Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12621001513808p
Ethics application status
Submitted, not yet approved
Date submitted
23/09/2021
Date registered
5/11/2021
Date last updated
5/11/2021
Date data sharing statement initially provided
5/11/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Free Jab (COVID-19) Control group in Australia
Health and risk outcomes for Australians who not intending to receive the COVID-19 vaccination.
Scientific title
Health outcomes for Australians who do not intend to receive the COVID-19 vaccination.
Secondary ID [1] 305396 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Not vaccinated against COVID-19 323753 0
Not planning to receive COVID-19 vaccinations 323821 0
Condition category
Condition code
Infection 321275 321275 0 0
Other infectious diseases
Respiratory 321328 321328 0 0
Other respiratory disorders / diseases
Inflammatory and Immune System 321329 321329 0 0
Normal development and function of the immune system

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This is an independent one-year term study
- Australians who are not vaccinated against COVID-19
- Monthly survey consultation (PARTICIPANT QUESTIONNAIRE (follow-ups)
1. Do you have any COVID-19 symptoms?
respiratory problems (cluster with cough)
sputum
shortness of breath
fever
muscle and joint pain
headaches
fatigue
Loss of smell or taste
2. Did you recently have the COVID-19 test?
negative
positive
3. Do you sick for last month?
yes (if yes what it was?)
no
4. Do you visit your GP or other specialists last month?
yes (if yes, what is the reason)
no
5. Do you get the COVID-19 vaccine last month?
No
Yes ( withdraw )

IF COVID-19 TESTS POSITIVE
Are you hospitalised (Yes. No)
Are you take any drugs (what kind?)
Are you taking any supplements (name and dose)
Would you like still to participate in this study (Yes No)
If No (reason-? COVID-19 Vaccine taken or other)
If vaccine Covid -19 is taken participants have to be withdrawn

IF THE PARTICIPANT HAS COVID-19 SYMPTOMS
(Send a letter with a recommendation to take COVID-19 test)

EXIT QUESTIONS
What is your reason to leave this study
Vaccination (COVID-19)
Join another study
Other (write your reason)

- Record any changes in the health of the participant
- No pharmaceutical drugs apply for this study
- Researcher will be administering or delivering these activities
Intervention code [1] 321805 0
Not applicable
Comparator / control treatment
NO control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 329106 0
For COVID19-related symptoms or problems
Online survey monthly, which will take about 5 minutes.
Timepoint [1] 329106 0
Time Frame: 52 weeks
Frequency of assessments: every 4 weeks for 52 weeks in total,
Primary outcome [2] 329108 0
Deaths among participants with newly diagnosed COVID19
Data will collect from an online survey (Monthly)
Timepoint [2] 329108 0
Time Frame: 52 weeks
Frequency of assessments: every 4 weeks for 52 weeks in total
Secondary outcome [1] 401303 0
COVID19-related hospital admissions/deaths in index cases at high risk of disease progression (defined as 70+ years;50-69 years; 30-49years; 18-29 years; 12-17years and 6months to 11years old with at least one comorbidity or risk factor.
Data will collect from an online survey (Monthly)
Timepoint [1] 401303 0
Time Frame: 52 weeks
Frequency of assessments: every 4 weeks for 52 weeks in total
Secondary outcome [2] 401304 0
COVID-19 infection in close household contacts
Data will collect from an online survey (Monthly)
Timepoint [2] 401304 0
Time frame- 52 weeks
Frequency of assessments: every 4 weeks for 52 weeks in total
Secondary outcome [3] 401305 0
Social outcomes: Education level of participants ( this data will be collected from personal details during the registration process) this data will be taken once.
Timepoint [3] 401305 0
Time frame - 52 weeks
Frequency of assessments: taken once on registration date.

Eligibility
Key inclusion criteria
Adults who don’t have yet received any of the COVID-19 vaccinations and are not planning to do this.
Parents/guardians who have been vaccinated against COVID-19 but want to add unvaccinated relatives can create a record to add them.
Ability and willingness to comprehend and consent in a timely manner.
Minimum age
6 Months
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Current hospitalization with COVID-19
Receipt of a COVID-19 vaccination
Unable to complete online questionnaires or follow study guidelines.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Volunteers Recruiting (1000+)
Descriptive statistics

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/12/2021
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
1000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 309758 0
Self funded/Unfunded
Name [1] 309758 0
Sylvia Smart
Country [1] 309758 0
Australia
Primary sponsor type
Individual
Name
Sylvia Smart
Address
Pure Nature Life - Natural Medicine Clinic
20 Sunny Waters Rd
Kincumber NSW 2251
Country
Australia
Secondary sponsor category [1] 310789 0
None
Name [1] 310789 0
Address [1] 310789 0
Country [1] 310789 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 309516 0
Bellberry Limited supporting research and ethics
Ethics committee address [1] 309516 0
Bellberry Limited supporting research and ethics

123 glen Osmond Road Eastwood SA 5063
Ethics committee country [1] 309516 0
Australia
Date submitted for ethics approval [1] 309516 0
01/11/2021
Approval date [1] 309516 0
Ethics approval number [1] 309516 0

Summary
Brief summary
This is a one-year independent study designed to provide a database for the unvaccinated population for comparative analysis with the vaccinated population in order to evaluate the success of the Covid19 mass vaccination programme and support future research projects. This study is not, and will never be, linked to any pharmaceutical company.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 114422 0
Mrs Sylvia Smart
Address 114422 0
Pure Nature Life- Natural Medicine Clinic
20 Sunny Waters Rd
KINCUMBER NSW 2251
Country 114422 0
Australia
Phone 114422 0
+61 478107777
Fax 114422 0
Email 114422 0
[email protected]
Contact person for public queries
Name 114423 0
Mrs Sylvia Smart
Address 114423 0
Pure Nature Life- Natural Medicine Clinic
20 Sunny Waters Rd
KINCUMBER NSW 2251
Country 114423 0
Australia
Phone 114423 0
+61 478107777
Fax 114423 0
Email 114423 0
[email protected]
Contact person for scientific queries
Name 114424 0
Mrs Sylvia Smart
Address 114424 0
Pure Nature Life- Natural Medicine Clinic
20 Sunny Waters Rd
KINCUMBER NSW 2251
Country 114424 0
Australia
Phone 114424 0
+61 478107777
Fax 114424 0
Email 114424 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
age, education, sex, outcomes
When will data be available (start and end dates)?
Beginning 3 months and ending 5 years following main results publication
Available to whom?
only researchers who provide a methodologically sound proposal
Available for what types of analyses?
only to achieve the aims in the approved proposal
How or where can data be obtained?
access subject to approvals by Principal Investigator (Sylvia Smart)
[email protected]
+61 478107777


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.