs of employing agency staff to cover staff sickness absence that results directly from the trial.


Clinical Trial Description

To date the evidence based underpinning elements of the intervention has been developed through engagement work with the National Care Forum, senior managers of care homes and three stakeholder events with front-line care home staff. It will be finalised through a series of further workshops. These workshops will 1) consolidate existing insights into routine testing gleaned through past experiences in the COVID-19 pandemic; 2) discuss the intervention prototype; 3) operationalise it in ways which are likely to be acceptable and appropriate within the sector. The testing intervention will comprise of four modules that will be delivered in combination. Module 1: support payments for staff to enable them to self-isolate when unwell. Module 2: Branding and messaging around testing to promote engagement with testing. Module 3: Accessing training, protocols and planning. Module 4: Regular asymptomatic staff testing for COVID-19 using LFDs. Asymptomatic testing will be in addition to symptomatic testing for staff and residents, which is standard policy for all care homes in England. Providers will also receive funding to reimburse costs associated with employing agency staff to cover sickness absence for asymptomatic staff who test positive in the trial. Non-intervention care home residents and staff will be subject to the testing policy that is in place nationally at the time of the trial. Care home staff in control homes will not receive support payments (Module 1) and testing in control homes will not be supported by branding or messaging (Module 2). The degree to which training and testing protocols are already in place in control homes (Module 3) will be investigated in the stakeholder workshops. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05639205
Study type Interventional
Source University College, London
Contact Laura Shallcross, Professor
Phone 0203 549 5540
Email l.shallcross@ucl.ac.uk
Status Not yet recruiting
Phase Phase 3
Start date December 2022
Completion date April 2024

See also
  Status Clinical Trial Phase
Recruiting NCT06065033 - Exercise Interventions in Post-acute Sequelae of Covid-19 N/A
Completed NCT06267534 - Mindfulness-based Mobile Applications Program N/A
Completed NCT05047601 - A Study of a Potential Oral Treatment to Prevent COVID-19 in Adults Who Are Exposed to Household Member(s) With a Confirmed Symptomatic COVID-19 Infection Phase 2/Phase 3
Recruiting NCT05323760 - Functional Capacity in Patients Post Mild COVID-19 N/A
Recruiting NCT04481633 - Efficacy of Pre-exposure Treatment With Hydroxy-Chloroquine on the Risk and Severity of COVID-19 Infection N/A
Completed NCT04537949 - A Trial Investigating the Safety and Effects of One BNT162 Vaccine Against COVID-19 in Healthy Adults Phase 1/Phase 2
Completed NCT04612972 - Efficacy, Safety and Immunogenicity of Inactivated SARS-CoV-2 Vaccines (Vero Cell) to Prevent COVID-19 in Healthy Adult Population In Peru Healthy Adult Population In Peru Phase 3
Recruiting NCT05494424 - Cognitive Rehabilitation in Post-COVID-19 Condition N/A
Active, not recruiting NCT06039449 - A Study to Investigate the Prevention of COVID-19 withVYD222 in Adults With Immune Compromise and in Participants Aged 12 Years or Older Who Are at Risk of Exposure to SARS-CoV-2 Phase 3
Enrolling by invitation NCT05589376 - You and Me Healthy
Completed NCT05158816 - Extracorporal Membrane Oxygenation for Critically Ill Patients With COVID-19
Recruiting NCT04341506 - Non-contact ECG Sensor System for COVID19
Completed NCT04384445 - Zofin (Organicell Flow) for Patients With COVID-19 Phase 1/Phase 2
Completed NCT04512079 - FREEDOM COVID-19 Anticoagulation Strategy Phase 4
Active, not recruiting NCT05975060 - A Study to Evaluate the Safety and Immunogenicity of an (Omicron Subvariant) COVID-19 Vaccine Booster Dose in Previously Vaccinated Participants and Unvaccinated Participants. Phase 2/Phase 3
Active, not recruiting NCT05542862 - Spikogen Booster Study Phase 3
Terminated NCT05487040 - A Study to Measure the Amount of Study Medicine in Blood in Adult Participants With COVID-19 and Severe Kidney Disease Phase 1
Withdrawn NCT05621967 - Phonation Therapy to Improve Symptoms and Lung Physiology in Patients Referred for Pulmonary Rehabilitation N/A
Terminated NCT04498273 - COVID-19 Positive Outpatient Thrombosis Prevention in Adults Aged 40-80 Phase 3
Active, not recruiting NCT06033560 - The Effect of Non-invasive Respiratory Support on Outcome and Its Risks in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-COV-2)-Related Hypoxemic Respiratory Failure