Efficacy and Safety of Ozonised Oil (HOO) in COVID-19 Patients

NCT04651387 | Withdrawn

• 1 other identifier: DEP_052020
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The anti-viral efficacy of ozone against RNA viruses is already established. Ozone gas have been already proposed as possible therapy for Covid-19 infection with insofar limited success. The development of ozonized oil (HOO) solved this problems making ozone highly stable and bioavailable due to its bound with the lipid carrier. HOO administration is totally noninvasive occurring by oral administration of pills or as nasal spray. HOO regimen could be proposed as complimentary therapeutic treatment for Covid-19 infection, without the need of any modifications of the established standard therapeutic protocols. This complimentary treatment, could be helpful to (a) decrease the severity of the diseases lowering the number of Covid-19 patients requiring high-intensity therapies; (b) fasten qPCR negativization after disease and time-span of hospital recovery. The objective of this study is to investigates the effectiveness of combined use of "HOO capsules" and "HOO oropharyngeal and nasal spray" as a therapeutic supplement in the treatment of patients with confirmed COVID-19, who are moderately ill.

Conditions

SARS-CoV Infection

Keywords

ozone therapy, decrease of viral load of SARS-CoV-2

Outcome Measures

Primary Outcomes (1)

• Viral load of SARS-CoV-2

  The study is aimed at defining if HOO therapy decreases the viral load of SARS-CoV-2 at day 7.

  up to one week

Secondary Outcomes (7)

• The temporal profile of viral load of SARS-CoV-2

  up to four weeks

• The proportion of patients with virological clearance

  up to four weeks

• SaO2

  up to four weeks

• hospitalization stay

  through study completion, an average of 3 months

• Intensive care

  through study completion, an average of 3 months

Study Arms (2)

Intervention group

EXPERIMENTAL

In addition to the routine standard treatments for COVID-19, in the intervention group, combined use of "HOO capsules" and "HOO oropharyngeal and nasal spray" will be administered

Dietary Supplement: Ozonized oil (HOO

Control group

NO INTERVENTION

For the control group, the placebo will be not considered and they will follow the routine standard treatments for COVID-19.

Interventions

Ozonized oil (HOO DIETARY_SUPPLEMENT

In addition to the routine standard treatments for COVID-19, in the intervention group, combined use of "HOO capsules" and "HOO oropharyngeal and nasal spray" will be administered 3 times per day (after breakfast, lunch, dinner, possibly with a delay of one hour from the routine treatment) and will be prescribed for 2 weeks (14 days). Posology: 3 HOO capsules plus 3 HOO intranasal administrations for each naris plus 3 HOO oropharyngeal administrations.

Intervention group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Real time PCR-approved positive COVID-19 test (nasopharyngeal swabs).
• Both gender
• Age between 18 and 80 years
• Lack of participation in other clinical trials
• COVID-19 Severity Score ≤ 5
• Hospitalized ≤48 hours.
• Signing informed consent and willingness of the participant to accept randomization to any assigned treatment

You may not qualify if:

• Pregnancy and breastfeeding.
• BMI ≥35 kg/m2
• Severe and critical COVID-19 pneumonia (COVID-19 Severity Score \> 5)
• Patient connected to the ventilator
• SaO2 less than 80%
• Having liver failure, chronic hepatitis, cirrhosis, and cholestatic liver diseases
• Any severe medical condition with a prognosis of \< 6 months
• Alcohol and drug abuse (during the last 30 days)
• History of known allergy to peanuts

Sponsors & Collaborators

• Neuromed IRCCS: lead

MeSH Terms

Conditions

Severe Acute Respiratory Syndrome

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Licia Iacoviello, MD, PhD

  IRCCS Neuromed

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 1, 2020
• First Posted: December 3, 2020
• Study Start: July 1, 2021
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: January 26, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share