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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04496245




Registration number
NCT04496245
Ethics application status
Date submitted
26/07/2020
Date registered
3/08/2020
Date last updated
1/04/2021

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] 0 0
BV-2020/19
Universal Trial Number (UTN)
Trial acronym
COVIDRASP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Respiratory Viral Infection 0 0
Covid19 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Broncho-Vaxom®

Active Comparator: Wait-list control - One capsule OM85 (7.0 mg) will be given daily for 3 months, commencing in Month 3, with 3 months follow-up off treatment.

Experimental: Initial treatment wtih OM85 - One capsule OM85 (7.0 mg) will be given daily for 3 months, commencing on day 0, with 3 months follow-up off treatment.


Treatment: Drugs: Broncho-Vaxom®
Broncho-Vaxom adult capsules® (OM85)

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Acute Respiratory Infection necessitating workforce removal - The proportion of Health Care Workers contracting an Acute Respiratory Infection necessitating workforce removal in the initial treatment and wait-list control groups assessed at the end of 3 months.
Timepoint [1] 0 0
3 months
Secondary outcome [1] 0 0
Time to ARI necessitating workforce removal. - The time to the first ARI necessitating workforce removal in the initial treatment and wait-list control groups.
Timepoint [1] 0 0
12 months
Secondary outcome [2] 0 0
The proportion of Health Care Workers contracting an Acute Respiratory Infection necessitating workforce removal - The proportion of Health Care Workers contracting an Acute Respiratory Infection necessitating workforce removal in the initial treatment and wait-list control groups assessed at the end of 6 and 12 months
Timepoint [2] 0 0
12 months
Secondary outcome [3] 0 0
The proportion of HCW with documented Cov infection. - The proportion of HCW in the initial treatment and wait-list control group with Cov infection documented by molecular techniques of seroconversion
Timepoint [3] 0 0
12 months
Secondary outcome [4] 0 0
Time to Lower respiratory infection (LRI) necessitating workforce removal. - The time to the first LRI necessitating workforce removal in the initial treatment and wait-list control groups.
Timepoint [4] 0 0
12 months
Secondary outcome [5] 0 0
The proportion of Health Care Workers contracting a LRI necessitating workforce removal - The proportion of Health Care Workers contracting LRI necessitating workforce removal in the initial treatment and wait-list control groups assessed at the end of 3, 6 and 12 months
Timepoint [5] 0 0
12 months
Secondary outcome [6] 0 0
The proportion of HCW with documented Cov LRI. - The proportion of HCW in the initial treatment and wait-list control group with LRI due to Cov infection documented by molecular techniques of seroconversion
Timepoint [6] 0 0
12 months

Eligibility
Key inclusion criteria
Participants who meet all of the following criteria are eligible for enrolment:

1. HCW in front line clinical departments assessing or caring for patients with suspected
or verified COV infection in one of the recruiting hospitals in Brisbane

2. Participants who, in the opinion of the investigator, are able to comply with the
protocol for its duration,

3. Written informed consent signed and dated according to local regulations.
Minimum age
18 Years
Maximum age
100 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants who meet any of these criteria are not eligible for enrolment:

- Staff with prior COV 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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
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] 0 0
The Prince Charles Hospital - Brisbane
Recruitment hospital [2] 0 0
The Princess Alexandra Hospital - Brisbane
Recruitment hospital [3] 0 0
Queensland Children's Hospital - South Brisbane
Recruitment postcode(s) [1] 0 0
4032 - Brisbane
Recruitment postcode(s) [2] 0 0
4102 - Brisbane
Recruitment postcode(s) [3] 0 0
4101 - South Brisbane

Funding & Sponsors
Primary sponsor type
Other
Name
The University of Queensland
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Griffith University
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
The Prince Charles Hospital
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Princess Alexandra Hospital, Brisbane, Australia
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Telethon Kids Institute
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
Queensland Children's Hospital, Brisbane, Australia
Address [5] 0 0
Country [5] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Parallel group, Wait-list design, with treatment delayed for 3 months. Participants will be
randomized on a 1:1 ratio with 500 participants per group in Australia.

Group 1: Wait-list control. One capsule OM85 (7.0 mg) will be given daily for 3 months,
commencing in Month 3, with 3 months follow-up off treatment.

Group 2: Initial treatment. One capsule OM85 (7.0 mg) will be given daily for 3 months,
commencing on day 0, with 3 months follow-up off treatment.
Trial website
https://clinicaltrials.gov/show/NCT04496245
Trial related presentations / publications
Sly PD, Galbraith S, Islam Z, Holt B, Troy N, Holt PG. Primary prevention of severe lower respiratory illnesses in at-risk infants using the immunomodulator OM-85. J Allergy Clin Immunol. 2019 Sep;144(3):870-872.e11. doi: 10.1016/j.jaci.2019.05.032. Epub 2019 Jun 8.
Esposito S, Soto-Martinez ME, Feleszko W, Jones MH, Shen KL, Schaad UB. Nonspecific immunomodulators for recurrent respiratory tract infections, wheezing and asthma in children: a systematic review of mechanistic and clinical evidence. Curr Opin Allergy Clin Immunol. 2018 Jun;18(3):198-209. doi: 10.1097/ACI.0000000000000433.
The Lancet. COVID-19: protecting health-care workers. Lancet. 2020 Mar 21;395(10228):922. doi: 10.1016/S0140-6736(20)30644-9.
Public notes

Contacts
Principal investigator
Name 0 0
PETER D SLY, DSc
Address 0 0
The University of Queensland
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications