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

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ClinicalTrials.gov Identifier: NCT04359303
Recruitment Status : Not yet recruiting
First Posted : April 24, 2020
Last Update Posted : June 23, 2020
Sponsor:
Collaborator:
Sociedad Española de Ozonoterapia
Information provided by (Responsible Party):
Javier Hidalgo Tallón, Universidad Católica San Antonio de Murcia

Study Description
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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.

Condition or disease Intervention/treatment Phase
COVID Other: Systemic indirect endovenous ozone therapy Phase 3

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Control group with WHO recommended treatment. Treatment group with WHO recommended treatment + systemic ozone therapy.
Masking: Double (Participant, Investigator)
Masking Description: With a randomization table, nurses will treat the patients in treatment groups. Each patient will be in individual rooms.
Primary Purpose: Treatment
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
Estimated Study Start Date : July 2020
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ozone

Arms and Interventions
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Arm Intervention/treatment
No Intervention: CONTROL
Base WHO recommended treatment.
Experimental: TREATMENT
Base WHO recommended treatment + Systemic indirect endovenous ozone therapy
 Other: Systemic indirect endovenous ozone therapy
200 mL at 40 mcg/mL of medical ozone / oxygen in 200 mL of patients blood mixed in an homologated device for the procedure.


Outcome Measures
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Primary Outcome Measures :
  1. COVID19 clinical scale [ Time Frame: through study completion, an average of 3 weeks ]
    World Health Organization (WHO) recommended COVID19 clinical scale


Secondary Outcome Measures :
  1. Number of died patients [ Time Frame: through study completion, an average of 3 weeks ]
    Dead patients during the trial

  2. Oro/nasopharynx virus [ Time Frame: through study completion, an average of 3 weeks ]
    Oro/nasopharynx virus

  3. Thorax imaging (0=none; 1=unilateral; 2=bilateral; 3=ground-glass opacification; 4=consolidation) [ Time Frame: through study completion, an average of 3 weeks ]
    Thorax imaging according scale. Higher punctuation is worse.

  4. Days in hospital [ Time Frame: through study completion, an average of 3 weeks ]
    Days in hospital

  5. Venous gas blood analysis [ Time Frame: through study completion, an average of 3 weeks ]
    Venous gas blood analysis


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04359303


Contacts
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Contact: Jose Baeza Noci, MD, PhD +34963177800 jose.baeza@uv.es
Contact: Francisco J Hidalgo Tallón, MD, PhD fjht63@gmail.com

Locations
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Spain
SEOT
Valencia, Spain, 46013
Contact: Jose Baeza Noci, MD, PhD    +34963177800    jose.baeza@uv.es   
Contact: Francisco J Hidalgo Tallón, MD, PhD       fjht63@gmail.com   
Sponsors and Collaborators
Javier Hidalgo Tallón
Sociedad Española de Ozonoterapia
More Information
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Publications:
Bocci V. Ozone: A new medical drug. Netherlands: Springer; 2011.
Baeza J, Cabo JR, Gómez M, et al. WFOTs Review on Evidence Based Ozone Therapy. World Federation of Ozone Therapy. Brescia: WFOT; 2015.
Borrelli E, Bocci V. Oxygen Ozone Therapy in the Treatment of Chronic Obstructive Pulmonary Disease: An Integrative Approach. Am J Clin Exp Med. 2014;2(2):9-13. DOI:10.11648/j.ajcem.20140202.11
Cespedes-Suarez J, Martin-Serrano Y, Carballosa-Peña MR, Dager-Carballosa DR . Response of patients with chronic Hepatitis B in one year of treatment with Major Autohemotherapy. J Ozone Ther. 2018:2(3) DOI:10.7203/jo3t.2.3.2018.11459
Mawsouf MN, Tanbouli TT, Viebahn-Hänsler R. Ozone therapy in patients with viral Hepatitis C: Ten Years' Experience. Ozone Sci Eng. 2012;34(6):451-458. DOI:10.1080/01919512.2012.720161
Cespedes-Suarez J, Martin-Serrano Y, Carballosa-Peña MR, Dager-Carballosa DR. The immune response behavior in HIV-AIDS patients treated with Ozone therapy for two years. J Ozone Ther. 2019:2(3). DOI:10.7203/jo3t.2.3.2018.11458

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Responsible Party: Javier Hidalgo Tallón, Lecturer, Universidad Católica San Antonio de Murcia
ClinicalTrials.gov Identifier: NCT04359303    
Other Study ID Numbers: P.Inv. Ozono-COVID19 Ver.1.2
First Posted: April 24, 2020    Key Record Dates
Last Update Posted: June 23, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: According to hospitals' statements and data protection agreements

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Javier Hidalgo Tallón, Universidad Católica San Antonio de Murcia:
ozone therapy
COVID19