drugset / Trial / NCT04496245
Reducing Acute Severe Respiratory Events in Health Care Workers During the Covid-19 Pandemic With OM85
Phase 3
Completed
59 enrolled
The University of Queensland
Griffith University · collabPrincess Alexandra Hospital, Brisbane, Australia · collabQueensland Children's Hospital · collabTelethon Kids Institute · collabThe Prince Charles Hospital · collab
RandomizedParallel-groupOpen-labelPrevention
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.
Timeline
- Start
- 2020-08-24
- Primary completion
- 2021-06-30
- Completion
- 2021-09-30
Publications
- Background 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.
- 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Broncho-Vaxom | Other / unclassified | 7 mg | — |