| Trial registration number
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NCT04496245 |
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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https://clinicaltrials.gov/show/NCT04496245
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First author
Last imported at : April 6, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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PETER D SLY, Dsc
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Contact
Last imported at : April 6, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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p.sly@uq.edu.au
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Registration date
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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2020-08-03
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Recruitment status
Last imported at : March 12, 2022, midnight
Source : ClinicalTrials.gov
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Completed
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Study design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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RCT
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Allocation
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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Randomized
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Design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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Parallel
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Masking
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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Open label
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Center
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov
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multi-center
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Study aim
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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Prevention
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Inclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov
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inclusion criteria:
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.
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Exclusion criteria
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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participants who meet any of these criteria are not eligible for enrolment:
- staff with prior cov infection necessitating workforce removal
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Number of arms
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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2
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Funding
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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The University of Queensland
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Inclusion age min
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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18
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Inclusion age max
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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100
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Countries
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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Australia
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Type of patients
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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Health workers
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Severity scale
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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N/A
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Total sample size
Last imported at : April 6, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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59
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primary outcome
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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Acute Respiratory Infection necessitating workforce removal
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Notes
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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None
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Phase
Last imported at : Feb. 25, 2021, 7:58 p.m.
Source : ClinicalTrials.gov
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Phase 3
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Arms
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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[{"arm_notes": "Commencing in Month 3, with 3 months follow-up off treatment", "treatment_id": 923, "treatment_name": "Om85", "treatment_type": "Others pharmacological treatment", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "Commencing on day 0, with 3 months follow-up off treatment.", "treatment_id": 923, "treatment_name": "Om85", "treatment_type": "Others pharmacological treatment", "pharmacological_treatment": "Pharmacological treatment"}]
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