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Trial - EUCTR2020-001721-31-GB


Column Value
Trial registration number EUCTR2020-001721-31-GB
Full text link
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register

First author
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register

Hampshire Hospitals NHS TRust - Chief Investigator

Contact
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register

afroze.khan@nhs.net

Registration date
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register

2020-04-27

Recruitment status
Last imported at : Jan. 4, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

Recruiting

Study design
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register

RCT

Allocation
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register

Randomized

Design
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register

Parallel

Masking
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register

Not reported

Center
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register

single-center

Study aim
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register

Treatment

Inclusion criteria
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register

Staff who have tested positive for COVID -19 AND in isolation at home. Patients who have been tested positive for Covid-19 on general wards or about to be discharged who are well enough to self administer nasal washes. Household member of affected staff member and household members of affected patients on general ward once discharged to home self-isolation 18 years and over

Exclusion criteria
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register

Known hypersensitivity to Iodine Those at risk of aspiration due to unsafe swallow Those unable to perform treatment themselves Under 18 years of age

Number of arms
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register

2

Funding
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register

Hampshire Hospitals NHS TRust

Inclusion age min
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register

18

Inclusion age max
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register

None

Countries
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register

United Kingdom

Type of patients
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register

Mild/moderate disease at enrollment

Severity scale
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register

2: Mild/moderate disease at enrollment

Total sample size
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register

40

primary outcome
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register

The primary outcome measure will be the change in Viral load in the two arms as measured by real time PCR.

Notes
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register

Declared number of arm (4.0) differs from found arms (2.0)

Phase
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register

Phase 2

Arms
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register

[{"arm_notes": "", "treatment_id": 1015, "treatment_name": "Povidone-iodine", "treatment_type": "Mouthwash", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]