Clinical Trial Details
— Status: Withdrawn
Administrative data
NCT number |
NCT04651387 |
Other study ID # |
DEP_052020 |
Secondary ID |
|
Status |
Withdrawn |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
July 2021 |
Est. completion date |
December 2021 |
Study information
Verified date |
January 2022 |
Source |
Neuromed IRCCS |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
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.