| Trial registration number
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ISRCTN48554326 |
Full text link
Last imported at : Sept. 1, 2021, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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https://www.isrctn.com/ISRCTN48554326
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First author
Last imported at : June 17, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Prof Anneli Uusküla
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Contact
Last imported at : June 17, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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anneli.uuskula@ut.ee
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Registration date
Last imported at : June 17, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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2021-06-14
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Recruitment status
Last imported at : Feb. 11, 2022, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Not recruiting
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Study design
Last imported at : June 17, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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RCT
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Allocation
Last imported at : June 17, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Randomized
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Design
Last imported at : June 17, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Cluster
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Masking
Last imported at : June 17, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Blind label
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Center
Last imported at : June 17, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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unclear
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Study aim
Last imported at : June 17, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Prevention
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Inclusion criteria
Last imported at : June 17, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Index case: 1.Confirmed case of COVID-19 infection with at least one SARS-CoV-2 PCR negative person household contact 2. Aged =16 years Household contacts: 1. SARS-CoV-2 PCR negative household contact of the index case 2. Aged =16 years
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Exclusion criteria
Last imported at : Sept. 1, 2021, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Current exclusion criteria as of 27/08/2021: 1. Aged <16 years 2. Pregnancy 3. Use of active cancer treatment 4. Use of biological treatment 5. Previously confirmed COVID-19 6. Any organ transplantation 7. Single person household 8. Requires hospitalisation prior to study start 9. Required to take regular medications administered by inhalation, or via the naso- and oropharyngeal route 10. Asthma 11. Known allergies to BioBlock components Previous exclusion criteria: 1. Aged <16 years 2. Pregnancy 3. Use of active cancer treatment 4. Use of biological treatment 5. Previously vaccinated against COVID-19 6. Previously confirmed COVID-19 7. Any organ transplantation 8. Single person household 9. Requires hospitalisation prior to study start 10. Required to take regular medications administered by inhalation, or via the naso- and oropharyngeal route 11. Asthma 12. Known allergies to BioBlock components
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Number of arms
Last imported at : June 17, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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2
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Funding
Last imported at : June 17, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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University of Tartu
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Inclusion age min
Last imported at : June 17, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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16
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Inclusion age max
Last imported at : June 17, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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100
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Countries
Last imported at : June 17, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Estonia
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Type of patients
Last imported at : June 17, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Close contacts to covid patients
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Severity scale
Last imported at : June 17, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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N/A
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Total sample size
Last imported at : Sept. 1, 2021, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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342
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primary outcome
Last imported at : June 17, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Rate of COVID-19 infection in household members measured using PCR swab taken at 1 and 14 days
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Notes
Last imported at : June 17, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Phase
Last imported at : June 17, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Phase 2
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Arms
Last imported at : June 17, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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[{"arm_notes": "Nasal spray;248 household contacts and 124 SARS-CoV-2 positive index patients ", "treatment_id": 313, "treatment_name": "Colostrum sars-cov-2 antiviral antibodies", "treatment_type": "Advanced therapy medicinal products (atmp)", "pharmacological_treatment": "Biological treatment"}, {"arm_notes": "Nasal spray;248 household contacts and 124 SARS-CoV-2 positive index patients ", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]
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