ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12620000854932

Ethics application status

Approved

Date submitted

13/08/2020

Date registered

27/08/2020

Date last updated

16/02/2022

Date data sharing statement initially provided

27/08/2020

Type of registration

Retrospectively registered

Titles & IDs

Public title

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

Scientific title

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.

Secondary ID [1]

Universal Trial Number (UTN)

Trial acronym

ADAPT-C

Linked study record

This study is a a sub-study of the ACTRN12620000554965 study. This study is establishing a negative control group

Health condition

Health condition(s) or problem(s) studied:

COVID 19

Condition category

Condition code

Infection

Other infectious diseases

Respiratory

Other respiratory disorders / diseases

Intervention/exposure

Study type

Observational

Patient registry

False

Target follow-up duration

Target follow-up type

Description of intervention(s) / exposure

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

Intervention code [1]

Early Detection / Screening

Comparator / control treatment

The 3 negative control Cohorts recruited for this study will establish the control groups for the Main study-ADAPT Study (ACTRN12620000554965). This study is establishing a negative control group.

Control group

Active

Outcomes

Primary outcome [1]

The biobank collection of blood samples and serological assays from SARS-CoV-2 negative population

Timepoint [1]