COVID-19 Clinical Trial
Official title:
Development and Assessment of Rapid Testing for SARS-CoV-2 Outbreak (DARTS)
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.
Status | Not yet recruiting |
Enrollment | 500 |
Est. completion date | April 15, 2022 |
Est. primary completion date | April 15, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
==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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | St. Georges Hospital Foundation Trust | London |
Lead Sponsor | Collaborator |
---|---|
St George's, University of London |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Antigen dynamics | Viral (SARS-CoV-2) antigen dynamics over time | Days 3, 5, 7,10 14 and 28 and 56 post baseline samples | |
Other | HLA-KIR interactions | Examine HLA-KIR interactions in relation to CD8 anti-viral responses | Days 3, 5, 7,10 14 and 28 and 56 post baseline samples | |
Other | Plasma cytokine levels | 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 | Day 7, day 14 and optionally day 28. | |
Other | Transcriptome | 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. | Day 7, day 14 and optionally day 28. | |
Primary | Antibody titres to SARS-CoV-2 | Antibody titres at day 3 post baseline samples. | Day 3 post baseline samples | |
Primary | Antibody titres to SARS-CoV-2 | Antibody titres at day 5 post baseline samples. | Day 5 post baseline samples | |
Primary | Antibody titres to SARS-CoV-2 | Antibody titres at day 7 post baseline samples. | Day 7 post baseline samples | |
Primary | Antibody titres to SARS-CoV-2 | Antibody titres at day 10 post baseline samples. | Day 10 post baseline samples | |
Primary | Antibody titres to SARS-CoV-2 | Antibody titres at day 14 post baseline samples. | Days 14 post baseline samples | |
Primary | Antibody titres to SARS-CoV-2 | Antibody titres at day 28 post baseline samples. | Day 28 baseline samples | |
Primary | Antibody titres to SARS-CoV-2 | Antibody titres at day 56 post baseline samples. | Day 56 post baseline samples |
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