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| Column | Value |
|---|---|
| Trial registration number | NCT04393792 |
|
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
|
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First author
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
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Contact
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Afroze.Khan@nhs.net |
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Registration date
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
2020-05-19 |
|
Recruitment status
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Recruiting |
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Study design
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
RCT |
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Allocation
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Randomized |
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Design
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Parallel |
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Masking
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Open label |
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Center
Last imported at : March 15, 2023, 4 a.m. Source : ClinicalTrials.gov |
single-center |
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Study aim
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Prevention |
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Inclusion criteria
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
inclusion criteria: - healthcare worker or patient on a general ward who has had a positive covid-19 test or a person who is co-residing with an affected staff member or patient who is now at home in self-isolation. - capable of giving informed consent - able to self-administer the sinus rinses and mouth washes - able to have healthcare professional-led swabs or self-administer the oral and nasopharyngeal swabs - aged 18 years and over. |
|
Exclusion criteria
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
- not capable of giving informed consent - unable to self-administer the sinus rinses and mouth washes - unable to have healthcare professional-led swabs or self-administer the oral, nasal and/or nasopharyngeal swabs - unable to send swabs to the study team via the approved methods described in participant information leaflet and protocol - under 18 years of age. - known hypersensitivity to iodine - at risk of aspiration due to an unsafe swallow - hyperthyroidism or other manifest thyroid diseases - herpetiform dermatitis (duhring's disease) - planned or undergoing radioiodine treatment - actively breastfeeding - pregnant |
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Number of arms
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
4 |
|
Funding
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Hampshire Hospitals NHS Foundation Trust |
|
Inclusion age min
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
18 |
|
Inclusion age max
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
None |
|
Countries
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
United Kingdom |
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Type of patients
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Close contacts to covid patients |
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Severity scale
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
N/A |
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Total sample size
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
40 |
|
primary outcome
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Change in viral load in the oral and nasopharyngeal cavity |
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Notes
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
None |
|
Phase
Last imported at : Feb. 25, 2021, 7:58 p.m. Source : ClinicalTrials.gov |
Phase 1 |
|
Arms
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
[{"arm_notes": "Prevention for Covid19 patient coresiding/Treatment.", "treatment_id": 1015, "treatment_name": "Povidone-iodine", "treatment_type": "Mouthwash", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "Prevention for Covid19 patient coresiding/Treatment.", "treatment_id": 1015, "treatment_name": "Povidone-iodine", "treatment_type": "Mouthwash", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "Prevention for Covid19 patient coresiding/Treatment.", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}, {"arm_notes": "Prevention for Covid19 patient coresiding/Treatment.", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}] |