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

NCT ID: NCT05862480

Last Updated: 2023-06-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-15
• Study Completion Date: 2023-09-30

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.

Conditions

SARS CoV 2 Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Spray with Placebo Group

Intervention Type: OTHER

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 Group

Patients received one nasal spray in each nasal nostril/3 hours and two oral sprays/3 hours by a Placebo for 5 days .

Group Type: PLACEBO_COMPARATOR

Spray with Hypochlorous Acid Group

Intervention Type: OTHER

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

Interventions

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

Intervention Type: 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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Monastir

OTHER

Sponsor Role: lead

Responsible Party

Pr. Semir Nouira

Pr Semir Nouira , Head of Emergency department , Fattouma Bourguiba Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Semir Nouira, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Fattouma Bourguiba Monastir , Emergency Department .

Locations

Semir Nouira

Monastir, , Tunisia

Site Status: RECRUITING

Countries

Tunisia

Central Contacts

Semir Nouira, MD

Role: CONTACT

semir.nouira.urg@gmail.com

73106000 ext. 216

Facility Contacts

Semir Nouira, MD

Role: primary

semir.nouira.urg@gmail.com

73106000 ext. 216

Other Identifiers

Monastir URG

Identifier Type: -

Identifier Source: org_study_id