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

Last updated: June 23, 2023
Sponsor: University of Monastir
Overall Status: Active - Recruiting

Phase

N/A

Condition

Covid-19

Treatment

Spray with Hypochlorous Acid Group

Spray with Placebo Group

Clinical Study ID

NCT05862480
Monastir URG
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The objective is To evaluate the efficacy and safety of nasal spray and mouth spray application with hypochlorous acid-containing solution versus placebo as a curative treatment for hospitalized SARS-CoV-2 positive patients And for symptomatic SARS-CoV-2 positive patients followed as outpatients

Eligibility Criteria

Inclusion

  • Inclusion Criteria :
  • Patients with symptoms of COVID who are over 18 years of age and whose nasalswabs 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 writteninformed consent document from the patient or legal representative.
  • The patient must be able and willing to comply with the requirements of thisstudy protocol.

Exclusion

  • 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.

Study Design

Total Participants: 400
Treatment Group(s): 2
Primary Treatment: Spray with Hypochlorous Acid Group
Phase:
Study Start date:
May 15, 2023
Estimated Completion Date:
September 30, 2023

Study Description

The COVICONTROL study is a prospective, multicenter study . It is a randomized, controlled, double-blind study.

The COVICONTROL study will be conducted in Tunisia at the COVID patient management centers in the emergency departments of Monastir (Fattouma Bourguiba) and Sousse (Hospital Of Sahloul).

After initial medical evaluation, every patient who meet the inclusion criteria, will receive randomly either A spray of solution containing hypochlorous acid or Placebo as detailed above according to the predetermined randomization.

For each patient included, one nasal spray in each nasal nostril /3 hours and two oral sprays/3 hours either by a solution of hypochlorous acid (NEED DEFENDER) or by a placebo. for 5 days None of the treating physician or nurses are aware about the nature of medication receive. In both arms, patients can receive antipyretics, antibacterials, antivirals, antifungals and anti-inflammatories at the discretion of the treating physician.

  • Patients follow-up :

During the study , a research member maintains contact (face-to-face if hospitalized or by telephone if ambulatory) at D2, D3, and D5 with participating patients to ensure compliance with treatment and report on disease progression: disappearance or persistence of symptoms, need for hospitalization, need for intensive care, duration of hospitalization, need for respiratory assistance (CPAP, NIV, Optiflow, VM), duration of respiratory assistance, survival or death.

At day 3 :a nasopharyngeal swab will be taken to check the viral load using quantitative RT PCR.At D10 and D30, data on disease progression will be collected one last time.

Connect with a study center

  • Semir Nouira

    Monastir, 5000
    Tunisia

    Active - Recruiting

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