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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Provisional assignment of new diseases of uncertain etiology
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On 12 January 2020, a novel coronavirus was identified as the cause of an outbreak of unexplained pneumonia in Wuhan City, Hubei Province, China. This coronavirus was later named SARS-CoV-2, and the disease it causes COVID-19.
As of 15 March 2020, over 152,000 of COVID-19 have been diagnosed in 147 countries with a total of over 5,700 deaths; with 1,543 confirmed cases in the UK as of 16 March 2020.
Because of the lack of a serological test, the number, and so proportion, of people that develop asymptomatic infection remains unknown. This means that an accurate infection fatality estimate remains elusive.
Additionally, it is currently unknown why some patients develop severe COVID-19, while others have mild symptoms. Although general predisposing factors, such as hypertension, kidney disease and diabetes are well established, the exact mechanisms for these processes are not well characterised yet. We propose to use antibody detection
Antigen and antibody lateral flow assay (LFA) development has been led by Mologic as a quick diagnostic test for COVID-19. LFA and ELISA (enzyme-linked immunosorbent assay) have been developed for SARS-CoV-2 antigen detection in throat/ nose swabs and detection of antibodies in blood/serum (IgG, IgM) and saliva (IgG, IgM, IgA).
This study proposes to use these newly developed tests, for preliminary evaluation and subsequently on-site validation.
The use of the diagnostics developed here will improve management of cases of COVID-19, since these are designed to be non-expensive alternatives, easy to use and very rapid.
The rapid diagnosis of SARS-CoV-2 with antigen detection will allow patients to be rapidly triaged in hospital or in GP surgeries. They are sufficiently cheap that they will be appropriate for use in low/middle-income countries.
Additionally, antibody detection will allow both for diagnosis of immunity and infection before the manifestation of symptoms or even in asymptomatic cases.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
Type: Management of Care;Active Monitoring;
You can take part if:
You may not be able to take part if:
Workstream 1: - None Workstream 2: Cases (Positive SARS-CoV-2): - Aged less than 18 years - 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: ---metastatic malignancy ---congenital or acquired immunodeficiency; ---receipt of systemic corticosteroids (> = 20 mg/day of prednisone or equivalent) ---receipt of chronic systemic treatment with other known immunosuppressant medications, or radiotherapy Controls (Negative SARS-CoV-2): - Aged less than 18 years - Outpatients - History of known immune suppression: ---metastatic malignancy ---congenital or acquired immunodeficiency; ---receipt of systemic corticosteroids (³20 mg/day of prednisone or equivalent) ---receipt of chronic systemic treatment with other known immunosuppressant medications, or radiotherapy Workstream 3: - Aged less than 18 years - History of known immune suppression: ---metastatic malignancy ---congenital or acquired immunodeficiency; ---receipt of systemic corticosteroids (³20 mg/day of prednisone or equivalent) ---receipt of chronic systemic treatment with other known immunosuppressant medications, or radiotherapy
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
The study is sponsored by St. George's Hospital Medical School and funded by Wellcome Trust .
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Read full details
for Trial ID: CPMS 45485
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