Using a hypochlorous acid spray to treat COVID-19 patients

Use of a Hypochlorous Acid Spray Solution in the Treatment of COVID-19 Patients : COVICONTROL Study .

This study is testing if a nasal and mouth spray with hypochlorous acid can help hospitalized and symptomatic COVID-19 patients feel better compared to a placebo.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 400 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Monastir (Academic / other)
• Locations: 1 site (Monastir)
• Trial ID: NCT05862480 on ClinicalTrials.gov

What this trial studies

The COVICONTROL study evaluates the efficacy and safety of a nasal and mouth spray containing hypochlorous acid compared to a placebo in hospitalized and symptomatic outpatients with SARS-CoV-2 infection. This prospective, multicenter, randomized, controlled, double-blind study will be conducted in Tunisia at COVID patient management centers. Patients will receive either the hypochlorous acid spray or placebo every three hours for five days, while their health status will be monitored through follow-up contacts. The study aims to assess symptom progression and treatment outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 years old with positive RT-PCR tests for SARS-CoV-2 and symptomatic COVID-19.

Not a fit: Patients with a history of allergy to hypochlorous acid or those with severe uncontrolled diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for COVID-19 patients, potentially improving recovery times and reducing the severity of symptoms.

How similar studies have performed: While the use of hypochlorous acid in other contexts has been explored, this specific application for COVID-19 treatment is novel and has not been extensively tested.

Eligibility criteria

* Inclusion Criteria :

  * Patients with symptoms of COVID who are over 18 years of age and whose nasal swabs have been positive for SARS-CoV-2 based on RT-PCR testing less than 3 days .
  * Patients must have the ability to understand and be willing to sign a written informed consent document from the patient or legal representative.
  * The patient must be able and willing to comply with the requirements of this study protocol.
* Exclusion Criteria:

  1. History of allergy to hypochlorous acid solution .
  2. Oral lesions contraindicating the use of hypochlorous acid solution.
  3. Patients receiving any other investigational agent in a clinical trial.
  4. Intubated patient on mechanical ventilation or with uncontrolled disease : congestive heart failure, IDM, uncontrolled epilepsy or psychiatric illness.
  5. Uncertain patient follow-up during the study.

Where this trial is running

Monastir

• Semir Nouira — Monastir, Tunisia (Recruiting)

Study contacts

• Principal investigator: Semir Nouira, MD — University Hospital Fattouma Bourguiba Monastir , Emergency Department .
• Study coordinator: Semir Nouira, MD

Conditions SARS CoV 2 Infection