NCT04453553

Brief Summary

The primary objective of the study is to determine whether, at 21 days, care homes that implemented near-patient daily testing have a lower rate of confirmed CoV-2 infections than care homes following the DHSC standard of care testing of symptomatic residents.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
461

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 29, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 1, 2020

Completed
1 day until next milestone

Study Start

First participant enrolled

July 2, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 27, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 27, 2020

Completed
Last Updated

August 2, 2023

Status Verified

July 1, 2023

Enrollment Period

4 months

First QC Date

June 29, 2020

Last Update Submit

July 31, 2023

Conditions

COVID

Keywords

COVID-19

Outcome Measures

Primary Outcomes (1)

  • CoV-2 Infection after 21 days

    The cumulative number of confirmed cases of CoV-2 infection after 21 days, measured by PCR detection of CoV-2, within the care home residents, staff and visitors

    21 days

Secondary Outcomes (3)

  • CoV-2 Infection after 14 days

    14 days

  • Cases of suspected or confirmed CoV-2 infection

    14 days

  • Hospitalisation and death

    21 days and 40 days

Study Arms (2)

Standard of care

ACTIVE COMPARATOR

Screening for COVID-19 via nasopharyngeal swab taken at day 0 and 14

Diagnostic Test: Nasopharyngeal swab and main laboratory

Near Patient Testing

EXPERIMENTAL

Screening for COVID-19 via nasopharyngeal swab taken at day 0 and 14, with the addition of daily nasal swabs tested via rapid test system

Diagnostic Test: Q16 testing

Interventions

Q16 testingDIAGNOSTIC_TEST

Nasal swab tested on a rapid near patient device

Near Patient Testing
Nasopharyngeal swab and main laboratoryDIAGNOSTIC_TEST

Standard of care testing

Standard of care

Eligibility Criteria

Age18 Years - 130 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Persons resident or requiring access to the care home
  • Capable of giving written informed consent, or if appropriate, having an acceptable individual capable of giving consent on the participant's behalf.

You may not qualify if:

  • Persons not providing informed consent or withdrawing consent at any time during the study.
  • Persons requiring urgent and immediate access to the care home, for example medical staff attending emergency visits.
  • Persons unable to provide nasal or oropharyngeal swabs for medical reasons.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Queen Mary University London

London, E1 2ES, United Kingdom

Location

Related Publications (15)

  • Public Health England. Outbreaks in Care Homes in England. Cumulative data to 17th May 2020

    BACKGROUND

  • University of Cambridge, MRC Biostatistics Unit. Nowcasting and Forecasting of COVID-19

    BACKGROUND

  • Comas-Herrera A and Zalakain J. Mortality associated with COVID-19 outbreaks in care homes: early international evidence. 12th April 2020

    BACKGROUND

  • McMichael TM, Currie DW, Clark S, Pogosjans S, Kay M, Schwartz NG, Lewis J, Baer A, Kawakami V, Lukoff MD, Ferro J, Brostrom-Smith C, Rea TD, Sayre MR, Riedo FX, Russell D, Hiatt B, Montgomery P, Rao AK, Chow EJ, Tobolowsky F, Hughes MJ, Bardossy AC, Oakley LP, Jacobs JR, Stone ND, Reddy SC, Jernigan JA, Honein MA, Clark TA, Duchin JS; Public Health-Seattle and King County, EvergreenHealth, and CDC COVID-19 Investigation Team. Epidemiology of Covid-19 in a Long-Term Care Facility in King County, Washington. N Engl J Med. 2020 May 21;382(21):2005-2011. doi: 10.1056/NEJMoa2005412. Epub 2020 Mar 27.

