Ignite Creation Date:
2024-05-06 @ 3:30 PM
Last Modification Date:
2025-12-16 @ 10:59 PM
Study NCT ID:
NCT04651387
Status:
None
Last Update Posted:
2022-01-26 00:00:00
First Post:
2020-12-01 00:00:00
Brief Title:
Efficacy and Safety of Ozonised Oil (HOO) in COVID-19 Patients
Sponsor:
Neuromed IRCCS
Organization:
Neuromed IRCCS
Study Overview
Official Title:
Efficacy and Safety of Ozonised Oil (HOO) as Adjuvant Nutrition Supplement in COVID-19 Patients With Mild-to-Moderate Disease - HOO-COVID Project
Status:
None
Status Verified Date:
2022-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
No Patients enrolled
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HOO-COVID
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. Indeed, in this form, ozone is extremely volatile and its beneficial effects are only transient. Furthermore, in these studies ozone was administered by auto-hemo-transfusion, an invasive approach that cannot be pursued for preventive purposes in healthy subjects or in severely affected patients. 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.
A challenge test was developed to identify new strategies to prevent Covid-19 infection. Sensitive cells expressing the ACE2 receptor were challenged with oro-pharyngeal containing high viral loads of Covid-19 and the amount of viral RNA able to penetrate inside the cells quantified by qPCR. The ability to inhibit viral infection by UV radiation, hydrogen peroxide, anti-spike Covid-19 antibodies and HOO was comparatively evaluated. The only agent able to fully neutralize Covid-19 was HOO.
The HOO efficacy in preventing finding is due to (a) the high sensitivity of Covid-19 to oxidative stress; (b) the high lipophilicity of Covid-19 and the wide exposure of its lipid envelope for the interaction with lipohilic HOO; (c) the sensitivity of Covid-19 spike proteins to oxidative stress induced by HOO due to their high abundancy of neutrophilic sulphur-rich sites; (d) the HOO capacity to penetrate inside the cells arresting Covid-19 intra-cellular assembly; (e) HOO anti-inflammatory properties causing inhibition of pulmonary macrophage activation, thromboxane release and consequent pulmonary thrombo-embolism, a severe complication occurring in Covid-19 patients; (f) the increased oxygen availability in lung parenchyma.
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.
This study is conducted as an open-label, prospective, controlled, multi-center randomized clinical trial on 74 COVID-19 patients (both sex , aged 18-80 years).
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 and will be prescribed for 2 weeks (14 days). For the control group, the placebo will be not considered and they will follow the routine standard treatments for COVID-19.
The study is aimed at defining if HOO therapy decreases the viral load of SARS-CoV-2 (main outcome). Additionally, secondary objectives will be the assessment of the temporal profile of viral load, the proportion of patients with virological clearance, the hospitalization duration stay, intensive care admission and time to, the COVID-19 Severity and in-hospital mortality.
A challenge test was developed to identify new strategies to prevent Covid-19 infection. Sensitive cells expressing the ACE2 receptor were challenged with oro-pharyngeal containing high viral loads of Covid-19 and the amount of viral RNA able to penetrate inside the cells quantified by qPCR. The ability to inhibit viral infection by UV radiation, hydrogen peroxide, anti-spike Covid-19 antibodies and HOO was comparatively evaluated. The only agent able to fully neutralize Covid-19 was HOO.
The HOO efficacy in preventing finding is due to (a) the high sensitivity of Covid-19 to oxidative stress; (b) the high lipophilicity of Covid-19 and the wide exposure of its lipid envelope for the interaction with lipohilic HOO; (c) the sensitivity of Covid-19 spike proteins to oxidative stress induced by HOO due to their high abundancy of neutrophilic sulphur-rich sites; (d) the HOO capacity to penetrate inside the cells arresting Covid-19 intra-cellular assembly; (e) HOO anti-inflammatory properties causing inhibition of pulmonary macrophage activation, thromboxane release and consequent pulmonary thrombo-embolism, a severe complication occurring in Covid-19 patients; (f) the increased oxygen availability in lung parenchyma.
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.
This study is conducted as an open-label, prospective, controlled, multi-center randomized clinical trial on 74 COVID-19 patients (both sex , aged 18-80 years).
