Intranasal Lavage With Hypochlorous Acid Safely Reduces the Symptoms in the Ambulatory Patient With COVID-19.

COVID-19 Clinical Trial

Official title:

Intranasal Lavage With Hypochlorous Acid Safely Reduces the Symptoms in the Ambulatory Patient With COVID-19.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05950295
• Other study ID #: IRB 036-020
• Status: Completed
• Start date: September 24, 2020
• Est. completion date: April 13, 2021

Study information

• Verified date: July 2023
• Source: Monique Lisa Abner
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Participants will asked to do the following:

• Irrigate each nostril once a day for ten days with a hypochlorous acid solution.

• Write a daily record of the presence or absence of symptoms such as fever, headache, chills, nausea, or change in sense of smell.

• After ten days, return the daily log in the mail to the investigator.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: April 13, 2021
• Est. primary completion date: March 13, 2021
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All gender aged 18 years and older.

• Positive COVID-19 specific antigen test resulted within 72 hours.

Exclusion Criteria:

• Persons with known current pregnancy

• Persons less than or equal to 17 years of age.

• Persons currently using any intranasal medications or agents

• Persons unwilling to use nasal lavage.

Related Conditions & MeSH terms

• COVID-19

Intervention

Other:
• Intranasal lavage with hypochlorous acid solution
intranasal lavage for ten days

Locations

Country	Name	City	State
United States	Tower Health/Reading Hospital	Reading	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Monique Lisa Abner

Country where clinical trial is conducted

United States, 

References & Publications (12)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Wang G. Chloride flux in phagocytes. Immunol Rev. 2016 Sep;273(1):219-31. doi: 10.1111/imr.12438. — View 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. — View 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.

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in symptoms of COVID-19	Change in sense of smell, fever profile, nasal congestion, and headache	40 days from start of nasal lavage