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COVIDPhase 3OzonoCOVID19NCT04359303

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

A Phase 3 study testing Systemic indirect endovenous ozone therapy in people with COVID, run by Javier Hidalgo Tallón at 1 site in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
COVID
What is being tested?
Systemic indirect endovenous ozone therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteSpain
Study dates
Jul 2020to Dec 2020
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Jose Baeza Noci, MD, PhD contact

+34963177800

jose.baeza@uv.es

Francisco J Hidalgo Tallón, MD, PhD contact

fjht63@gmail.com

Spain1 site

  • SEOT

    Valencia, 46013

    Jose Baeza Noci, MD, PhD, +34963177800, jose.baeza@uv.es

    Francisco J Hidalgo Tallón, MD, PhD, fjht63@gmail.com

Other trials in Spain

About this study

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

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.

Read the 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.

Conditions
COVID
Being tested
Systemic indirect endovenous ozone therapy
Keywords
ozone therapy, COVID19
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Systemic indirect endovenous ozone therapyOther

    200 mL at 40 mcg/mL of medical ozone / oxygen in 200 mL of patients blood mixed in an homologated device for the procedure.

Study groups in NCT04359303
Study groupRoleWhat they receive
CONTROLNo interventionBase WHO recommended treatment.
TREATMENTExperimentalBase WHO recommended treatment + Systemic indirect endovenous ozone therapy
Receives: Other: Systemic indirect endovenous ozone therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. COVID19 clinical scale

    World Health Organization (WHO) recommended COVID19 clinical scale

    Measured: through study completion, an average of 3 weeks

Secondary outcomes (5)

  1. Number of died patients

    Dead patients during the trial

    Measured: through study completion, an average of 3 weeks

  2. Oro/nasopharynx virus

    Oro/nasopharynx virus

    Measured: through study completion, an average of 3 weeks

  3. Thorax imaging (0=none; 1=unilateral; 2=bilateral; 3=ground-glass opacification; 4=consolidation)

    Thorax imaging according scale. Higher punctuation is worse.

    Measured: through study completion, an average of 3 weeks

  4. Days in hospital

    Days in hospital

    Measured: through study completion, an average of 3 weeks

  5. Venous gas blood analysis

    Venous gas blood analysis

    Measured: through study completion, an average of 3 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Apr 2020
  2. Study startJul 2020 (estimated)
  3. Primary completionNov 2020 (estimated)
  4. Study completionDec 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Model description
Control group with WHO recommended treatment. Treatment group with WHO recommended treatment + systemic ozone therapy.
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04359303
Sponsor's protocol ID
P.Inv. Ozono-COVID19 Ver.1.2
Acronym
OzonoCOVID19
Status last verified
Jun 2020
First submitted
9 Apr 2020
Last updated
23 Jun 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: According to hospitals' statements and data protection agreements

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.

  • Bocci V, Valacchi G. Nrf2 activation as target to implement therapeutic treatments. Front Chem. 2015 Feb 2;3:4. doi: 10.3389/fchem.2015.00004. eCollection 2015.

    PubMed 25699252

  • Pecorelli A, Bocci V, Acquaviva A, Belmonte G, Gardi C, Virgili F, Ciccoli L, Valacchi G. NRF2 activation is involved in ozonated human serum upregulation of HO-1 in endothelial cells. Toxicol Appl Pharmacol. 2013 Feb 15;267(1):30-40. doi: 10.1016/j.taap.2012.12.001. Epub 2012 Dec 16.

    PubMed 23253326

  • Re L, Martinez-Sanchez G, Bordicchia M, Malcangi G, Pocognoli A, Morales-Segura MA, Rothchild J, Rojas A. Is ozone pre-conditioning effect linked to Nrf2/EpRE activation pathway in vivo? A preliminary result. Eur J Pharmacol. 2014 Nov 5;742:158-62. doi: 10.1016/j.ejphar.2014.08.029. Epub 2014 Sep 16.

    PubMed 25218903

  • Hernandez Rosales FA, Calunga Fernandez JL, Turrent Figueras J, Menendez Cepero S, Montenegro Perdomo A. Ozone therapy effects on biomarkers and lung function in asthma. Arch Med Res. 2005 Sep-Oct;36(5):549-54. doi: 10.1016/j.arcmed.2005.04.021.

    PubMed 16099337

  • Calunga JL, Paz Y, Menendez S, Martinez A, Hernandez A. [Rectal ozone therapy for patients with pulmonary emphysema]. Rev Med Chil. 2011 Apr;139(4):439-47. Epub 2011 Aug 25. Spanish.

    PubMed 21879181

  • 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

  • Vinnik IS, Salmina AB, Tepliakova OV, Drobushevskaia AI, Pozhilenkova EA, Morgun AV, Shapran MV, Kovalenko AO. [The results of combined ozone therapy using in complex treatment of soft tissues infections in patients with diabetes mellitus type II]. Khirurgiia (Mosk). 2015;(2):63-69. doi: 10.17116/hirurgia2015263-69. Russian.

    PubMed 26031822

  • Delgado-Roche L, Riera-Romo M, Mesta F, Hernandez-Matos Y, Barrios JM, Martinez-Sanchez G, Al-Dalaien SM. Medical ozone promotes Nrf2 phosphorylation reducing oxidative stress and pro-inflammatory cytokines in multiple sclerosis patients. Eur J Pharmacol. 2017 Sep 15;811:148-154. doi: 10.1016/j.ejphar.2017.06.017. Epub 2017 Jun 13.

    PubMed 28623000

  • Niu T, Lv C, Yi G, Tang H, Gong C, Niu S. Therapeutic Effect of Medical Ozone on Lumbar Disc Herniation. Med Sci Monit. 2018 Apr 3;24:1962-1969. doi: 10.12659/msm.903243.

    PubMed 29611536

  • Bocci V. Ozonization of blood for the therapy of viral diseases and immunodeficiencies. A hypothesis. Med Hypotheses. 1992 Sep;39(1):30-4. doi: 10.1016/0306-9877(92)90136-z.

    PubMed 1435389

  • Bocci V. Does ozone therapy normalize the cellular redox balance? Implications for therapy of human immunodeficiency virus infection and several other diseases. Med Hypotheses. 1996 Feb;46(2):150-4. doi: 10.1016/s0306-9877(96)90016-x.

    PubMed 8692040

  • Bassi P, Sbrascini S, Mattassi R, D'Angelo F, Franchina A. [Ozone in the treatment of herpes zoster]. Riv Neurobiol. 1982 Jul-Dec;28(3-4):328-33. No abstract available. Italian.

    PubMed 7187109

  • Gierek-Lapinska A, Antoszewski Z, Myga B, Skowron J. [Preliminary report on using therapeutic ozone in infectious conjunctivitis and keratitis and in corneal degeneration]. Klin Oczna. 1992 May-Jun;94(5-6):137-8. Polish.

    PubMed 1453672

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Systemic indirect endovenous ozone therapy in people with COVID, run by Javier Hidalgo Tallón at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 23 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jose Baeza Noci, MD, PhD (+34963177800, jose.baeza@uv.es), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

COVID19 clinical scale (time frame: through study completion, an average of 3 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04359303, which also lists 25 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2020.

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