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NCT04351646
Diagnostics of COVID-19/DARTS (Development and Assessment of Rapid Testing for SARS-CoV-2 Outbreak)
trial in COVID-19 in 500 participants. Status unknown.
15 April 2022
Quick facts
| Lead sponsor | St George's, University of London |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 500 |
| Start date | 15 April 2020 |
| Primary completion | 15 April 2022 |
| Estimated completion | 15 April 2022 |
| Sites | 1 location across United Kingdom |
Conditions studied
- COVID-19 — all drugs for COVID-19 →
Sponsor
St George's, University of London
Who can join
18 and older, any sex, with COVID-19. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
7 peer-reviewed publications reference this trial (live from Europe PMC):
-
IgG Seroconversion and Pathophysiology in Severe Acute Respiratory Syndrome Coronavirus 2 Infection.
Staines HM, Kirwan DE, Clark DJ, Adams ER, et al · · 2021 · cited 34× · PMID 33256890 · DOI 10.3201/eid2701.203074 -
Increased monocyte distribution width in COVID-19 and sepsis arises from a complex interplay of altered monocyte cellular size and subset frequency.
Cusinato M, Hadcocks L, Yona S, Planche T, et al · · 2022 · cited 11× · PMID 35915915 · DOI 10.1111/ijlh.13941 -
Dynamics of IgG seroconversion and pathophysiology of COVID-19 infections
Staines HM, Kirwan DE, Clark DJ, Adams ER, et al · · 2020 · cited 9× · DOI 10.1101/2020.06.07.20124636 -
The QuantuMDx Q-POC SARS-CoV-2 RT-PCR assay for rapid detection of COVID-19 at point-of-care: preliminary evaluation of a novel technology.
Caffry J, Selby M, Barr K, Morgan G, et al · · 2023 · cited 7× · PMID 37330592 · DOI 10.1038/s41598-023-35479-9 -
SARS-CoV-2 enzyme-linked immunosorbent assays as proxies for plaque reduction neutralisation tests.
Kay GA, Owen SI, Giorgi E, Clark DJ, et al · · 2022 · cited 3× · PMID 35233014 · DOI 10.1038/s41598-022-07263-8 -
Reduced IFNL1 and/or IFNL2, but not IFNL3 is associated with worse outcome in patients with COVID-19.
Woods E, Mena A, Sierpinska S, Carr E, et al · · 2024 · cited 1× · PMID 38953458 · DOI 10.1093/cei/uxae047 -
The QuantuMDx Q-POC™ SARS-CoV-2 RT-PCR assay for rapid detection of COVID-19 at point-of-care: preliminary evaluation of a novel technology
Caffry J, Selby M, Barr K, Morgan G, et al · · 2021 · DOI 10.1101/2021.07.12.21260119
Verify or expand the search:
- PubMed search for NCT04351646
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other St George's, University of London trials
Trials by the same sponsor.
- NCT07012421 — Community Antibiotic Use, Susceptibility and ResisTance Among Patients With Urinary Tract Infections (CAST-UTI) · recruiting
- NCT06411405 — Using Machine Learning to Model Early-onset Neonatal Sepsis Risk in Uganda and Zimbabwe · unknown
- NCT05950984 — Medical Device (MD) Derived Pharmacokinetic (PK) Parameters for Vancomycin (MD-PK) · completed
- NCT05855889 — Observational Study of the Management of Infants With Congenital CMV · recruiting
- NCT06159218 — Eosinophilic Oesophagitis Assessment With String Testing · NA · unknown
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04351646 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by St George's, University of London
- Last refreshed: 17 April 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04351646.
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