Clinical trial NCT05862480: Use of a Hypochlorous Acid Spray Solution in the Treatment of COVID-19 Patients : COVICONTROL Study .
Official title: Use of a Hypochlorous Acid Spray Solution in the Treatment of COVID-19 Patients : COVICONTROL Study .
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: SARS CoV 2 Infection
Lead sponsor: University of Monastir
Sponsor class: OTHER
First posted: 2023-05-17
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: the change in viral load
timeFrame: 3 days
Secondary outcomes:
measure: Duration of symptoms
timeFrame: 30 days
measure: Hospitalization Need for hospitalization.
timeFrame: 30 days
measure: Need for intensive care.
timeFrame: 30 days
measure: Need for ventilatory support
timeFrame: 30 days
measure: Contamination
timeFrame: 30 days
measure: Death
timeFrame: 30 days
Other outcomes:
Locations:
city: Monastir
country: Tunisia
facility: Semir Nouira
Study officials:
affiliation: University Hospital Fattouma Bourguiba Monastir , Emergency Department .
name: Semir Nouira, MD
role: PRINCIPAL_INVESTIGATOR
References: