Detection of SARS-CoV-2 RNA presence in colorectal mucus V1 [COVID-19]
Research type
Research Study
Full title
Detection of SARS-CoV-2 RNA presence in colorectal mucus collected from patients recovering from COVID-19 for assessing the risk of exposure to the virus in medical professionals performing invasive colorectal procedures including endoscopy.
IRAS ID
284824
Contact name
Alexandre Loktionov
Contact email
Sponsor organisation
DiagNodus Ltd
Clinicaltrials.gov Identifier
59632, Innovate UK - IFS (Innovation Funding Service)
Duration of Study in the UK
0 years, 5 months, 31 days
Research summary
The COVID-19 pandemic produces multiple challenges, being not only life-threatening for patients, but also elevating infection risk for medical personnel treating them. Although COVID-19 primarily targets the respiratory system, the gastrointestinal tract is usually involved as well. The virus is present in faeces, where it can persist when the symptoms disappear, and pharyngeal tests become negative. Moreover, the virus can be present in the faeces of asymptomatic individuals with prior exposure. COVID-19 faecal transmission is proven, but it is not known how quickly transmission risk recedes during recovery. One emerging problem is the risk of infecting medical personnel involved in frequent gastrointestinal procedures such as endoscopy and colorectal surgery. During the COVID-19 pandemic most of these procedures were suspended. There is an urgent need for reliable tests detecting COVID-19 presence in the human gut for assessing infection risk for medical professionals working in gastroenterology and colorectal surgery.\nAlthough the virus (COVID-19-causing SARS-CoV-2) was found in patients’ faeces, its highest concentrations should be present in the highly diagnostically informative colorectal mucus (CM) overlaying the internal surface of the large bowel.\nDiagNodus Ltd has developed a unique non-invasive technique for CM sampling (self-sampling). This technique combined with biomarker quantification was successfully applied for detecting inflammatory bowel disease and colorectal cancer. However, CM was not hitherto tried for determining the presence of infectious agents. This pilot study urgently undertaken by DiagNodus Ltd in collaboration with St George’s Hospital and St George’s University of London aims to provide a new diagnostic test for detecting SARS-CoV-2 RNA in CM samples from COVID-19 patients during recovery period, thus providing a tool for estimating exposure risk for medical professionals involved in gastrointestinal procedures. Successful completion of the project can provide a new diagnostic modality potentially expandable for assessing the presence of various infectious agents in CM.\n
REC name
London - Camberwell St Giles Research Ethics Committee
REC reference
20/HRA/3530
Date of REC Opinion
2 Sep 2020
REC opinion
Further Information Favourable Opinion