Ignite Creation Date:
2025-12-24 @ 1:41 PM
Ignite Modification Date:
2025-12-30 @ 11:59 AM
Study NCT ID:
NCT05950295
Status:
COMPLETED
Last Update Posted:
2023-07-18
First Post:
2023-07-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intranasal Lavage With Hypochlorous Acid Safely Reduces the Symptoms in the Ambulatory Patient With COVID-19.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 88}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2021-04-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-15', 'studyFirstSubmitDate': '2023-07-15', 'studyFirstSubmitQcDate': '2023-07-15', 'lastUpdatePostDateStruct': {'date': '2023-07-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction in symptoms of COVID-19', 'timeFrame': '40 days from start of nasal lavage', 'description': 'Change in sense of smell, fever profile, nasal congestion, and headache'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['intranasal lavage'], 'conditions': ['COVID-19']}, 'referencesModule': {'references': [{'pmid': '32224308', 'type': 'BACKGROUND', 'citation': 'Joynt GM, Wu WK. Understanding COVID-19: what does viral RNA load really mean? Lancet Infect Dis. 2020 Jun;20(6):635-636. doi: 10.1016/S1473-3099(20)30237-1. Epub 2020 Mar 27. No abstract available.'}, {'type': 'BACKGROUND', 'citation': 'Waradon S, Ni H, Christophe B, Marjjin B. SARS-CoV-2 Entry Genes Are Most Highly Expressed in Nasal Goblet and Ciliated Cells Within Human Airway.Nature Medicine. 2020. Mar.arXiv.org.'}, {'pmid': '17492050', 'type': 'BACKGROUND', 'citation': 'Wang L, Bassiri M, Najafi R, Najafi K, Yang J, Khosrovi B, Hwong W, Barati E, Belisle B, Celeri C, Robson MC. Hypochlorous acid as a potential wound care agent: part I. Stabilized hypochlorous acid: a component of the inorganic armamentarium of innate immunity. J Burns Wounds. 2007 Apr 11;6:e5.'}, {'pmid': '17492051', 'type': 'BACKGROUND', 'citation': 'Robson MC, Payne WG, Ko F, Mentis M, Donati G, Shafii SM, Culverhouse S, Wang L, Khosrovi B, Najafi R, Cooper DM, Bassiri M. Hypochlorous Acid as a Potential Wound Care Agent: Part II. Stabilized Hypochlorous Acid: Its Role in Decreasing Tissue Bacterial Bioburden and Overcoming the Inhibition of Infection on Wound Healing. J Burns Wounds. 2007 Apr 11;6:e6.'}, {'pmid': '28458509', 'type': 'BACKGROUND', 'citation': 'Stroman DW, Mintun K, Epstein AB, Brimer CM, Patel CR, Branch JD, Najafi-Tagol K. Reduction in bacterial load using hypochlorous acid hygiene solution on ocular skin. Clin Ophthalmol. 2017 Apr 13;11:707-714. doi: 10.2147/OPTH.S132851. eCollection 2017.'}, {'pmid': '32722777', 'type': 'BACKGROUND', 'citation': 'Farrell NF, Klatt-Cromwell C, Schneider JS. Benefits and Safety of Nasal Saline Irrigations in a Pandemic-Washing COVID-19 Away. JAMA Otolaryngol Head Neck Surg. 2020 Sep 1;146(9):787-788. doi: 10.1001/jamaoto.2020.1622. No abstract available.'}, {'pmid': '30705369', 'type': 'BACKGROUND', 'citation': 'Ramalingam S, Graham C, Dove J, Morrice L, Sheikh A. A pilot, open labelled, randomised controlled trial of hypertonic saline nasal irrigation and gargling for the common cold. Sci Rep. 2019 Jan 31;9(1):1015. doi: 10.1038/s41598-018-37703-3.'}, {'pmid': '33538761', 'type': 'BACKGROUND', 'citation': 'Guenezan J, Garcia M, Strasters D, Jousselin C, Leveque N, Frasca D, Mimoz O. Povidone Iodine Mouthwash, Gargle, and Nasal Spray to Reduce Nasopharyngeal Viral Load in Patients With COVID-19: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2021 Apr 1;147(4):400-401. doi: 10.1001/jamaoto.2020.5490.'}, {'pmid': '25421399', 'type': 'BACKGROUND', 'citation': 'Hakim H, Thammakarn C, Suguro A, Ishida Y, Kawamura A, Tamura M, Satoh K, Tsujimura M, Hasegawa T, Takehara K. Evaluation of sprayed hypochlorous acid solutions for their virucidal activity against avian influenza virus through in vitro experiments. J Vet Med Sci. 2015 Feb;77(2):211-5. doi: 10.1292/jvms.14-0413. Epub 2014 Nov 24.'}, {'pmid': '30206371', 'type': 'BACKGROUND', 'citation': 'Ramalingam S, Cai B, Wong J, Twomey M, Chen R, Fu RM, Boote T, McCaughan H, Griffiths SJ, Haas JG. Antiviral innate immune response in non-myeloid cells is augmented by chloride ions via an increase in intracellular hypochlorous acid levels. Sci Rep. 2018 Sep 11;8(1):13630. doi: 10.1038/s41598-018-31936-y.'