COVID19OptimiseNCT07337382
The Optimising Isolation, Quarantine and Distancing Study for COVID-19
An observational study of COVID19, run by Macfarlane Burnet Institute for Medical Research and Public Health Ltd at 2 sites in Australia.
Trial summary
The Australian government swift interventions and actions early to the COVID 19 epidemic included enforced quarantine, isolation, varying degrees of social and physical distancing measures, travel restrictions, community level testing and enhanced contact tracing models which effected the trajectory of the epidemic… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID19
- How many people
- 1,000 participants
- Where
- 2 sitesAustralia
- Study dates
- 30 Sep 2020to 30 Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants adults living in Victoria
Who may be able to join
- Community participants -
Who cannot join
- Unable to provide consent -
Trial locations and contacts
2 sites in 1 country.
Australia2 sites
The Macfarlane Burnet Institute for Medical Research and Public Health
Melbourne, Victoria, 3004
The Peter Doherty Institute for infection and immunity
Melbourne, Victoria, 3050
About this study
The Australian government swift interventions and actions early to the COVID 19 epidemic included enforced quarantine, isolation, varying degrees of social and physical distancing measures, travel restrictions, community level testing and enhanced contact tracing models which effected the trajectory of the epidemic impact. While the search for effective therapeutics and vaccines continues, it is important to understand how to effectively implement and optimise the current public health interventions available; application of traditional contact tracing , contributions of new contact tracing mobile phone applications, community level testing and use of specific fit for purpose diagnostic tests; to screen, detect and provide evidence of infection clearance. While the suppression measures have been effective on disease transmission rates, it has had economic, social and non COVID-19 health costs impacts. As community restrictions change it will be important to monitor and evaluate the effectiveness of these key interventions. This is a longitudinal study that will follow the experience and behaviors of 2 key risk populations impacted by COVID-19 transmission containment measures.
Read the detailed description
This is a mixed methods longitudinal study of a cohort of 1000 participants for a 12 month period. Victorian adults from three key risk populations will be recruited into two longitudinal cohort groups. It will follow the experiences and behaviors of the groups;
Recruitment group 1/Seed set 1 - recently diagnosed 'COVID-19 cases' (Group 1) and their social network with up to 2 waves of /Key people, will be followed up for 1 month initially with specific monitoring tools before they will transition into ongoing follow up and monitoring as recruitment group 2
Recruitment group 2/Seed set 2 - people from the general community that are not currently infected with COVID19 'Group 2' that are practicing physical distancing and represent specific key risk groups, and their social network with up to 2 waves of Key people.
Oversampling of vulnerable populations including people with disabilities, single parents and people living alone will be conducted across all groups.
Individuals may be invited to participate in more than one cohort when they change between risk population definitions.
The project aims to meet the following objectives using a longitudinal cohort design and a mixed method of qualitative and quantitative tools to enable us to assess changes within individuals over time and to assess the influence of social networks on their health, well-being, attitudes and perceptions. To assess the feasibility, acceptability and implementation of new interventions designed to support a reduction in disease transmission, including testing strategies, we will recruit a small sub-sample of participants into a sub-studies that will assess implementation outcomes.
Objectives of the study are:
- To assess adherence to government intervention strategies (i.e. early testing, isolation and physical distancing) and identify factors that promote/inhibit compliance to intervention strategies designed to reduce transmission.
- To better understand, assess and monitor the unintended health, social and economic consequences of the government interventions to control COVID-19 transmission
- To collect and collate empirical data regarding transmissions dynamics, social contacts and mixing patterns of COVID19 cases , their contacts and key vulnerable groups to develop and refine mathematical models that will improve the precision and timeliness of dynamic transmission estimates
- To test the acceptability, feasibility and effectiveness of (i) new and existing diagnostic tests and testing strategies and (ii) new and existing intervention strategies (therapeutic, behavioural, social) to support early diagnosis and subsequently reduce transmission.
- Conditions
- COVID19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Observational Group 1 | Group 1/Seed set 1 - recently diagnosed 'COVID-19 cases' (Group 1) and their social network with up to 2 waves of /Key people, will be followed up for 1 month initially with specific monitoring tools before they will transition into ongoing follow up and monitoring as recruitment group 2 | |
| Observational Group 2 | Group 2/Seed set 2 - people from the general community that are not currently infected with COVID19 'Group 2' that are practicing physical distancing and represent specific key risk groups, and their social network with up to 2 waves of Key people |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from response in baseline questionnaires to Adherence (non-adherence) with COVID19 transmission containment measures
Participants will complete behavioural questionnaires and diaries as binary daily measure of outcomes of compliance/non-adherence for each individual, determined by their ability to adhere to government regulations
Measured: 18 months
Change from response in baseline questionnaires depicting what are the unintended health, social and economic consequences of the government response to control COVID19 transmission
Participants will complete behavioural questionnaires and diaries. e.g. Anxiety (using GAD scale: https://patient.info/doctor/generalised-anxiety-disorder-assessment-gad-7).
