SARS CoV 2 Infection
Conditions
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.
Interventions
OTHERSpray 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
OTHERSpray 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.
Sponsors
University of Monastir
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Hospitalization Need for hospitalization. | 30 days | Need for hospitalization and length of hospitalization |
| Need for intensive care. | 30 days | Need for ICU |
| Duration of symptoms | 30 days | Evolution of symptoms : duration of symptoms , appearance and disappearance of symptoms . |
| 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. |
| Death | 30 days | Death |
| Need for ventilatory support | 30 days | (CPAP, NIV, Optiflow, MV), and duration of ventilatory support |
Countries
Tunisia
Contacts
Primary ContactSemir Nouira, MD
Outcome results
None listed