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ADAPT-C Sub-Study: Community-based cohort of people tested for COVID-19

ADAPT-C Sub-Study: Community-based cohort of people tested for COVID-19- negative control community-based cohorts of people tested for SARS-CoV-2, to enable evaluation of SARS-CoV-2 serological assays and long-term COVID-19 illness.

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12620000854932
Acronym
ADAPT-C
Enrollment
51
Registered
2020-08-27
Start date
2020-08-18
Completion date
2020-12-14
Last updated
2022-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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

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

St Vincent's Hospital, Sydney
Lead SponsorHospital

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026