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Trial registered on ANZCTR


Registration number
ACTRN12620000473965
Ethics application status
Approved
Date submitted
9/04/2020
Date registered
15/04/2020
Date last updated
10/09/2020
Date data sharing statement initially provided
15/04/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Reducing acute severe respiratory events in health care workers during the Covid-19 pandemic with OM85
Scientific title
Reducing acute severe respiratory events in health care workers during the Covid-19 pandemic with OM85
Secondary ID [1] 300976 0
BV-2020/19
Universal Trial Number (UTN)
U1111-1250-2920
Trial acronym
COVID RASP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Severe lower respiratory illness 317012 0
Covid-19 317014 0
Condition category
Condition code
Respiratory 315174 315174 0 0
Other respiratory disorders / diseases
Infection 315177 315177 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Study design: parallel group, wait list design, with treatment delayed by 3 months.
Open label OM85 one capsule (7.0mg) daily for 3 months with 3 months follow-up off treatment.
Adherence assessed by participant diary and blister pack return.
Intervention code [1] 317303 0
Prevention
Comparator / control treatment
wail list control (WLC) design with the WLC group starting active treatment with OM85 three months after the active treatment group.
Control group
Active

Outcomes
Primary outcome [1] 323437 0
Proportion of health care workers (HCW) contracting an acute respiratory illness necessitating workforce removal, assessed from workforce information including rosters and medical records.
Timepoint [1] 323437 0
Assessed at the end of month 3, prior to the wait-list control (WLC) commencing treatment.
Secondary outcome [1] 381943 0
Time to lower respiratory illness necessitating workforce removal, assessed from workforce information including rosters and medical records.
Timepoint [1] 381943 0
3 months post enrolment for the immediate treatment group and 6 months post enrolment for the wait-list control group
Secondary outcome [2] 381945 0
Proportion of health care workers contracting a lower respiratory inllness necessitating workforce removal, overall and by department, assessed from workforce information including rosters and medical records..
Timepoint [2] 381945 0
1). 3 months post enrolment for the immediate treatment group and 6 months post enrolment for the wait-list control group.
2). 6 months post enrolment for the immediate treatment group and 9 months post enrolment for the wait-list control group.
Secondary outcome [3] 381946 0
Total number of days with respiratory symptoms (upper or lower), assessed from participant daily diary.
Timepoint [3] 381946 0
1). 3 months post enrolment for the immediate treatment group and 6 months post enrolment for the wait-list control group.
2). 6 months post enrolment for the immediate treatment group and 9 months post enrolment for the wait-list control group
Secondary outcome [4] 381947 0
Proportion of health care workers with Covid-19 infection documented by PCR (nasal swab), seroconversion (blood sample) and/or Covid-19 positive lower respiratory illness necessitating workforce removal assessed from workforce information including rosters and medical records..
.
Timepoint [4] 381947 0
1). 3 months post enrolment for the immediate treatment group and 6 months post enrolment for the wait-list control group.
2). 6 months post enrolment for the immediate treatment group and 9 months post enrolment for the wait-list control group
Secondary outcome [5] 386799 0
Time to acute respiratory illness necessitating workforce removal, assessed from workforce information including rosters and medical records.
Timepoint [5] 386799 0
3 months post enrolment for the immediate treatment group and 6 months post enrolment for the wait-list control group

Eligibility
Key inclusion criteria
health care workers in the front line of assessing and caring for patients with suspected or proved Covid-19 infection
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
health care workers with previous Covid-19 infection necessitating workforce removal.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
open label study. No allocation concealment is required
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization by central randomization web service.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Wait list control, with the wait list group starting treatment after a 3 month delay
Phase
Phase 3
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Between-group differences in the primary outcome at 3 months will be assessed using log-binomial regression. Secondary outcomes measured to follow-up cessation will be assessed using mixed-effects models with group and stage (treatment/follow-up) (main effects and interaction) as fixed effects and HCW as random effect. Time-to-ARI and to LRI analyses will use the log-rank test.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 16411 0
Queensland Children's Hospital - South Brisbane
Recruitment hospital [2] 16413 0
The Prince Charles Hospital - Chermside
Recruitment hospital [3] 16414 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 29957 0
4032 - Chermside
Recruitment postcode(s) [2] 29955 0
4101 - South Brisbane
Recruitment postcode(s) [3] 29958 0
4102 - Woolloongabba

