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

• Sponsor: University of Monastir (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05862480
• Collaborator: (none)
• Enrollment: 400
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 3.6
• Patients Per Site Per Month: 111.7

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
SARS CoV 2 Infection	Other: Spray with Hypochlorous Acid Group; Other: Spray with Placebo Group	N/A

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).

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 400 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: 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) for 5 days or by a placebo. None of the treating physician or nurses are aware about the nature of medication receive.
• Primary Purpose: Treatment
• Official Title: Use of a Hypochlorous Acid Spray Solution in the Treatment of COVID-19 Patients : COVICONTROL Study .
• Actual Study Start Date: May 15, 2023
• Anticipated Primary Completion Date: Sep 1, 2023
• Anticipated Study Completion Date: Sep 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. Duration of symptoms [30 days]

2. Need for hospitalization. Need for hospitalization. [30 days]

3. Need for intensive care. [30 days]

4. Need for ventilatory support [30 days]

   (CPAP, NIV, Optiflow, MV), and duration of ventilatory support, survival or death.

5. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

• 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Semir Nouira	Monastir		Tunisia	5000

Sponsors and Collaborators

• University of Monastir

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Pr. Semir Nouira, Pr Semir Nouira , Head of Emergency department , Fattouma Bourguiba Hospital, University of Monastir
• ClinicalTrials.gov Identifier: NCT05862480
• Other Study ID Numbers: Monastir URG
• First Posted: May 17, 2023
• Last Update Posted: May 17, 2023
• Last Verified: May 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: COVID-19

Study Results

No Results Posted as of May 17, 2023