SARS CoV 2 InfectionCOVICONTROLNCT05862480
Use of a Hypochlorous Acid Spray Solution in the Treatment of COVID-19 Patients : COVICONTROL Study .
A study testing Spray with Hypochlorous Acid Group in people with SARS CoV 2 Infection, run by University of Monastir at 1 site in Tunisia.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- SARS CoV 2 Infection
- What is being tested?
- Spray with Hypochlorous Acid Group
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 1 siteTunisia
- Study dates
- 15 May 2023to Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Tunisia1 site, 1 recruiting
- Recruiting
Semir Nouira
Monastir, 5000
Semir Nouira, MD, 73106000 ext. 216, semir.nouira.urg@gmail.com
About this study
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
Read the 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.
- Conditions
- SARS CoV 2 Infection
- Being tested
- Spray with Hypochlorous Acid Group, Spray with Placebo Group
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spray with Hypochlorous Acid GroupOther
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
Spray with Placebo GroupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Hypochlorous Acid Group (HClO) | Active comparator | 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 Receives: Other: Spray with Placebo Group |
| Placebo Group | Placebo comparator | Patients received one nasal spray in each nasal nostril/3 hours and two oral sprays/3 hours by a Placebo for 5 days . Receives: Other: Spray with Hypochlorous Acid Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 days
Secondary outcomes (6)
Duration of symptoms
Evolution of symptoms : duration of symptoms , appearance and disappearance of symptoms .
Measured: 30 days
Hospitalization Need for hospitalization.
Need for hospitalization and length of hospitalization
Measured: 30 days
Need for intensive care.
Need for ICU
Measured: 30 days
Need for ventilatory support
(CPAP, NIV, Optiflow, MV), and duration of ventilatory support
Measured: 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.
Measured: 30 days
Death
Death
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2023
- Study start15 May 2023
- Primary completionSep 2023 (estimated)
- Study completionSep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS CoV 2 InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Monastir
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pr. Semir Nouira, University of Monastir
- Investigators
- Semir Nouira, MD, Principal investigator, University Hospital Fattouma Bourguiba Monastir , Emergency Department .
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05862480
- Sponsor's protocol ID
- Monastir URG
- Acronym
- COVICONTROL
- Status last verified
- Jun 2023
- First submitted
- 12 May 2023
- Last updated
- 26 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of a Hypochlorous Acid Spray Solution in the Treatment of COVID-19 Patients : COVICONTROL Study .
- ClinicalTrials.gov ID
- NCT05862480
- Acronym / sponsor ID
- COVICONTROL / Monastir URG
- Conditions
- SARS CoV 2 Infection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University of MonastirUniversity, hospital or other
- Study start
- 15 May 2023 (actual)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 17 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypochlorous Acid Group (HClO) | Active comparator | Other: Spray with Placebo GroupPatients 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 |
| Placebo Group | Placebo comparator | Other: Spray with Hypochlorous Acid GroupPatients received one nasal spray in each nasal nostril/3 hours and two oral sprays/3 hours by a Placebo for 5 days . |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
Key exclusion criteria (5 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spray with Hypochlorous Acid GroupFor 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 | Placebo Group |
| Spray with Placebo GroupFor 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. | Other | Hypochlorous Acid Group (HClO) |
Primary outcome
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
6 secondary outcomes
Duration of symptoms
Time frame: 30 days
Hospitalization Need for hospitalization.
Time frame: 30 days
Need for intensive care.
Time frame: 30 days
Need for ventilatory support
Time frame: 30 days
Contamination
Time frame: 30 days
Death
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Semir Nouira, MD principal investigator
University Hospital Fattouma Bourguiba Monastir , Emergency Department .
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spray with Hypochlorous Acid Group in people with SARS CoV 2 Infection, run by University of Monastir at 1 site in Tunisia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Semir Nouira, MD (73106000 ext. 216, semir.nouira.urg@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the change in viral load (time frame: 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2023.