Ignite Creation Date:
2024-05-06 @ 7:00 PM
Last Modification Date:
2024-10-26 @ 2:58 PM
Study NCT ID:
NCT05862480
Status:
RECRUITING
Last Update Posted:
2023-06-26
First Post:
2023-05-12
Brief Title:
Use of a Hypochlorous Acid Spray Solution in the Treatment of COVID-19 Patients COVICONTROL Study
Sponsor:
University of Monastir
Organization:
University of Monastir
Study Overview
Official Title:
Use of a Hypochlorous Acid Spray Solution in the Treatment of COVID-19 Patients COVICONTROL Study
Status:
RECRUITING
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COVICONTROL
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 sprays3 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 PCRAt D10 and D30 data on disease progression will be collected one last time
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 sprays3 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 PCRAt D10 and D30 data on disease progression will be collected one last time
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None