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Indirect Endovenous Systemic Ozone for New Coronavirus Disease (COVID19) in Non-intubated Patients (OzonoCOVID19)

Primary Purpose

COVID

Status
Unknown status
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
Systemic indirect endovenous ozone therapy
Sponsored by
Javier Hidalgo Tallón
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID focused on measuring ozone therapy, COVID19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • COVID19 virus detected in oro/nasopharynx
  • mild ill according WHO numeric scale
  • mild ill according Berlin criteria
  • non intubated patients
  • signed informed consent

Exclusion Criteria:

  • patients treated with systemic ozone in the last 6 months
  • patients treated before with systemic ozone and referring any side effect
  • glucose-6-phosphate-dehydrogenase deficit
  • other severe concomitant disease apart from COVID19
  • psychiatric disease specified in axis I of l Diagnostic and Statistical Manual of Mental Disorders, 5 edition, but major depression
  • patients not capable of understanding the study methods and targets
  • pregnant woman

Sites / Locations

  • SEOT

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

CONTROL

TREATMENT

Arm Description

Base WHO recommended treatment.

Base WHO recommended treatment + Systemic indirect endovenous ozone therapy

Outcomes

Primary Outcome Measures

COVID19 clinical scale
World Health Organization (WHO) recommended COVID19 clinical scale

Secondary Outcome Measures

Number of died patients
Dead patients during the trial
Oro/nasopharynx virus
Oro/nasopharynx virus
Thorax imaging (0=none; 1=unilateral; 2=bilateral; 3=ground-glass opacification; 4=consolidation)
Thorax imaging according scale. Higher punctuation is worse.
Days in hospital
Days in hospital
Venous gas blood analysis
Venous gas blood analysis

Full Information

First Posted
April 9, 2020
Last Updated
June 21, 2020
Sponsor
Javier Hidalgo Tallón
Collaborators
Sociedad Española de Ozonoterapia
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1. Study Identification

Unique Protocol Identification Number
NCT04359303
Brief Title
Indirect Endovenous Systemic Ozone for New Coronavirus Disease (COVID19) in Non-intubated Patients
Acronym
OzonoCOVID19
Official Title
Randomized Clinical Trial to Evaluate Efficacy and Safety of Systemic Indirect Endovenous Ozone Therapy (SIEVOT) as Adjuvant Treatment in COVID19 Non-intubated Patients
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 2020 (Anticipated)
Primary Completion Date
November 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Javier Hidalgo Tallón
Collaborators
Sociedad Española de Ozonoterapia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Systemic medical ozone has proved to help in several viral diseases, chronic obstructive pulmonary disease and chronic inflammation process. The investigators are sure that its application to COVID-19 patients, as an adjuvant therapy, will improve the health status of these individuals.
Detailed Description
Due to the extreme world situation caused by COVID19 pandemic, the investigators consider unethical not to try any treatment option with a justified rationale. The investigators have explained that medical ozone therapy has a clear scientific basement thanks to all preclinical and clinical investigation already published. It can be classified as chemical stressor that produces a modulation in the redox balance and immunity. Moreover, it is easy and safe to administer with insignificant side effects. The efficacy in viral diseases has been proved in publications together the modulation of interleukin 6 and other proinflammatory cytokines that could potentially help in COVID19 patients. The improve of exchange of gases and microcirculation will surely contribute to enhance this patients' health status. As explained above, the investigators propose to carry out a randomized control trial to evaluate the safety and efficacy of systemic ozone (indirect endovenous) in these patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID
Keywords
ozone therapy, COVID19

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Model Description
Control group with WHO recommended treatment. Treatment group with WHO recommended treatment + systemic ozone therapy.
Masking
ParticipantInvestigator
Masking Description
With a randomization table, nurses will treat the patients in treatment groups. Each patient will be in individual rooms.
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CONTROL
Arm Type
No Intervention
Arm Description
Base WHO recommended treatment.
Arm Title
TREATMENT
Arm Type
Experimental
Arm Description
Base WHO recommended treatment + Systemic indirect endovenous ozone therapy
Intervention Type
Other
Intervention Name(s)
Systemic indirect endovenous ozone therapy
Intervention Description
200 mL at 40 mcg/mL of medical ozone / oxygen in 200 mL of patients blood mixed in an homologated device for the procedure.
Primary Outcome Measure Information:
Title
COVID19 clinical scale
Description
World Health Organization (WHO) recommended COVID19 clinical scale
Time Frame
through study completion, an average of 3 weeks
Secondary Outcome Measure Information:
Title
Number of died patients
Description
Dead patients during the trial
Time Frame
through study completion, an average of 3 weeks
Title
Oro/nasopharynx virus
Description
Oro/nasopharynx virus
Time Frame
through study completion, an average of 3 weeks
Title
Thorax imaging (0=none; 1=unilateral; 2=bilateral; 3=ground-glass opacification; 4=consolidation)
Description
Thorax imaging according scale. Higher punctuation is worse.
Time Frame
through study completion, an average of 3 weeks
Title
Days in hospital
Description
Days in hospital
Time Frame
through study completion, an average of 3 weeks
Title
Venous gas blood analysis
Description
Venous gas blood analysis
Time Frame
through study completion, an average of 3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: COVID19 virus detected in oro/nasopharynx mild ill according WHO numeric scale mild ill according Berlin criteria non intubated patients signed informed consent Exclusion Criteria: patients treated with systemic ozone in the last 6 months patients treated before with systemic ozone and referring any side effect glucose-6-phosphate-dehydrogenase deficit other severe concomitant disease apart from COVID19 psychiatric disease specified in axis I of l Diagnostic and Statistical Manual of Mental Disorders, 5 edition, but major depression patients not capable of understanding the study methods and targets pregnant woman
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jose Baeza Noci, MD, PhD
Phone
+34963177800
Email
jose.baeza@uv.es
First Name & Middle Initial & Last Name or Official Title & Degree
Francisco J Hidalgo Tallón, MD, PhD
Email
fjht63@gmail.com
Facility Information:
Facility Name
SEOT
City
Valencia
ZIP/Postal Code
46013
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jose Baeza Noci, MD, PhD
Phone
+34963177800
Email
jose.baeza@uv.es
First Name & Middle Initial & Last Name & Degree
Francisco J Hidalgo Tallón, MD, PhD
Email
fjht63@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
According to hospitals' statements and data protection agreements
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Indirect Endovenous Systemic Ozone for New Coronavirus Disease (COVID19) in Non-intubated Patients

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