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Reducing acute severe respiratory events in health care workers during the Covid-19 pandemic with OM85

Reducing acute severe respiratory events in health care workers during the Covid-19 pandemic with OM85

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12620000473965
Acronym
COVID RASP
Enrollment
61
Registered
2020-04-15
Start date
2020-08-18
Completion date
2021-03-02
Last updated
2025-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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.

Sponsors

The University of Queensland
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

health care workers in the front line of assessing and caring for patients with suspected or proved Covid-19 infection

Exclusion criteria

health care workers with previous Covid-19 infection necessitating workforce removal.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026