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Reducing Acute Severe Respiratory Events in Health Care Workers During the Covid-19 Pandemic With OM85 (COVIDRASP)

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ClinicalTrials.gov Identifier: NCT04496245
Recruitment Status : Recruiting
First Posted : August 3, 2020
Last Update Posted : September 4, 2020
Sponsor:
Collaborators:
Griffith University
The Prince Charles Hospital
Princess Alexandra Hospital, Brisbane, Australia
Telethon Kids Institute
Queensland Children's Hospital, Brisbane, Australia
Information provided by (Responsible Party):
The University of Queensland

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.


Condition or disease Intervention/treatment Phase
Respiratory Viral Infection Covid19 Drug: Broncho-Vaxom® Phase 3

Detailed Description:

The Covid-19 pandemic has been characterised by acute respiratory distress syndrome (ARDS) accompanied by a systemic cytokine-storm resulting in severe illness, respiratory failure and death in some. Severe Acute Respiratory Syndrome (SARS)- Coronavirus (Cov-2) (COV) infection per se is not the only underlying issue here, as it is becoming evident that ARDS is relatively rare amongst infected subjects, and appears to be associated with gross dysregulation of ensuing host-anti-viral responses resulting in collateral immune-inflammatory-mediated damage to host tissues. Rather than waiting for susceptible subjects to present with COV-associated ARDS, the investigators propose treatment of healthy health care workers (HCW) with a therapeutic agent which simultaneously targets front-line innate anti-viral immune defences, together with the core mechanism that controls immune response intensity in the airways. This research addresses the hypothesis that resistance to development of severe COV-associated respiratory disease in front-line HCW, even in those who develop a primary infection, can be boosted via a regimen of daily dosing with the bacterial-derived immunomodulatory agent OM85.

Aims

  1. To demonstrate that daily treatment with OM85 will prevent HCW developing acute respiratory infections (ARI) necessitating removal from the workforce.
  2. To elucidate the mechanism of action by which OM85 regulates host immune responses against COV.

Mechanistic studies will primarily test the hypothesis that OM85 pre-treatment modulates the systemic immunoinflammatory response to COV, selectively attenuating potentially pathogenic pro-inflammatory pathways without compromising activation of innate immune pathways central to pathogen clearance. The investigators will additionally collect samples to test the secondary hypothesis that the host response to COV displays uniquely aggressive pro-inflammatory features that differ from those observed with non-COV respiratory infections.

Experimental design: participants will be randomised into two groups; Immediate treatment with OM85 (n=500) or wait-list control with OM85 commencing three months later (n=500). Venous blood samples will be collected from each subject at four time points. Sera will be stored from each time point for assay of COV-specific antibody. For the mechanistic studies the investigators will focus on two groups of subjects who test respectively positive or negative to COV during a defined respiratory illness. These will be further stratified by treatment (OM85 treated (OM+) versus non-treated (OM-) prior to ARI, yielding 4 sets (each n=50) of test samples collected at acute infection which will be utilized for two discrete cross-comparisons: (i) COV+/OM+ versus COV+/OM-, and (ii) COV-/OM+ versus COV-/OM-. Analyses in (i) will be prioritised as they relate exclusively to host-responses to COV and effects of treatment thereon; those in (ii) which will contrast COV-associated response with those elicited by conventional respiratory pathogens and compare respective susceptibility to OM85.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will be randomized to either Group 1 (waitlist control, delayed treatment group) or Group 2 (initial treatment) for treatment for a period of 3 months with 3 months follow-up off treatment
Masking: None (Open Label)
Masking Description: Participants will be randomised to the wait list group (Group 1) or the initial intervention group (Group 2) using a one-to-one ratio, stratified by hospital and department [High risk, lower risk].
Primary Purpose: Prevention
Official Title: Reducing Acute Severe Respiratory Events in Health Care Workers During the Covid-19 Pandemic With OM85
Actual Study Start Date : August 24, 2020
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Drug: Broncho-Vaxom®
Broncho-Vaxom adult capsules® (OM85)
Other Name: OM85

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.
Drug: Broncho-Vaxom®
Broncho-Vaxom adult capsules® (OM85)
Other Name: OM85




Primary Outcome Measures :
  1. Acute Respiratory Infection necessitating workforce removal [ Time Frame: 3 months ]
    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.


Secondary Outcome Measures :
  1. Time to ARI necessitating workforce removal. [ Time Frame: 12 months ]
    The time to the first ARI necessitating workforce removal in the initial treatment and wait-list control groups.

  2. The proportion of Health Care Workers contracting an Acute Respiratory Infection necessitating workforce removal [ Time Frame: 12 months ]
    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

  3. The proportion of HCW with documented Cov infection. [ Time Frame: 12 months ]
    The proportion of HCW in the initial treatment and wait-list control group with Cov infection documented by molecular techniques of seroconversion

  4. Time to Lower respiratory infection (LRI) necessitating workforce removal. [ Time Frame: 12 months ]
    The time to the first LRI necessitating workforce removal in the initial treatment and wait-list control groups.

  5. The proportion of Health Care Workers contracting a LRI necessitating workforce removal [ Time Frame: 12 months ]
    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

  6. The proportion of HCW with documented Cov LRI. [ Time Frame: 12 months ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Exclusion Criteria:

Participants who meet any of these criteria are not eligible for enrolment:

  • Staff with prior COV infection necessitating workforce removal

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04496245


Contacts
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Contact: PETER D SLY, Dsc +61730697383 p.sly@uq.edu.au
Contact: SHARON L BRABON, PGCM +61730697203 s.brabon@uq.edu.au

Locations
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Australia, Queensland
The Prince Charles Hospital Not yet recruiting
Brisbane, Queensland, Australia, 4032
Contact: David Reid, MB MD    +6173139 4000    david.reid@health.qld.gov.au   
The Princess Alexandra Hospital Recruiting
Brisbane, Queensland, Australia, 4102
Contact: John Upham, MBBS PhD    +6173443 8065    j.upham@uq.edu.au   
Queensland Children's Hospital Recruiting
South Brisbane, Queensland, Australia, 4101
Contact: Adam Irwin, MBBS PhD    +617 3068 1111    a.irwin@uq.edu.au   
Sponsors and Collaborators
The University of Queensland
Griffith University
The Prince Charles Hospital
Princess Alexandra Hospital, Brisbane, Australia
Telethon Kids Institute
Queensland Children's Hospital, Brisbane, Australia
Investigators
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Principal Investigator: PETER D SLY, DSc The University of Queensland
  Study Documents (Full-Text)

Documents provided by The University of Queensland:
Informed Consent Form  [PDF] July 23, 2020

Publications:
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Responsible Party: The University of Queensland
ClinicalTrials.gov Identifier: NCT04496245    
Other Study ID Numbers: BV-2020/19
First Posted: August 3, 2020    Key Record Dates
Last Update Posted: September 4, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Virus Diseases
Broncho-Vaxom
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs