Clinical trial NCT05950295: Intranasal Lavage With Hypochlorous Acid Safely Reduces the Symptoms in the Ambulatory Patient With COVID-19.
Official title: Intranasal Lavage With Hypochlorous Acid Safely Reduces the Symptoms in the Ambulatory Patient With COVID-19.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Keywords: intranasal lavage
Lead sponsor: Monique Lisa Abner
Sponsor class: OTHER
First posted: 2023-07-18
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Reduction in symptoms of COVID-19
timeFrame: 40 days from start of nasal lavage
Secondary outcomes:
Other outcomes:
Locations:
city: Reading
country: United States
facility: Tower Health/Reading Hospital
state: Pennsylvania
Study officials:
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