Funding & Sponsors
Funding source category [1] 305423 0
Government body
Name [1] 305423 0
Department of Health, MedicalResearch Future Fund,
Address [1] 305423 0
Department of Health
GPO Box 9848
Canberra ACT 2601
Australia
Country [1] 305423 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
Brisbane St Lucia, QLD 4072
Country
Australia
Secondary sponsor category [1] 305814 0
None
Name [1] 305814 0
Address [1] 305814 0
Country [1] 305814 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305744 0
The Children’s Health Queensland Human Research Ethics Committee
Ethics committee address [1] 305744 0
Human Research Ethics Committee
Centre for Children’s Health Research
Queensland Children’s Hospital Precinct
Level 7, 62 Graham Street
South Brisbane QLD 4101
Ethics committee country [1] 305744 0
Australia
Date submitted for ethics approval [1] 305744 0
30/04/2020
Approval date [1] 305744 0
13/05/2020
Ethics approval number [1] 305744 0
HREC/20/QCHQ/63520
Ethics committee name [2] 306874 0
The University of Queensland HUman Ethics Committee
Ethics committee address [2] 306874 0
Cumbrae-Stewart Building
The University of Queensland
St Lucia Qld 4072
Ethics committee country [2] 306874 0
Australia
Date submitted for ethics approval [2] 306874 0
13/05/2020
Approval date [2] 306874 0
13/05/2020
Ethics approval number [2] 306874 0
2020001397

Summary
Brief summary
The Covid-19 pandemic causes mild illness in most but when it spreads to the lungs it may cause a severe illness with acute respiratory distress syndrome (ARDS), severe systemic inflammation, respiratory failure and death in some. Front line Healthcare Workers (HCW) are at particularly high risk of contracting Covid-19 and sadly many HCW have died in the worst affected areas. Personal protective equipment such as masks are in short supply and surgical masks are unlikely to protect HCW from contracting the disease. Therefore we propose to treat healthy HCW with a drug which simultaneously targets front-line innate anti-viral immune defences, together with the core mechanism that controls immune response intensity in the airways.
Our hypothesis is that development of severe SARS-Cov-2 (COV)-associated ARDS in front-line health workers, even in those who have contracted this disease, can be prevented via a regimen of daily dosing with the bacterial-derived immunomodulatory agent OM85.
We propose a clinical trial to demonstrate reduction in acute respiratory illnesses in HCW necessitating workforce removal. 1000 HCW will be recruited in Brisbane and treated for 3 months using a wait-list study design. If successful, this trial will produce a treatment to protect doctors, nurses, and other frontline healthcare workers from developing the most serious form of the disease.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 101438 0
Prof Peter Sly
Address 101438 0
Centre for Children's Health Research
62 Graham St
South Brisbane Qld 4101
Country 101438 0
Australia
Phone 101438 0
+61 7 30697383
Fax 101438 0
Email 101438 0
p.sly@uq.edu.au
Contact person for public queries
Name 101439 0
Mrs Sharon Brabon
Address 101439 0
Centre for Children's Health Research
62 Graham St
South Brisbane Qld 4101
Country 101439 0
Australia
Phone 101439 0
+61 7 30697203
Fax 101439 0
Email 101439 0
s.brabon@uq.edu.au
Contact person for scientific queries
Name 101440 0
Prof Peter Sly
Address 101440 0
Centre for Children's Health Research
62 Graham St
South Brisbane Qld 4101
Country 101440 0
Australia
Phone 101440 0
+61 7 30697383
Fax 101440 0
Email 101440 0
p.sly@uq.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
immune profiles
When will data be available (start and end dates)?
2 years after final publication from the study, no end date determined.
Available to whom?
Researchers approved by study management committee
Available for what types of analyses?
Researchers will be able to undertake independent analyses of the associations between clinical outcomes and immune profiles using de-identified data only.
How or where can data be obtained?
Data can be obtained from the prinicpal investigator by email at p.sly@uq.edu.au.
What supporting documents are/will be available?
No other documents available
Summary results
No Results