Condition category
Infections and Infestations
Date applied
21/05/2020
Date assigned
22/05/2020
Last edited
22/05/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
COVID-19 is a condition caused by the coronavirus (called SARS-CoV-2) that was first identified in late 2019. This virus can infect the respiratory (breathing) system. Some people do not have symptoms but can carry the virus and pass it on to others. People who have developed the condition may develop a fever and/or a continuous cough among other symptoms. This can develop into pneumonia. Pneumonia is a chest infection where the small air pockets of the lungs, called alveoli, fill with liquid and make it more difficult to breathe.

In 2020, the virus has spread to many countries around the world and neither a vaccine against the virus or specific treatment for COVID-19 has yet been developed. As of March 2020, it is advised that people minimize travel and social contact, and regularly wash their hands to reduce the spread of the virus.

Groups who are at a higher risk from infection with the virus, and therefore of developing COVID-19, include people aged over 70 years, people who have long-term health conditions (such as asthma or diabetes), people who have a weakened immune system and people who are pregnant. People in these groups, and people who might come into contact with them, can reduce this risk by following the up-to-date advice to reduce the spread of the virus.

Fluids (saliva and mucus) in the mouth, throat, and lungs of COVID-19 sufferers contain huge amounts of active SARS-CoV-2 virus; transmission of disease occurs when these fluids are coughed out or spread during normal breathing. Reducing the viral load in these areas may therefore reduce transmission of the disease.

The study tests the hypothesis that a common medical disinfectant, aqueous 0.5% povidone iodine (PVP-I) solution, administered to the mouth and nose of confirmed COVID-19 sufferers will reduce the quantity of the virus in the fluid lining those areas.

Who can participate?
Adults ≥ 18 years old but ≤ 75 years old, recently hospitalised with COVID-19 disease.

What does the study involve?
The trial will administer PVP-I to the mouth, nose and throat of proven COVID-19 patients who are not dependent on any ventilation. Viral levels from the mouth and nose will be determined immediately before and at several time points up to 2 hours after treatment in 2 different ways to quantify the reduction in virus from baseline over time in response to PVP-I use. Some patients will undergo the same process, but using water as a control.

What are the possible benefits and risks of participating?
No benefits are expected to be received by a recipient of the PVP-I, as no curative intent is planned for the intervention, however, if proven, the PVP-I may stop patients from spreading the disease on to others. The risks to patients are very small. There is an exceptionally small risk of allergy (at least less than one in 1000) which might manifest as a burning sensation in the mouth or nose and swelling. There is a small theoretical risk of interference with the thyroid gland, although the dose received is very small, so that is why patients with thyroid disorders are excluded.

Where is the study run from?
Royal Surrey County Hospital (UK)

When is the study starting and how long is it expected to run for?
March 2020 to July 2020

Who is funding the study?
1. British Association of Oral and Maxillofacial Surgeons
2. Royal Surrey County Hospital Charitable Fund
3. Surrey Perioperative, Anaesthesia & Critical Care Collaborative Research Group

Who is the main contact?
Unfortunately, this study is not recruiting public volunteers at this time. This is because the research isn’t ready for volunteers yet or the researchers are directly identifying volunteers in certain areas or hospitals. Please do not contact the research team as they will not be able to respond. For more information about COVID-19 research, visit the Be Part of Research homepage.

Trial website

http://www.spacer.org.uk/pico/

Contact information

Type

Scientific

Primary contact

Dr Justin Kirk-Bayley

ORCID ID

http://orcid.org/0000-0001-9493-045X

Contact details

Surrey Perioperative
Anaesthesia & Critical Care Collaborative Research Group
Royal Surrey County Hospital
Egerton Road
Guildford
GU2 7XX
United Kingdom
01483 577 122 ext 4088
pico@spacer.org.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

IRAS 283182

Study information

Scientific title

A pilot study of virucidal activity of povidone-iodine (PVP-I) 0.5% aqueous solution oral/nasal spray and mouthwash in people with COVID-19 and confirmed oral/nasal shedding of SARS-CoV-2

Acronym

PICO

Study hypothesis

SARS-CoV-2 is the virus causing the current COVID-19 pandemic; reducing transmission of the disease is critical globally. Fluids (saliva and mucus) in upper airways of COVID-19 sufferers contain huge amounts of active SARS-CoV-2; transmission of disease occurs when these fluids are coughed out or spread during normal breathing. Reducing the viral load in these areas may therefore reduce transmission of the disease.

The study tests the hypothesis that administration of a povidone iodine (PVP-I) nasal spray and mouthwash to COVID-19 sufferers reduces the SARS-CoV-2 viral titres found in their saliva and nose when compared to a water nasal spray and mouthwash.

Ethics approval

Not provided at time of registration

Study design

Single-arm non-randomised open-label uncontrolled interventional study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a patient information sheet

Condition

COVID-19 (SARS-CoV-2 infection)

Intervention

The study will be conducted on 25 participants in a hospital setting. Each study participant will give a sample of saliva then use a spray or mouthwash/gargle of PVP-I for one minute followed by PVP-I atomised into each nostril using a simple device, not dissimilar to using a commercial nasal spray. Over the next 2 hours they will provide 5 further saliva samples for analysis.

5 of the 25 patients will undergo the same process, but using water as a control.

Intervention type

Drug

Phase

Not Applicable

Drug names

Povidone iodine 0.5%

Primary outcome measure

Amounts of cultured SARS-CoV-2 and quantitative PCR results of viral RNA in saliva and nasal samples at baseline, and 5 further time points up to 2 h after administration. Results will be expressed as actual counts per ml saliva and the mean log reduction after application of PVP-I determined, taking into account any dilution effect by the mouthwash or spray which will be analysed in a control group given water instead of PVP-I

Secondary outcome measures

Salivary viral loads after administration of PVP-I nasal spray or PVP-I mouthwash, at baseline, 5, and 20 min

Overall trial start date

15/03/2020

Overall trial end date

30/07/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Adults aged ≥18 years and ≤75 years
2. Have confirmed COVID-19 symptoms and symptom onset within the past 10 days
3. Recently (within last 3-4 days) hospitalised with COVID-19 disease
4. COVID-19 disease proven by PCR testing for SARS-CoV-2 within the last 4 days
5. Capable of using a nasal spray device and the mouthwash required by the trial
6. Capacity and capability to give informed consent to take part in the trial

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

25

Participant exclusion criteria

1. Known sensitivity to PVP-I aqueous antiseptic solution or any of its listed excipients
2. Previously diagnosed thyroid disease
3. Chronic renal failure (stage ≥3 by eGFR MDRD)
4. Acute renal failure (KDIGO ≥stage 2: creatinine ≥2x baseline)
5. Known pregnancy or currently breastfeeding
6. Current requirement for invasive or non-invasive ventilation or planned within next 6 hours
7. Patient undergoing or soon to undergo radioiodine treatment
8. Known dermatitis herpetiformis (Duhring's disease)
9. Current participation in research that is designed to, or is expected to alter the COVID-19 disease course or viral load.
10. Inability to communicate in English or read English

Recruitment start date

01/06/2020

Recruitment end date

30/09/2020

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Royal Surrey County Hospital
Egerton Road
Guildford
GU2 7XX
United Kingdom

Sponsor information

Organisation

Royal Surrey County Hospital NHS Foundation Trust

Sponsor details

Egerton Road
Guildford
Surrey
Guildford
GU2 7XX
United Kingdom
+44 (0)1483 688 539
k.penhaligon@nhs.net

Sponsor type

Hospital/treatment centre

Website

http://www.royalsurrey.nhs.uk/

Funders

Funder type

Research council

Funder name

British Association of Oral and Maxillofacial Surgeons

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Royal Surrey County Hospital Charitable Fund

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Surrey Perioperative, Anaesthesia & Critical Care Collaborative Research Group

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal.

IPD sharing statement:
All data generated or analysed during this study will be included in the subsequent results publication.

Intention to publish date

30/09/2020

Participant level data

Other

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

NHW 22/05/2020: Trial’s existence confirmed by British Association of Oral and Maxillofacial Surgeons.