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

NCT04496245 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2022-03-09

No results posted yet for this study

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

Interventions

DRUG

Broncho-Vaxom®

Broncho-Vaxom adult capsules® (OM85)

Sponsors & Collaborators

  • Griffith University

    collaborator OTHER

  • The Prince Charles Hospital

    collaborator OTHER_GOV

  • Princess Alexandra Hospital, Brisbane, Australia

    collaborator OTHER

  • Telethon Kids Institute

    collaborator OTHER

  • Queensland Children's Hospital

    collaborator OTHER_GOV

  • The University of Queensland

    lead OTHER

Principal Investigators

  • PETER D SLY, DSc · The University of Queensland

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-08-24
Primary Completion
2021-06-30
Completion
2021-09-30

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04496245 on ClinicalTrials.gov