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

July 15, 2023 updated by: Monique Lisa Abner

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Actual)

88

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Reading, Pennsylvania, United States, 19610
        • Tower Health/Reading Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

The source of enrollees was generated from persons presenting to one ambulatory testing facility for nasopharyngeal swab testing for COVID-19.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction in symptoms of COVID-19
Time Frame: 40 days from start of nasal lavage
Change in sense of smell, fever profile, nasal congestion, and headache
40 days from start of nasal lavage

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Monique Lisa Abner

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 24, 2020

Primary Completion (Actual)

March 13, 2021

Study Completion (Actual)

April 13, 2021

Study Registration Dates

First Submitted

July 15, 2023

First Submitted That Met QC Criteria

July 15, 2023

First Posted (Actual)

July 18, 2023

Study Record Updates

Last Update Posted (Actual)

July 18, 2023

Last Update Submitted That Met QC Criteria

July 15, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB 036-020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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