Summary
A study is being conducted to assess the effectiveness and safety of a hypochlorous acid spray for treating COVID-19 patients, comparing it to a placebo treatment.
Key points
- Study evaluates hypochlorous acid spray for COVID-19 treatment.
- Conducted in Tunisia with 400 participants.
- Randomized, controlled, double-blind design.
- Primary goal: assess change in viral load after 3 days.
- Secondary goals: symptom duration, hospitalization needs, and contamination rates.
- Participants must be 18+, symptomatic, and test positive for SARS-CoV-2.
- Excludes those with allergies to hypochlorous acid or severe health issues.
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).
Study Design
Resource links provided by the National Library of Medicine
MedlinePlus (opens in a new tab) related topics: COVID-19 (Coronavirus Disease 2019) (opens in a new tab)
Drug Information (opens in a new tab) available for: Hypochlorous acid (opens in a new tab)
U.S. FDA Resources (opens in a new tab)
Arms and Interventions
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. (opens in a new tab)
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:
- 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. 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
Locations
Sponsors and Collaborators
University of Monastir
Investigators
More Information
Additional relevant MeSH terms: