COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04327206

Prof Nigel Curtis, MBBS PhD

nigel.curtis@rch.org.au

2020-03-31

Completed

RCT

Randomized

Parallel

Blind label

multi-center

Prevention

inclusion criteria: - over 18 years of age - healthcare worker - this is defined as anyone who works in a healthcare setting or has face to face contact with patients. - provide a signed and dated informed consent form - australian sites only: if annual influenza vaccination is available, receiving the flu vaccine is an eligibility requirement. the flu vaccine will be required a minimum of 3 days in advance of randomisation in the brace trial. - pre-randomisation blood collected

- has any bcg vaccine contraindication - fever or generalised skin infection (where feasible, randomisation can be delayed until cleared) - weakened resistance toward infections due to a disease in/of the immune system - receiving medical treatment that affects the immune response or other immunosuppressive therapy in the last year. - these therapies include systemic corticosteroids (≥20 mg for ≥2 weeks), non-biological immunosuppressant (also known as 'dmards'), biological agents (such as monoclonal antibodies against tumour necrosis factor (tnf)-alpha). - people with congenital cellular immunodeficiencies, including specific deficiencies of the interferon-gamma pathway - people with malignancies involving bone marrow or lymphoid systems - people with any serious underlying illness (such as malignancy) - nb: people with cardiovascular disease, hypertension, diabetes, and/or chronic respiratory disease are eligible if not immunocompromised, and if they meet other eligibility criteria - known or suspected hiv infection,even if they are asymptomatic or have normal immune function. - this is because of the risk of disseminated bcg infection - people with active skin disease such as eczema, dermatitis or psoriasis at or near the site of vaccination - a different adjacent site on the upper arm can be chosen if necessary - pregnant - although there is no evidence that bcg vaccination is harmful during pregnancy, it is a contra-indication to bcg vaccination. therefore, we will exclude women who think they could be pregnant or are planning to become pregnant within the next month. - uk specific: although there is no evidence that bcg vaccination is harmful during pregnancy, it is a contra-indication to bcg vaccination. therefore, we will exclude women of childbearing potential (wocbp) who think they could be pregnant. - spain specific: if the patient is female, and of childbearing potential, she must have a negative pregnancy test at the time of inclusion and practice a reliable method of birth control for 30 days after receiving the bcg vaccination. - another live vaccine administered in the month prior to randomisation - require another live vaccine to be administered within the month following bcg randomisation - if the other live vaccine can be given on the same day, this exclusion criteria does not apply - known anaphylactic reaction to any of the ingredients present in the bcg vaccine - previous active tb disease - currently receiving long term (more than 1 month) treatment with isoniazid, rifampicin or quinolone as these antibiotics have activity against mycobacterium bovis - previous adverse reaction to bcg vaccine (significant local reaction (abscess) or suppurative lymphadenitis) - bcg vaccine given within the last year - have previously had a sars-cov-2 positive test result (positive pcr on a respiratory sample or a positive sars-cov-2 diagnostic antigen test approved by the local jurisdiction's public health policy) - already part of this trial, recruited at a different site/hospital. - participation in another covid-19 prevention trial - have previously received a covid-19-specific vaccine

2

Murdoch Childrens Research Institute

18

100

Australia;Brazil;Netherlands;Spain;United Kingdom

Health workers

N/A

6828

Severe COVID-19 incidence over 6 months;Symptomatic COVID-19 by 6 months

None

Phase 3

[{"arm_notes": "1", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}, {"arm_notes": "1", "treatment_id": 186, "treatment_name": "Bcg vaccine", "treatment_type": "Non covid vaccine", "pharmacological_treatment": "Non covid vaccine"}]