    PMID: 32220208BACKGROUND

  • Kimball A, Hatfield KM, Arons M, James A, Taylor J, Spicer K, Bardossy AC, Oakley LP, Tanwar S, Chisty Z, Bell JM, Methner M, Harney J, Jacobs JR, Carlson CM, McLaughlin HP, Stone N, Clark S, Brostrom-Smith C, Page LC, Kay M, Lewis J, Russell D, Hiatt B, Gant J, Duchin JS, Clark TA, Honein MA, Reddy SC, Jernigan JA; Public Health - Seattle & King County; CDC COVID-19 Investigation Team. Asymptomatic and Presymptomatic SARS-CoV-2 Infections in Residents of a Long-Term Care Skilled Nursing Facility - King County, Washington, March 2020. MMWR Morb Mortal Wkly Rep. 2020 Apr 3;69(13):377-381. doi: 10.15585/mmwr.mm6913e1.

    PMID: 32240128BACKGROUND

  • Roxby AC, Greninger AL, Hatfield KM, Lynch JB, Dellit TH, James A, Taylor J, Page LC, Kimball A, Arons M, Schieve LA, Munanga A, Stone N, Jernigan JA, Reddy SC, Lewis J, Cohen SA, Jerome KR, Duchin JS, Neme S. Detection of SARS-CoV-2 Among Residents and Staff Members of an Independent and Assisted Living Community for Older Adults - Seattle, Washington, 2020. MMWR Morb Mortal Wkly Rep. 2020 Apr 10;69(14):416-418. doi: 10.15585/mmwr.mm6914e2.

    PMID: 32271726BACKGROUND

  • World Health Organisation (WHO). Coronavirus disease 2019 (COVID-19) situation report 73. 2020

    BACKGROUND

  • Mizumoto K, Kagaya K, Zarebski A, Chowell G. Estimating the asymptomatic proportion of coronavirus disease 2019 (COVID-19) cases on board the Diamond Princess cruise ship, Yokohama, Japan, 2020. Euro Surveill. 2020 Mar;25(10):2000180. doi: 10.2807/1560-7917.ES.2020.25.10.2000180.

    PMID: 32183930BACKGROUND

  • Sheridan C. Fast, portable tests come online to curb coronavirus pandemic. Nat Biotechnol. 2020 May;38(5):515-518. doi: 10.1038/d41587-020-00010-2. No abstract available.

    PMID: 32203294BACKGROUND

  • Department of Health & Social Care. COVID-19: Our Action Plan for Adult Social Care. 15th April 2020

    BACKGROUND

  • He X, Lau EHY, Wu P, Deng X, Wang J, Hao X, Lau YC, Wong JY, Guan Y, Tan X, Mo X, Chen Y, Liao B, Chen W, Hu F, Zhang Q, Zhong M, Wu Y, Zhao L, Zhang F, Cowling BJ, Li F, Leung GM. Temporal dynamics in viral shedding and transmissibility of COVID-19. Nat Med. 2020 May;26(5):672-675. doi: 10.1038/s41591-020-0869-5. Epub 2020 Apr 15.

    PMID: 32296168BACKGROUND

  • Foundation for Innovative New Diagnostics. SARS-CoV-2 Molecular Assay Evaluation: Results

    BACKGROUND

  • Primerdesign™ Ltd. Primerdesign Ltd COVID-19 genesig® Real-Time PCR assay. Instructions for Use. Issue 1.01. 20th March 2020. Available at: https://www.fda.gov/media/136309/download (page 21)

    BACKGROUND

  • Ip DKM, Lau LLH, Chan KH, Fang VJ, Leung GM, Peiris MJS, Cowling BJ. The Dynamic Relationship Between Clinical Symptomatology and Viral Shedding in Naturally Acquired Seasonal and Pandemic Influenza Virus Infections. Clin Infect Dis. 2016 Feb 15;62(4):431-437. doi: 10.1093/cid/civ909. Epub 2015 Oct 30.

    PMID: 26518469BACKGROUND

  • NHS, PHE, DHSC and CQC. Admission and Care of Patients during COVID-19 Incident in a Care Home. 2nd April 2020. Version 1.

    BACKGROUND

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Joanne Martin

    Queen Mary University London

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
No masking will be used as the study arms have different testing patterns
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: randomised cluster trial of care homes
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 29, 2020

First Posted

July 1, 2020

Study Start

July 2, 2020

Primary Completion

October 27, 2020

Study Completion

October 27, 2020

Last Updated

August 2, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)