The COVICONTROL study is a clinical trial evaluating the efficacy and safety of a nasal and mouth spray containing hypochlorous acid in treating hospitalized and symptomatic SARS-CoV-2 positive patients, and is estimated to enroll 400 participants and be completed in September 2023.
- The study aims to evaluate the efficacy and safety of nasal and mouth spray application with hypochlorous acid-containing solution versus placebo as a curative treatment for hospitalized and symptomatic SARS-CoV-2 positive patients. - The COVICONTROL study is a prospective, multicenter, randomized, controlled, double-blind study. - The 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). - The study will enroll 400 participants. - Patients will receive either a spray of solution containing hypochlorous acid or a placebo according to the predetermined randomization. - The primary endpoint in all included patients is the change in viral load between Day 1 and Day 3. - The secondary endpoints include duration of symptoms, need for hospitalization, need for intensive care, need for ventilatory support, and contamination. - 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 are eligible to participate. - Patients must have the ability to understand and be willing to sign a written informed consent document from the patient or legal representative.
This is from clinicaltrials.gov in 2023 at https://clinicaltrials.gov/ct2/show/NCT05862480.
Keywords: COVID-19, hypochlorous acid, clinical trial, SARS-CoV-2, treatment.
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
Condition or disease | Intervention/treatment | Phase |
SARS CoV 2 Infection | Other: Spray with Hypochlorous Acid Group Other: Spray with Placebo Group | Not Applicable |
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).
Study Design
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 400 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Masking Description: | 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) for 5 days or by a placebo. None of the treating physician or nurses are aware about the nature of medication receive. |
Primary Purpose: | Treatment |
Official Title: | Use of a Hypochlorous Acid Spray Solution in the Treatment of COVID-19 Patients : COVICONTROL Study . |
Actual Study Start Date : | May 15, 2023 |
Estimated Primary Completion Date : | September 2023 |
Estimated Study Completion Date : | September 2023 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics: COVID-19 (Coronavirus Disease 2019)
Drug Information available for: Hypochlorous acid
U.S. FDA Resources
Arms and Interventions
Arm | Intervention/treatment |
Active Comparator: Hypochlorous Acid Group (HClO) 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 | 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. |
Placebo Comparator: Placebo Group Patients received one nasal spray in each nasal nostril/3 hours and two oral sprays/3 hours by a Placebo for 5 days . | 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 |
Outcome Measures
Primary Outcome Measures :
- 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 Outcome Measures :
- Duration of symptoms [ Time Frame: 30 days ]
- Need for hospitalization. Need for hospitalization. [ Time Frame: 30 days ]
- Need for intensive care. [ Time Frame: 30 days ]
- Need for ventilatory support [ Time Frame: 30 days ](CPAP, NIV, Optiflow, MV), and duration of ventilatory support, survival or death.
- Contamination [ Time Frame: 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.
Eligibility Criteria
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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.
- 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.
Inclusion Criteria :
Exclusion Criteria:
Contacts and Locations
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05862480
Contacts
Contact: Semir Nouira, MD | 73106000 ext 216 | semir.nouira.urg@gmail.com |
Locations
Tunisia |
Semir Nouira |
Monastir, Tunisia, 5000 |
Contact: Semir Nouira, MD 73106000 ext 216 semir.nouira.urg@gmail.com |
Sponsors and Collaborators
University of Monastir
Investigators
Principal Investigator: | Semir Nouira, MD | University Hospital Fattouma Bourguiba Monastir , Emergency Department . |
More Information
Responsible Party: | Pr. Semir Nouira, Pr Semir Nouira , Head of Emergency department , Fattouma Bourguiba Hospital, University of Monastir |
ClinicalTrials.gov Identifier: | NCT05862480 History of Changes |
Other Study ID Numbers: | Monastir URG |
First Posted: | May 17, 2023 Key Record Dates |
Last Update Posted: | May 17, 2023 |
Last Verified: | May 2023 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms: