NCT05862480

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 12, 2023

Completed
3 days until next milestone

Study Start

First participant enrolled

May 15, 2023

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 17, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
Last Updated

June 26, 2023

Status Verified

June 1, 2023

Enrollment Period

4 months

First QC Date

May 12, 2023

Last Update Submit

June 23, 2023

Conditions

SARS CoV 2 Infection

Outcome Measures

Primary Outcomes (1)

  • 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

    3 days

Secondary Outcomes (6)

  • Duration of symptoms

    30 days

  • Hospitalization Need for hospitalization.

    30 days

  • Need for intensive care.

    30 days

  • Need for ventilatory support

    30 days

  • Contamination

    30 days

  • +1 more secondary outcomes

Study Arms (2)

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

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 .

Other: Spray with Hypochlorous Acid Group

Interventions

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

Placebo Group
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.

Hypochlorous Acid Group (HClO)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Semir Nouira

Monastir, 5000, Tunisia

RECRUITING

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Semir Nouira, MD

    University Hospital Fattouma Bourguiba Monastir , Emergency Department .

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Semir Nouira, MD

CONTACT

73106000semir.nouira.urg@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Pr Semir Nouira , Head of Emergency department , Fattouma Bourguiba Hospital

Study Record Dates

First Submitted

May 12, 2023

First Posted

May 17, 2023

Study Start

May 15, 2023

Primary Completion

September 1, 2023

Study Completion

September 1, 2023

Last Updated

June 26, 2023

Record last verified: 2023-06

Locations

TU(1)