None listed
Conditions
Brief summary
There is pressing urgency to better understand the pathogenesis and physiologic consequences of COVID-19. The aim of the ADAPT study is to increase scientific knowledge regarding the immune and pathophysiologic consequences of COVID-19 infection. The aim of the ADAPT-C sub-study is to create SARS-CoV-2 negative control cohorts to the ADAPT study and enable development of serological assays to manage the disease burden of SARS-CoV-2.
Interventions
Participation will involve a maximum of 4 study visits to the Clinic over a 12 month period. 3x Negative Control Cohorts will be recruited Cohort C (n=50): COVID-19 negative, other coronavirus positive Cohort D (n=50-100): COVID-19 negative, respiratory viral panel negative, no known epidemiological risk factor for COVID-19 infection Cohort E (n=50): COVID-19 negative, respiratory viral panel negative, known epidemiological risk factor for COVID-19 infection (close contact of known COVID-19 case, overseas travel in 2 weeks prior to testing date) Participation will include Blood sampling 27mLs blood collected in SST and EDTA tubes (and an optional 36mLs in ACD tubes) will be taken at each time point in the study to create a biobank of samples suitable for COVID-19 related immunovirological research, and serological assay evaluation. Dried blood spot sampling A dried blood spot (DBS) will be collected at each time point (in comparison to phlebotomy sampling). DBS can be self-collected by participants at home if required. DBS will be mailed to participant with instructions on self-completion using standard educational materials developed for the use of DBS in HIV and HCV research. Health-Related Quality of Life (HRQoL) measures Study subjects will be asked to complete standardized HRQoL questionnaires at pre-specified follow-up timepoints. Survey instruments have been selected for general health measures, response to a major event and for psychological outcomes as follows: • Depression Scale • Impact of Events Scale • Somatic and Psychological Health Report (SPHERE) • EQ-5D Functional Impact of Illness
Sponsors
Eligibility
Inclusion criteria
18 years old and Over SARS-CoV-2 negative nasopharyngeal swab RVP test Cohort C: RVP positive for other non-SARS-CoV-2 coronavirus Cohort D: No documented respiratory pathogens on RVP and no known epidemiological link to COVID-19 case OR epidemiological risk factor including overseas travel or cruise ship Cohort E: No documented respiratory pathogens on RVP and a known epidemiological link to COVID-19 case OR epidemiological risk factor including overseas travel or cruise ship Able to provide informed consent
Exclusion criteria
Documented Positive SARS-CoV-2 test previously