Ignite Creation Date:
2025-12-24 @ 3:14 PM
Ignite Modification Date:
2025-12-25 @ 1:36 PM
Study NCT ID:
NCT04393792
Status:
UNKNOWN
Last Update Posted:
2021-09-17
First Post:
2020-05-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
SINUS WASH Pilot Study in Adults Testing Positive for COVID-19
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011206', 'term': 'Povidone-Iodine'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D007466', 'term': 'Iodophors'}, {'id': 'D017613', 'term': 'Iodine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D011145', 'term': 'Polyvinyls'}, {'id': 'D014753', 'term': 'Vinyl Compounds'}, {'id': 'D000475', 'term': 'Alkenes'}, {'id': 'D006839', 'term': 'Hydrocarbons, Acyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011205', 'term': 'Povidone'}, {'id': 'D011760', 'term': 'Pyrrolidinones'}, {'id': 'D011759', 'term': 'Pyrrolidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D010969', 'term': 'Plastics'}, {'id': 'D011108', 'term': 'Polymers'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D001697', 'term': 'Biomedical and Dental Materials'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'unblinded parallel group design with 1:1 randomised allocation to treatment or control'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-05-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2022-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-09-16', 'studyFirstSubmitDate': '2020-05-18', 'studyFirstSubmitQcDate': '2020-05-18', 'lastUpdatePostDateStruct': {'date': '2021-09-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in viral load in the oral and nasopharyngeal cavity', 'timeFrame': 'Day 0, 2, 3, 7, 14', 'description': 'viral load as measured by real time polymerase chain reaction (PCR)'}], 'secondaryOutcomes': [{'measure': 'Symptom severity in primary participants and co-residents', 'timeFrame': 'Days 0 to 14', 'description': 'Visual analogue score 1-5 per symptom via a smartphone app'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COVID-19', 'sinus rinse', 'mouth wash', 'povidone-iodine', 'coronavirus', 'Wuhan'], 'conditions': ['Coronavirus Infection']}, 'descriptionModule': {'briefSummary': 'COVID-19 is highly infectious and transmission of the virus is thought to be similar to that of influenza which can be transferred through droplets released when a person coughs, sneezes or talks. Studies have shown that nasal rinsing and mouth washes may be an important way to deliver treatments that could reduce the amount of a virus that is present in the nose and mouth. This also could mean that there is less virus available to pass on to others. We want to see if the use of nose rinses and mouth washes using Povidone-Iodine will reduce the the amount of virus in the nose and throat of people who have tested positive for COVID-19 disease and also reduce the spread of infection within their household.', 'detailedDescription': "COVID-19 is highly infectious and transmission of the virus is thought to be similar to that of influenza which can be transferred through droplets released when a person coughs, sneezes or talks. Studies have shown that nasal rinsing and mouth washes may be an important way to deliver treatments that could reduce the amount of a virus that reaches other parts of the body. This also could mean that there is less virus available to pass on to others.\n\nWe want to see if the use of nasal rinsing and mouth washes will reduce the spread of infection within your household by reducing and removing the virus from your mouth and nose.\n\nOnce the participants have been recruited they will be randomly allocated to one of two groups. Each arm will have the same number of participants. The two arms will be :\n\n1. nose rinse and mouthwash with Isotonic saline alone. This will be the control arm.\n2. nose rinse and mouthwash with Povidone-Iodine taken 3 times a days for three days.\n\nBefore treatment begins, each participant will have one pre-treatment swab of the back of the nose and the back of the throat taken.\n\nOnce allocated each participant will be asked to have 4 further swabs of the mouth and nose taken on days 2,4,7 \\& 14.\n\nParticipants will be patients and healthcare staff who have tested positive for COVID-19. Healthcare staff who are self isolating will also asked their co-residents/family members at home to take the treatment and provide swabs in the same manner.