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

• Status: Active, not recruiting
• Trial end date: 2021-09-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: The University of Queensland
• Collaborators: Griffith University; Princess Alexandra Hospital, Brisbane, Australia; Queensland Children's Hospital, Australia; Queensland Children's Hospital, Brisbane, Australia; Telethon Kids Institute; The Prince Charles Hospital
• Treatments: Broncho-Vaxom

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