Use of a Hypochlorous Acid Spray Solution in the Treatment of COVID-19 Patients : COVICONTROL Study .
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- University of Monastir
- Enrollment
- 400
- Locations
- 2
- Primary Endpoint
- the change in viral load
Study Overview
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 :
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
Exclusion Criteria
- •History of allergy to hypochlorous acid solution .
- •Oral lesions contraindicating the use of hypochlorous acid solution.
- •Patients receiving any other investigational agent in a clinical trial.
- •Intubated patient on mechanical ventilation or with uncontrolled disease : congestive heart failure, IDM, uncontrolled epilepsy or psychiatric illness.
- •Uncertain patient follow-up during the study.
Outcomes
Primary Outcomes
the change in viral load
Time Frame: 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 Outcomes
- Death(30 days)
- Duration of symptoms(30 days)
- Hospitalization Need for hospitalization.(30 days)
- Need for ventilatory support(30 days)
- Contamination(30 days)
- Need for intensive care.(30 days)
Investigators
Pr. Semir Nouira
Pr Semir Nouira , Head of Emergency department , Fattouma Bourguiba Hospital
University of Monastir