Diagnostics of COVID-19/DARTS (Development and Assessment of Rapid Testing for SARS-CoV-2 Outbreak)

NCT04351646 | Unknown

• 1 other identifier: 2020.0075
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

This project will evaluate point-of-care / point-of-need (POC/PON) tests for the detection of the novel strain of coronavirus (2019 nCoV). We are working with Mologic Ltd, who have been funded by DFID/Wellcome Trust to develop a rapid, accurate and low cost, lateral flow assay (LFA) to detect viral circulating antigens and IgM/G against SARS-CoV-2 in less than 15 minutes. These POC/PON tests are intended for the rapid triage of patients with fever and/or cough and to identify patients likely to be immune from previous infections. In addition to this the POC/PON tests will be designed as self-tests, offering the additional benefit of enabling wide deployment in the home and community settings. In addition, we will evaluate ELISA assays, also produced by Mologic to detect IgG and IgM (and possibly IgA) against SARS-CoV-2. Comparison of antibody and antigen dynamics over time will compare with ELISA and quantitative RT-PCR.

Conditions

COVID-19

Keywords

SARS-CoV-2; COVID-19; coronavirus

Outcome Measures

Primary Outcomes (7)

• Antibody titres to SARS-CoV-2

  Antibody titres at day 3 post baseline samples.

  Day 3 post baseline samples

• Antibody titres to SARS-CoV-2

  Antibody titres at day 5 post baseline samples.

  Day 5 post baseline samples

• Antibody titres to SARS-CoV-2

  Antibody titres at day 7 post baseline samples.

  Day 7 post baseline samples

• Antibody titres to SARS-CoV-2

  Antibody titres at day 10 post baseline samples.

  Day 10 post baseline samples

• Antibody titres to SARS-CoV-2

  Antibody titres at day 14 post baseline samples.

  Days 14 post baseline samples

• Antibody titres to SARS-CoV-2

  Antibody titres at day 28 post baseline samples.

  Day 28 baseline samples

• Antibody titres to SARS-CoV-2

  Antibody titres at day 56 post baseline samples.

  Day 56 post baseline samples

Other Outcomes (4)

• Antigen dynamics

  Days 3, 5, 7,10 14 and 28 and 56 post baseline samples

• HLA-KIR interactions

  Days 3, 5, 7,10 14 and 28 and 56 post baseline samples

• Plasma cytokine levels

  Day 7, day 14 and optionally day 28.

Study Arms (3)

SARS-CoV-2 negative inpatients

Hospitalised adult patients with SARS-CoV-2 negative tests.

SARS-CoV-2 positive inpatients

Hospitalised adult patients with SARS-CoV-2 positive tests.

SARS-CoV-2 suspected or confirmed NHS staff

Suspected or proven SARS-CoV-2 positive cases amongst health care professionals and lab staff.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients population will include inpatients ad St George Hospital Foundation Trust (SGHFT) requiring SARS-CoV-2 test. Health Care Professionals population will encompass staff working at St George Hospital Foundation Trust (SGHFT) during the SARS-CoV-2 outbreak who are suspected or confirmed cases of SARS-CoV-2.

You may qualify if:

• Negative SARS-CoV-2:
• Aged 18 years of age or over
• Negative SARS-CoV-2 result from specimen received at SWLP laboratory in SGHFT
• Positive SARS-CoV-2:
• Aged 18 years of age or over
• Positive SARS-CoV-2 result from specimen received at SWLP laboratory in SGHFT
• Requires hospitalisation in SGHFT
• HCP with suspected or confirmed SARS-CoV-2:
• Aged 18 years of age
• Staff member with positive SARS-CoV-2 result from specimen received at SWLP laboratory in SGHFT or suspected diagnosis of COVID-19

You may not qualify if:

• Negative SARS-CoV-2:
• Aged less than 18 years
• Outpatients
• History of known immune suppression
• Positive SARS-CoV-2:
• Aged less than 18 years
• Patients unlikely to survive \>28 days in view of attending medical team
• Outpatients
• Anticipated transfer to another hospital within 72 hours
• History of known immune suppression
• HCP with suspected or confirmed SARS-CoV-2:
• Aged less than 18 years
• History of known immune suppression

Sponsors & Collaborators

• St George's, University of London: lead

Study Sites (1)

St. Georges Hospital Foundation Trust

London, SW17 0RE, United Kingdom

Location

Related Publications (1)

• Staines HM, Kirwan DE, Clark DJ, Adams ER, Augustin Y, Byrne RL, Cocozza M, Cubas-Atienzar AI, Cuevas LE, Cusinato M, Davies BMO, Davis M, Davis P, Duvoix A, Eckersley NM, Forton D, Fraser AJ, Garrod G, Hadcocks L, Hu Q, Johnson M, Kay GA, Klekotko K, Lewis Z, Macallan DC, Mensah-Kane J, Menzies S, Monahan I, Moore CM, Nebe-von-Caron G, Owen SI, Sainter C, Sall AA, Schouten J, Williams CT, Wilkins J, Woolston K, Fitchett JRA, Krishna S, Planche T. IgG Seroconversion and Pathophysiology in Severe Acute Respiratory Syndrome Coronavirus 2 Infection. Emerg Infect Dis. 2021 Jan;27(1):85-91. doi: 10.3201/eid2701.203074. Epub 2020 Nov 30.

  PMID: 33256890 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Nasopharyngeal swabs, saliva samples, blood samples

MeSH Terms

Conditions

COVID-19; Coronavirus Infections

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Timothy D Planche, Dr.

CONTACT

02087252683; tim.planche@nhs.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2020
• First Posted: April 17, 2020
• Study Start: April 15, 2020
• Primary Completion: April 15, 2022
• Study Completion: April 15, 2022
• Last Updated: April 17, 2020

Record last verified: 2020-04

Locations

GB (1)