CompletedPhase 3ACTRN12620000473965

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


Sponsor

The University of Queensland

Enrollment

1,000 participants

Start Date

Aug 18, 2020

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria1

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

Exclusion Criteria1

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

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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

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.


Locations(3)

Queensland Children's Hospital - South Brisbane

QLD, Australia

The Prince Charles Hospital - Chermside

QLD, Australia

Princess Alexandra Hospital - Woolloongabba

QLD, Australia

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ACTRN12620000473965