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

Not Applicable

Recruiting

• Conditions: SARS CoV 2 Infection
• Interventions: Other: Spray with Placebo Group; Other: Spray with Hypochlorous Acid Group

• Registration Number: NCT05862480
• Lead Sponsor: University of Monastir

Brief 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

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 Timeline

• Study First Submitted: 2023-05-12
• Study Start: 2023-05-15
• Study First Submitted QC: 2023-05-16
• Study First Posted: 2023-05-17
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-23
• Last Update Posted: 2023-06-26
• Primary Completion: 2023-09
• Study Completion: 2023-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

Not provided

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hypochlorous Acid Group (HClO)	Spray with Placebo Group	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
Placebo Group	Spray with Hypochlorous Acid Group	Patients received one nasal spray in each nasal nostril/3 hours and two oral sprays/3 hours by a Placebo for 5 days .

Primary Outcome Measures

Name	Time	Method
the change in viral load	3 days	The primary endpoint in all included patients (outpatients and inpatients ) is the change in viral load between Day 1 and Day 3

Secondary Outcome Measures

Name	Time	Method
Death	30 days	Death
Duration of symptoms	30 days	Evolution of symptoms : duration of symptoms , appearance and disappearance of symptoms .
Hospitalization Need for hospitalization.	30 days	Need for hospitalization and length of hospitalization
Need for ventilatory support	30 days	(CPAP, NIV, Optiflow, MV), and duration of ventilatory support
Contamination	30 days	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.
Need for intensive care.	30 days	Need for ICU

Trial Locations

Locations (1)

Semir Nouira; 🇹🇳 Monastir, Tunisia