Measured: 18 months
What are the social contacts and mixing patterns of COVID-19 cases
The behavioural questionnaire participants will be ask to complete include nominating the number of social network contacts per day.
Measured: 18 months
What are the types of social contacts and mixing patterns of COVID-19 cases
The questionnaire participants will be ask to complete will include nominating the relationship with their contacts per day(i.e. partner, child, friend), and individuals COVID test status, providing detailed specifics of the projects social network data.
Measured: 18 months
Measure of the efficacy of government interventions,
Participants responses to behavioural questionnaires and focus group discussions will be used as binary measurers; including but not limited to the number/proportion of participants who receive a score indicating accurate knowledge of government recommendations, receive a score of using COVID-19 prevention measures as recommended by the government.
Measured: 18 months
Secondary outcomes (3)
Collect data of positive COVID19 cases reported in study participant questionnaires.
The COVID 19 data will be analysed to determine the cases reported and if there are social contacts nominated in the questionnaires showing any linkage of cases. The social mixing patterns nominated of COVID19 cases, will be used to develop and refine mathematical models to improve precision and timeliness of dynamic transmission estimates.
Measured: 18 months
Assess the effectiveness of government interventions to reduce COVID-19 transmission from questionnaire responses from cohort participants
Including but not limited to the number/proportion of participants with accurate knowledge of government recommendations and the number/proportion of participants using COVID-19 prevention measures as recommended by the government.
Measured: 18 months
To investigate new and alternative tests to diagnose COVID-19.
Participants of the Optimise main study who are diagnosed with COVID-19 and their contacts will be invited to participate in a sub study of saliva testing compared with deep nasal/throat swab testing for the diagnosis of COVID-19 using RT-PCR
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2026
- Study start30 Sep 2020
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Other
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Macfarlane Burnet Institute for Medical Research and Public Health Ltd
- Sponsor type
- University, hospital or other
- Collaborators
- The Peter Doherty Institute for Infection and Immunity, University of Melbourne, Swinburne University of Technology, La Trobe University, Monash University, SNA Toolbox, Centre for Culture, Ethnicity & Health, Macquarie Group Foundation, Victorian State Government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07337382
- Sponsor's protocol ID
- 202006
- Acronym
- Optimise
- Status last verified
- Oct 2025
- First submitted
- 5 Nov 2020
- Last updated
- 13 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Optimising Isolation, Quarantine and Distancing Study for COVID-19
- ClinicalTrials.gov ID
- NCT07337382
- Acronym / sponsor ID
- Optimise / 202006
- Conditions
- COVID19
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Macfarlane Burnet Institute for Medical Research and Public Health LtdUniversity, hospital or other
- Collaborators
- The Peter Doherty Institute for Infection and Immunity, University of Melbourne, Swinburne University of Technology, La Trobe University, Monash University, SNA Toolbox, Centre for Culture, Ethnicity & Health, Macquarie Group Foundation, Victorian State Government
- Study start
- 30 Sep 2020 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 13 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Australian government swift interventions and actions early to the COVID 19 epidemic included enforced quarantine, isolation, varying degrees of social and physical distancing measures, travel restrictions, community level testing and enhanced contact tracing models which effected the trajectory of the epidemic impact. While the search for effective therapeutics and vaccines continues, it is important to understand how to effectively implement and optimise the current public health interventions available; application of traditional contact tracing , contributions of new contact tracing mobile phone applications, community level testing and use of specific fit for purpose diagnostic tests; to screen, detect and provide evidence of infection clearance. While the suppression measures have been effective on disease transmission rates, it has had economic, social and non COVID-19 health costs impacts. As community restrictions change it will be important to monitor and evaluate the effectiveness of these key interventions. This is a longitudinal study that will follow the experience and behaviors of 2 key risk populations impacted by COVID-19 transmission containment measures.
