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

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

Study Overview

• Status: Recruiting
• Conditions: SARS CoV 2 Infection
• Intervention / Treatment: Other: Spray with Placebo Group; Other: Spray with Hypochlorous Acid Group

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Semir Nouira, MD; Phone Number: 216 73106000; Email: semir.nouira.urg@gmail.com

Study Locations

• Tunisia
  • Monastir, Tunisia, 5000
    • Recruiting
    • Semir Nouira
    • Contact: Semir Nouira, MD; Phone Number: 216 73106000; Email: semir.nouira.urg@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Hypochlorous Acid Group (HClO); Patients received one nasal spray in each nasal nostril/3 hours and two oral sprays/3 hours by a solution of hypochlorous acid (NEED DEFENDER) for 5 days	Other: Spray with Placebo Group; For Each Patient included , A prescription of an identical to the intervention nasal spray in each nostril/3 hours and two oral sprays/3 hours by Placebo for 5 days.
Placebo Comparator: Placebo Group; Patients received one nasal spray in each nasal nostril/3 hours and two oral sprays/3 hours by a Placebo for 5 days .	Other: Spray with Hypochlorous Acid Group; For Each Patient included . A prescription of a nasal spray in each nostril/3 hours and two oral sprays/3 hours by a solution of hypochlorous acid (NEED DEFENDER) for 5 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the change in viral load	The primary endpoint in all included patients (outpatients and inpatients ) is the change in viral load between Day 1 and Day 3	3 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Death	Death	30 days
Contamination	For ambulatory patients, the secondary endpoint also includes the percentage of surrounding contamination considered on the basis of the clinic and biological confirmation if necessary.	30 days
Duration of symptoms	Evolution of symptoms : duration of symptoms , appearance and disappearance of symptoms .	30 days
Hospitalization Need for hospitalization.	Need for hospitalization and length of hospitalization	30 days
Need for intensive care.	Need for ICU	30 days
Need for ventilatory support	(CPAP, NIV, Optiflow, MV), and duration of ventilatory support	30 days

Collaborators and Investigators

• Sponsor: University of Monastir
• Investigators: Principal Investigator: Semir Nouira, MD, University Hospital Fattouma Bourguiba Monastir , Emergency Department .

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2023
• Primary Completion (Estimated): September 1, 2023
• Study Completion (Estimated): September 1, 2023

Study Registration Dates

• First Submitted: May 12, 2023
• First Submitted That Met QC Criteria: May 16, 2023
• First Posted (Actual): May 17, 2023

Study Record Updates

• Last Update Posted (Actual): June 26, 2023
• Last Update Submitted That Met QC Criteria: June 23, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: Monastir URG

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No