CICERO [COVID-19]
Research type
Research Study
Full title
CICERO - Covid-19 in vitro diagnostic near-patient testing in Care Environments using a Randomised Open-label trial design in an East London nursing home population
IRAS ID
285524
Contact name
Joanne Martin
Contact email
Sponsor organisation
Queen Mary University London
ISRCTN Number
ISRCTN12345678
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 3 months, 6 days
Research summary
Research Summary:
COVID-19 infection rates have been particularly high in care homes. Lots of work is going to try to reduce this. Key parts of reducing any spread of infection is to identify who is infected, and then to be able to separate them from others, and use protective equipment, so they dont spread it to others. The testing for the virus is typically done by taking a swab from the nose and throat, and then sending it to a laboratory for analysis. Current methods can take 24-48 hours to get a result back. The q16 equipment is a way of bringing the test equipment to the place you need it, and is faster than the routine testing, so that you can get the result back in 2 hours. We want to to the new pathway, so that we can show that the speed of the testing can help reduce the infection rate in the care homes, but getting the separation and protection methods in place faster.
Summary of Results:
240 participants(11 care homes) were randomised to intervention arm and 220 (11 care homes) to the control arm. 17 participants withdrew in the intervention arm and 7 in the control arm. Two patients died of unrelated causes , both in the intervention arm. There were no hospitaIisations for COVID.
In the intervention arm the number of those tested performed fell steadily over the 21 days of daily testing;133 (55.4%) were tested on day 7, 141 (58.8%) on day 14 and 118 (49.2%) on day 21.
In the control arm 159 (72.0%) were tested on day 7 and 153 (69.2%) on day 14. Testing was not offered on day 21.
One patient in the control arm tested positive on day 14. There were no positive tests in the intervention arm.
The trial was stopped when DHSC regulations changed, since care homes no longer had the same testing regimes, and were not prepared to implement additional trial testing.
REC name
West Midlands - Black Country Research Ethics Committee
REC reference
20/WM/0194
Date of REC Opinion
2 Jul 2020
REC opinion
Further Information Favourable Opinion