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 and will be prescribed for 2 weeks (14 days). For the control group, the placebo will be not considered and they will follow the routine standard treatments for COVID-19.
The study is aimed at defining if HOO therapy decreases the viral load of SARS-CoV-2 (main outcome). Additionally, secondary objectives will be the assessment of the temporal profile of viral load, the proportion of patients with virological clearance, the hospitalization duration stay, intensive care admission and time to, the COVID-19 Severity and in-hospital mortality.
Detailed Description:
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 Indeed in this form ozone is extremely volatile and its beneficial effects are only transient Furthermore in these studies ozone was administered by auto-hemo-transfusion an invasive approach that cannot be pursued for preventive purposes in healthy subjects or in severely affected patients 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
A challenge test was developed to identify new strategies to prevent Covid-19 infection Sensitive cells expressing the ACE2 receptor were challenged with oro-pharyngeal containing high viral loads of Covid-19 and the amount of viral RNA able to penetrate inside the cells quantified by qPCR The ability to inhibit viral infection by UV radiation hydrogen peroxide anti-spike Covid-19 antibodies and HOO was comparatively evaluated The only agent able to fully neutralize Covid-19 was HOO
The HOO efficacy in preventing finding is due to a the high sensitivity of Covid-19 to oxidative stress b the high lipophilicity of Covid-19 and the wide exposure of its lipid envelope for the interaction with lipohilic HOO c the sensitivity of Covid-19 spike proteins to oxidative stress induced by HOO due to their high abundancy of neutrophilic sulphur-rich sites d the HOO capacity to penetrate inside the cells arresting Covid-19 intra-cellular assembly e HOO anti-inflammatory properties causing inhibition of pulmonary macrophage activation thromboxane release and consequent pulmonary thrombo-embolism a severe complication occurring in Covid-19 patients f the increased oxygen availability in lung parenchyma
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
This study is conducted as an open-label prospective controlled multi-center randomized clinical trial on 74 COVID-19 patients both sex aged 18-80 years
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 and will be prescribed for 2 weeks 14 days For the control group the placebo will be not considered and they will follow the routine standard treatments for COVID-19
The study is aimed at defining if HOO therapy decreases the viral load of SARS-CoV-2 main outcome Additionally secondary objectives will be the assessment of the temporal profile of viral load the proportion of patients with virological clearance the hospitalization duration stay intensive care admission and time to the COVID-19 Severity and in-hospital mortality
A challenge test was developed to identify new strategies to prevent Covid-19 infection Sensitive cells expressing the ACE2 receptor were challenged with oro-pharyngeal containing high viral loads of Covid-19 and the amount of viral RNA able to penetrate inside the cells quantified by qPCR The ability to inhibit viral infection by UV radiation hydrogen peroxide anti-spike Covid-19 antibodies and HOO was comparatively evaluated The only agent able to fully neutralize Covid-19 was HOO
The HOO efficacy in preventing finding is due to a the high sensitivity of Covid-19 to oxidative stress b the high lipophilicity of Covid-19 and the wide exposure of its lipid envelope for the interaction with lipohilic HOO c the sensitivity of Covid-19 spike proteins to oxidative stress induced by HOO due to their high abundancy of neutrophilic sulphur-rich sites d the HOO capacity to penetrate inside the cells arresting Covid-19 intra-cellular assembly e HOO anti-inflammatory properties causing inhibition of pulmonary macrophage activation thromboxane release and consequent pulmonary thrombo-embolism a severe complication occurring in Covid-19 patients f the increased oxygen availability in lung parenchyma
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
This study is conducted as an open-label prospective controlled multi-center randomized clinical trial on 74 COVID-19 patients both sex aged 18-80 years
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 and will be prescribed for 2 weeks 14 days For the control group the placebo will be not considered and they will follow the routine standard treatments for COVID-19
The study is aimed at defining if HOO therapy decreases the viral load of SARS-CoV-2 main outcome Additionally secondary objectives will be the assessment of the temporal profile of viral load the proportion of patients with virological clearance the hospitalization duration stay intensive care admission and time to the COVID-19 Severity and in-hospital mortality
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None