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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04351646
Recruitment Status : Not yet recruiting
First Posted : April 17, 2020
Last Update Posted : April 17, 2020
Sponsor:
Information provided by (Responsible Party):
St George's, University of London

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.


Condition or disease
COVID-19

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Development and Assessment of Rapid Testing for SARS-CoV-2 Outbreak (DARTS)
Estimated Study Start Date : April 15, 2020
Estimated Primary Completion Date : April 15, 2022
Estimated Study Completion Date : April 15, 2022

Group/Cohort
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.



Primary Outcome Measures :
  1. Antibody titres to SARS-CoV-2 [ Time Frame: Day 3 post baseline samples ]
    Antibody titres at day 3 post baseline samples.

  2. Antibody titres to SARS-CoV-2 [ Time Frame: Day 5 post baseline samples ]
    Antibody titres at day 5 post baseline samples.

  3. Antibody titres to SARS-CoV-2 [ Time Frame: Day 7 post baseline samples ]
    Antibody titres at day 7 post baseline samples.

  4. Antibody titres to SARS-CoV-2 [ Time Frame: Day 10 post baseline samples ]
    Antibody titres at day 10 post baseline samples.

  5. Antibody titres to SARS-CoV-2 [ Time Frame: Days 14 post baseline samples ]
    Antibody titres at day 14 post baseline samples.

  6. Antibody titres to SARS-CoV-2 [ Time Frame: Day 28 baseline samples ]
    Antibody titres at day 28 post baseline samples.

  7. Antibody titres to SARS-CoV-2 [ Time Frame: Day 56 post baseline samples ]
    Antibody titres at day 56 post baseline samples.


Other Outcome Measures:
  1. Antigen dynamics [ Time Frame: Days 3, 5, 7,10 14 and 28 and 56 post baseline samples ]
    Viral (SARS-CoV-2) antigen dynamics over time

  2. HLA-KIR interactions [ Time Frame: Days 3, 5, 7,10 14 and 28 and 56 post baseline samples ]
    Examine HLA-KIR interactions in relation to CD8 anti-viral responses

  3. Plasma cytokine levels [ Time Frame: Day 7, day 14 and optionally day 28. ]
    Plasma levels of cytokines (e.g. IL-1, IL-6, TNF-alpha, TGF-beta) measured by Luminex multiplex and/or ELISA assays and expressed in ug/ml

  4. Transcriptome [ Time Frame: Day 7, day 14 and optionally day 28. ]
    Total RNA will be isolated then used for cDNA synthesis and amplification. Samples will undergo 100-bp DNA sequencing, sequenced reads will be aligned to a reference genome and differentially expressed genes analysed using open source software. Pathway enrichment analysis will then be performed and the Mixture of Isoforms probabilistic framework applied to assess alternative transcription events. Differential gene expression analysis will identify key genes upregulated in COVID-19 versus control subjects, and at different timepoints in the COVID-19 disease process.


Biospecimen Retention:   Samples With DNA
Nasopharyngeal swabs, saliva samples, blood samples


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Criteria

==INCLUSION CRITERIA =========

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

==EXCLUSION CRITERIA =========

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04351646


Contacts
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Contact: Timothy D Planche, Dr. 02087252683 tim.planche@nhs.net

Locations
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United Kingdom
St. Georges Hospital Foundation Trust
London, United Kingdom, SW17 0RE
Contact: Timothy D Planche, Dr.    02087252683    tim.planche@nhs.net   
Sponsors and Collaborators
St George's, University of London
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Responsible Party: St George's, University of London
ClinicalTrials.gov Identifier: NCT04351646    
Other Study ID Numbers: 2020.0075
First Posted: April 17, 2020    Key Record Dates
Last Update Posted: April 17, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by St George's, University of London:
SARS-CoV-2
COVID-19
coronavirus