Solutions for your COVID-19 Clinical Trials
Sonic Clinical Trials (SCT) is committed and well-positioned in working with healthcare professionals, researchers and the bio-pharmaceutical industry to support the conduct of clinical trials for COVID-19 vaccines and therapeutics.
Developing a vaccine or therapeutic in response to the outbreak of the 2019 Novel Coronavirus (COVID-19) requires a trusted laboratory partner with significant technical and medical expertise.
Prior to the current pandemic commercial assays testing for the presence of the novel coronavirus SARS-CoV-2 had not been developed. Several manufacturers have recently released assays for the detection of SARS-CoV-2 RNA based upon real-time reverse transcriptase (RT) polymerase chain reaction (PCR) technology. While assays have yet to complete full verification studies some have gained FDA approval for emergency use under the conditions of the current pandemic.
SCT’s co-located clinical laboratory, Douglass Hanly Moir Pathology (DHM) has established real-time PCR based assays for SARS-CoV-2 RNA from two manufacturers. Both assays have FDA approval for emergency use. These assays are real-time RT-PCR methods intended for the qualitative detection of RNA from SARS-CoV-2 in nasopharyngeal and oropharyngeal swab specimens from patients who meet COVID-19 current clinical and/or epidemiological criteria.
SARS-CoV-2 RNA testing at DHM is now available for use by SCT.
Reagent manufacturers are rapidly developing assays for SARS-CoV-2 antibodies (IgG and IgM). These include both point of care tests (POCT) as well as higher volume laboratory based assays. SCT and DHM are currently evaluating both POCT and laboratory based SARS-CoV-2 serology assays and patient testing will become available in the near future.
In the meantime SCT has the capacity to store samples for later testing.
Supplementary testing for patients infected with SARS-CoV-2
In addition to SARS-CoV-2 RNA and serology testing many other routine pathology tests and specific biomarkers are essential to assess disease severity and prognosis in affected patients.
In addition to routine pathology tests including renal and liver function tests and full blood count (FBC) a number of inflammatory markers and other biomarkers have become essential in the management of COVID-19 patients.
Inflammatory markers identified as useful include erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), procalcitonin (PCT), ferritin and interleukin-6 (IL-6). IL-6 in particular correlates with severity of lung disease and prognosis.
Other important biomarkers include troponins for detection of myocardial injury.
All of the above tests are currently available in SCT or DHM laboratories.
Self-collection of swabs
Sonic has conducted validation studies which support the accuracy of self-collected throat and nasal specimens. This is a convenient way to collect and helps limit the spread of the virus to clinic staff, investigators and other patients, while preserving PPE.