The objective is To evaluate the efficacy and safety of nasal spray and mouth sprayapplication with hypochlorous acid-containing solution versus placebo as a curativetreatment for hospitalized SARS-CoV-2 positive patients And for symptomatic SARS-CoV-2positive 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.
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
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.
- 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.
Semir Nouira
Monastir, Tunisia
Investigator: Semir Nouira, MD
Contact: 73106000
semir.nouira.urg@gmail.com
Semir Nouira, MD
73106000 - 216
semir.nouira.urg@gmail.com
Semir Nouira, MD, Principal Investigator
University Hospital Fattouma Bourguiba Monastir , Emergency Department .