Detailed description
This is a mixed methods longitudinal study of a cohort of 1000 participants for a 12 month period. Victorian adults from three key risk populations will be recruited into two longitudinal cohort groups. It will follow the experiences and behaviors of the groups;
Recruitment group 1/Seed set 1 - recently diagnosed 'COVID-19 cases' (Group 1) and their social network with up to 2 waves of /Key people, will be followed up for 1 month initially with specific monitoring tools before they will transition into ongoing follow up and monitoring as recruitment group 2
Recruitment group 2/Seed set 2 - people from the general community that are not currently infected with COVID19 'Group 2' that are practicing physical distancing and represent specific key risk groups, and their social network with up to 2 waves of Key people.
Oversampling of vulnerable populations including people with disabilities, single parents and people living alone will be conducted across all groups.
Individuals may be invited to participate in more than one cohort when they change between risk population definitions.
The project aims to meet the following objectives using a longitudinal cohort design and a mixed method of qualitative and quantitative tools to enable us to assess changes within individuals over time and to assess the influence of social networks on their health, well-being, attitudes and perceptions. To assess the feasibility, acceptability and implementation of new interventions designed to support a reduction in disease transmission, including testing strategies, we will recruit a small sub-sample of participants into a sub-studies that will assess implementation outcomes.
Objectives of the study are:
- To assess adherence to government intervention strategies (i.e. early testing, isolation and physical distancing) and identify factors that promote/inhibit compliance to intervention strategies designed to reduce transmission.
- To better understand, assess and monitor the unintended health, social and economic consequences of the government interventions to control COVID-19 transmission
- To collect and collate empirical data regarding transmissions dynamics, social contacts and mixing patterns of COVID19 cases , their contacts and key vulnerable groups to develop and refine mathematical models that will improve the precision and timeliness of dynamic transmission estimates
- To test the acceptability, feasibility and effectiveness of (i) new and existing diagnostic tests and testing strategies and (ii) new and existing intervention strategies (therapeutic, behavioural, social) to support early diagnosis and subsequently reduce transmission.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Observational Group 1 | – | –Group 1/Seed set 1 - recently diagnosed 'COVID-19 cases' (Group 1) and their social network with up to 2 waves of /Key people, will be followed up for 1 month initially with specific monitoring tools before they will transition into ongoing follow up and monitoring as recruitment group 2 |
| Observational Group 2 | – | –Group 2/Seed set 2 - people from the general community that are not currently infected with COVID19 'Group 2' that are practicing physical distancing and represent specific key risk groups, and their social network with up to 2 waves of Key people |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants adults living in Victoria
Key inclusion criteria (1 listed)
- Community participants -
Key exclusion criteria (1 listed)
- Unable to provide consent -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change from response in baseline questionnaires to Adherence (non-adherence) with COVID19 transmission containment measures
Time frame: 18 months
Participants will complete behavioural questionnaires and diaries as binary daily measure of outcomes of compliance/non-adherence for each individual, determined by their ability to adhere to government regulations
Change from response in baseline questionnaires depicting what are the unintended health, social and economic consequences of the government response to control COVID19 transmission
Time frame: 18 months
Participants will complete behavioural questionnaires and diaries. e.g. Anxiety (using GAD scale: https://patient.info/doctor/generalised-anxiety-disorder-assessment-gad-7).
What are the social contacts and mixing patterns of COVID-19 cases
Time frame: 18 months
The behavioural questionnaire participants will be ask to complete include nominating the number of social network contacts per day.
What are the types of social contacts and mixing patterns of COVID-19 cases
Time frame: 18 months
The questionnaire participants will be ask to complete will include nominating the relationship with their contacts per day(i.e. partner, child, friend), and individuals COVID test status, providing detailed specifics of the projects social network data.
Measure of the efficacy of government interventions,
Time frame: 18 months
Participants responses to behavioural questionnaires and focus group discussions will be used as binary measurers; including but not limited to the number/proportion of participants who receive a score indicating accurate knowledge of government recommendations, receive a score of using COVID-19 prevention measures as recommended by the government.
3 secondary outcomes
Collect data of positive COVID19 cases reported in study participant questionnaires.
Time frame: 18 months
Assess the effectiveness of government interventions to reduce COVID-19 transmission from questionnaire responses from cohort participants
Time frame: 18 months
To investigate new and alternative tests to diagnose COVID-19.
Time frame: 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID19, run by Macfarlane Burnet Institute for Medical Research and Public Health Ltd at 2 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from response in baseline questionnaires to Adherence (non-adherence) with COVID19 transmission containment measures (time frame: 18 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2026.