}, {'pmid': '27558337', 'type': 'BACKGROUND', 'citation': 'Wang G. Chloride flux in phagocytes. Immunol Rev. 2016 Sep;273(1):219-31. doi: 10.1111/imr.12438.'}, {'pmid': '32320008', 'type': 'RESULT', 'citation': 'Spinato G, Fabbris C, Polesel J, Cazzador D, Borsetto D, Hopkins C, Boscolo-Rizzo P. Alterations in Smell or Taste in Mildly Symptomatic Outpatients With SARS-CoV-2 Infection. JAMA. 2020 May 26;323(20):2089-2090. doi: 10.1001/jama.2020.6771.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to determine if intranasal lavage reduces symptoms in adults with COVID-19. The main question is can a hypochlorous acid solution reduce the symptoms of COVID-19.\n\nParticipants will asked to do the following:\n\n* Irrigate each nostril once a day for ten days with a hypochlorous acid solution.\n* Write a daily record of the presence or absence of symptoms such as fever, headache, chills, nausea, or change in sense of smell.\n* After ten days, return the daily log in the mail to the investigator.', 'detailedDescription': 'Methods This study was approved by the Institutional Review Board of Reading Hospital (IRB 036-020) with informed consent obtained from all adult participants. Convenience sampling methodology was utilized for those who met the study criteria inclusive to all gender at ages18 years old and/or older. Excluded participants were those who expressed the desire to not use nasal lavage, women with known pregnancies, and children aged 17 years old and/or younger. The source of enrollees was generated from patients presenting to an ambulatory testing facility for nasopharyngeal swabs for COVID-19. Swab analysis was obtained by reverse transcription-polymerase chain reaction until the COVID-19 antigen specific test (Binax NOW, Abbott Lab) became available for use which allowed a more lenient process for including the Covid-19 positive patients. Each enrolled participant was given a Nasaflo Neti Pot (NeilMed Pharmaceuticals, Inc) with instructions to irrigate each nostril once a day for ten days with the provided hypochlorous solution Vashe Wound Solution (Urgo Medical North America, LLC). Each participant began the daily 120 cc (four -ounce) nasal lavage intervention within 72 hours of their testing. Each participant was given a scripted diary log in which they recorded daily the presence or absence of clinical symptoms such as elevated temperature, fatigue, headache, chills, nausea, and anosmia by noting "yes" or "no." After completing the ten days of nasal lavage, each log was returned to the principal investigator via mail. The participants remained quarantined for the recommended time period of 14 days, and adhered to social distancing, handwashing, and donning of face masks. Throughout the study, each participant was urged to not share their devices with any other individuals. After thirty days from the start of their nasal intervention, participants were telephoned for a follow-up review.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The source of enrollees was generated from persons presenting to one ambulatory testing facility for nasopharyngeal swab testing for COVID-19.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All gender aged 18 years and older.\n* Positive COVID-19 specific antigen test resulted within 72 hours.\n\nExclusion Criteria:\n\n* Persons with known current pregnancy\n* Persons less than or equal to 17 years of age.\n* Persons currently using any intranasal medications or agents\n* Persons unwilling to use nasal lavage.'}, 'identificationModule': {'nctId': 'NCT05950295', 'briefTitle': 'Intranasal Lavage With Hypochlorous Acid Safely Reduces the Symptoms in the Ambulatory Patient With COVID-19.', 'organization': {'class': 'OTHER', 'fullName': 'Monique Lisa Abner'}, 'officialTitle': 'Intranasal Lavage With Hypochlorous Acid Safely Reduces the Symptoms in the Ambulatory Patient With COVID-19.', 'orgStudyIdInfo': {'id': 'IRB 036-020'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Intranasal lavage with hypochlorous acid solution', 'type': 'OTHER', 'description': 'intranasal lavage for ten days'}]}, 'contactsLocationsModule': {'locations': [{'zip': '19610', 'city': 'Reading', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Tower Health/Reading Hospital', 'geoPoint': {'lat': 40.33565, 'lon': -75.92687}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Monique Lisa Abner', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}