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

NCT04496245 | Completed Phase 3 DMC

• 1 other identifier: BV-2020/19
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 3

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.

Conditions

Respiratory Viral Infection; Covid19

Outcome Measures

Primary Outcomes (1)

• 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.

  3 months

Secondary Outcomes (6)

• Time to ARI necessitating workforce removal.

  12 months

• The proportion of Health Care Workers contracting an Acute Respiratory Infection necessitating workforce removal

  12 months

• The proportion of HCW with documented Cov infection.

  12 months

• Time to Lower respiratory infection (LRI) necessitating workforce removal.

  12 months

• The proportion of Health Care Workers contracting a LRI necessitating workforce removal

  12 months

Study Arms (2)

Wait-list control

ACTIVE COMPARATOR

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®

Initial treatment wtih OM85

EXPERIMENTAL

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®

Interventions

Broncho-Vaxom® DRUG

Broncho-Vaxom adult capsules® (OM85)

Also known as: OM85

Initial treatment wtih OM85; Wait-list control

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants who meet all of the following criteria are eligible for enrolment:
• 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
• Participants who, in the opinion of the investigator, are able to comply with the protocol for its duration,
• Written informed consent signed and dated according to local regulations.

You may not qualify if:

• Participants who meet any of these criteria are not eligible for enrolment:
• Staff with prior COV infection necessitating workforce removal

Sponsors & Collaborators

• The University of Queensland: lead
• Griffith University: collaborator
• The Prince Charles Hospital: collaborator
• Princess Alexandra Hospital, Brisbane, Australia: collaborator
• Telethon Kids Institute: collaborator
• Queensland Children's Hospital: collaborator

Study Sites (3)

The Prince Charles Hospital

Brisbane, Queensland, 4032, Australia

Location

The Princess Alexandra Hospital

Brisbane, Queensland, 4102, Australia

Location

Queensland Children's Hospital

South Brisbane, Queensland, 4101, Australia

Location

Related Publications (3)

• 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. No abstract available.

  PMID: 31185221 BACKGROUND

• 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.

  PMID: 29561355 BACKGROUND

• The Lancet. COVID-19: protecting health-care workers. Lancet. 2020 Mar 21;395(10228):922. doi: 10.1016/S0140-6736(20)30644-9. No abstract available.

  PMID: 32199474 BACKGROUND

MeSH Terms

Conditions

COVID-19

Interventions

Broncho-Vaxom

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• PETER D SLY, DSc

  The University of Queensland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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 \[High risk, lower risk\].
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: July 26, 2020
• First Posted: August 3, 2020
• Study Start: August 24, 2020
• Primary Completion: June 30, 2021
• Study Completion: September 30, 2021
• Last Updated: March 9, 2022

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

AU (3)