An interventional study of Spray with Hypochlorous Acid Group and Spray with Placebo Group in SARS CoV 2 Infection, sponsored by University of Monastir. Recruiting at 1 site in Tunisia. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-06-26.
Sponsored by University of Monastir · Not applicable, Interventional, and Treatment
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
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.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's planned enrollment of 400 is above the median of 100 across 4,099 interventional studies indexed under COVID-19.
Browse COVID-19 studies →University of Monastir is the lead sponsor of 112 studies on the registry; 30 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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 .
History of allergy to hypochlorous acid solution .
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
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
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.
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
Time frame: 3 days
Duration of symptoms
Evolution of symptoms : duration of symptoms , appearance and disappearance of symptoms .
Time frame: 30 days
Hospitalization Need for hospitalization.
Need for hospitalization and length of hospitalization
Time frame: 30 days
Need for intensive care.
Need for ICU
Time frame: 30 days
Need for ventilatory support
(CPAP, NIV, Optiflow, MV), and duration of ventilatory support
Time frame: 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.
Time frame: 30 days
Death
Death
Time frame: 30 days
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