\n\nParticipants who are patients and are admitted to hospital will be well enough to perform the nasal rinses and mouth washes as treatments and provide the same swabs.\n\nAll participants will be provided with informational videos on how to do the treatments and how to take the swabs. Participants who are not healthcare staff will have swabs taken as part of the local drive through testing service.\n\nAll participants will be asked to download a free smartphone app (Umotif) to upload information about daily symptoms and whether they have provided swabs on the required days.\n\nThe swabs will be tested for the amount of virus in the labs at Hampshire Hospitals NHS Foundation Trust and analysed to determine if the treatment arm of Povidone-Iodine is reducing the amount of virus compared to the isotonic saline arm.\n\nAll results will be anonymised prior to analysis. The study team will know the participants' study-specific data; no personal data about participants will be used without their explicit consent and only for the purposes of protocol adherence and data to answer the study question.\n\nOnce the last swab has been taken and delivered to the laboratory, the trial will have ended for that participant. Results of the swabs will be part of the study data and collated in readiness for analysis by the study statistician.\n\nThe results will be made available for peer-reviewed publication and presentation at conferences."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 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.\n* capable of giving informed consent\n* able to self-administer the sinus rinses and mouth washes\n* able to have healthcare professional-led swabs OR self-administer the oral and nasopharyngeal swabs\n* aged 18 years and over.\n\nExclusion Criteria:\n\n* not capable of giving informed consent\n* unable to self-administer the sinus rinses and mouth washes\n* unable to have healthcare professional-led swabs OR self-administer the oral, nasal and/OR nasopharyngeal swabs\n* unable to send swabs to the study team via the approved methods described in participant information leaflet and protocol\n* under 18 years of age.\n* known hypersensitivity to Iodine\n* at risk of aspiration due to an unsafe swallow\n* hyperthyroidism or other manifest thyroid diseases\n* herpetiform dermatitis (Duhring's disease)\n* planned or undergoing radioiodine treatment\n* actively Breastfeeding\n* pregnant"}, 'identificationModule': {'nctId': 'NCT04393792', 'briefTitle': 'SINUS WASH Pilot Study in Adults Testing Positive for COVID-19', 'organization': {'class': 'OTHER', 'fullName': 'Hampshire Hospitals NHS Foundation Trust'}, 'officialTitle': 'Can a Sinus Rinse and Mouth Wash Reduce Viral Load in COVID-19 Positive Individuals and Their Co-residents?', 'orgStudyIdInfo': {'id': 'SPON-AK-0420'}, 'secondaryIdInfos': [{'id': '2020-001721-31', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Povidone-Iodine', 'description': '0.23% sinus rinse and mouthwash three times daily (tds) for days 1-3 of study', 'interventionNames': ['Drug: Povidone-Iodine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Normal Saline', 'description': 'sinus rinse and mouthwash three times daily (tds) for days 1-3 of study', 'interventionNames': ['Drug: Normal saline']}], 'interventions': [{'name': 'Povidone-Iodine', 'type': 'DRUG', 'otherNames': ['Videne Antiseptic Solution'], 'description': '0.23% three times daily (tds) for 3 days', 'armGroupLabels': ['Povidone-Iodine']}, {'name': 'Normal saline', 'type': 'DRUG', 'description': '0.9% three times daily (tds) for 3 days', 'armGroupLabels': ['Normal Saline']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'RG24 9NA', 'city': 'Basingstoke', 'state': 'Hampshire', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Afroze Khan, MBBS MRCS', 'role': 'CONTACT'}, {'name': 'Matthew Dryden', 'role': 'CONTACT'}], 'facility': 'Hampshire Hospitals NHS Foundation Trust', 'geoPoint': {'lat': 51.26249, 'lon': -1.08708}}], 'centralContacts': [{'name': 'Afroze Khan, MBBS MRCS', 'role': 'CONTACT', 'email': 'Afroze.Khan@nhs.net', 'phone': '+447885903693'}, {'name': 'Matthew Dryden', 'role': 'CONTACT', 'email': 'matthew.dryden@hhft.nhs.uk'}], 'overallOfficials': [{'name': 'Afroze Khan, MBBS MRCS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hampshire Hospitals NHS Foundation Trust'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hampshire Hospitals NHS Foundation Trust', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}