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

COVID Clinical Trial

— 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04359303
• Other study ID #: P.Inv. Ozono-COVID19 Ver.1.2
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: July 2020
• Est. completion date: December 2020

Study information

• Verified date: June 2020
• Source: Universidad Católica San Antonio de Murcia
• Contact: Jose Baeza Noci, MD, PhD
• Phone: +34963177800
• Email: jose.baeza[@]uv.es
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: December 2020
• Est. primary completion date: November 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID

Intervention

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.

Locations

Country	Name	City	State
Spain	SEOT	Valencia

Sponsors (2)

Lead Sponsor	Collaborator
Javier Hidalgo Tallón	Sociedad Española de Ozonoterapia

Country where clinical trial is conducted

Spain, 

References & Publications (25)

Baeza J, Cabo JR, Gómez M, et al. WFOTs Review on Evidence Based Ozone Therapy. World Federation of Ozone Therapy. Brescia: WFOT; 2015.

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. Italian. — View Citation

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. Review. — View Citation

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. — View Citation

Bocci V. Ozone: A new medical drug. Netherlands: Springer; 2011.

Bocci V. Ozonization of blood for the therapy of viral diseases and immunodeficiencies. A hypothesis. Med Hypotheses. 1992 Sep;39(1):30-4. — View Citation

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

Calunga JL, Paz Y, Menéndez S, Martínez A, Hernández A. [Rectal ozone therapy for patients with pulmonary emphysema]. Rev Med Chil. 2011 Apr;139(4):439-47. doi: /S0034-98872011000400004. Epub 2011 Aug 25. Spanish. — View Citation

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

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

Chernyshev AL, Filimonov RM, Karasev AV, Neronov VA, Maksimov VA. [Combined treatment including ozonotherapy of patients with viral hepatitis ]. Vopr Kurortol Fizioter Lech Fiz Kult. 2008 May-Jun;(3):19-22. Russian. — View Citation

Delgado-Roche L, Riera-Romo M, Mesta F, Hernández-Matos Y, Barrios JM, Martínez-Sánchez 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. — View Citation

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. — View Citation

Hernández Rosales FA, Calunga Fernández JL, Turrent Figueras J, Menéndez 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. — View Citation

Huang J, Huang J, Xiang Y, Gao L, Pan Y, Lu J. [Topical ozone therapy: An innovative solution to patients with herpes zoster]. Zhong Nan Da Xue Xue Bao Yi Xue Ban. 2018 Feb 28;43(2):168-172. doi: 10.11817/j.issn.1672-7347.2018.02.011. Chinese. — View Citation

Ibrahim AM, Elkot RA, Khashaba SA. Successful Treatment of Multiple Common Warts With Intralesional Ozone. Dermatol Surg. 2019 Oct 1. doi: 10.1097/DSS.0000000000002174. [Epub ahead of print] — View Citation

Jiao XJ, Peng X. [Clinilal study of medical ozone therapy in chronic hepatitis B of 20 patients]. Zhonghua Shi Yan He Lin Chuang Bing Du Xue Za Zhi. 2008 Dec;22(6):484-5. Chinese. — View Citation

Mandzhgaladze NR, Kharebava ER, Didia TsG, Ardzhevanishvili MD, Gudzhabidze MV, Chigiashvili TsN. [Influence of intravenous ozone treatment on the level of different specificity antibodies]. Georgian Med News. 2006 Sep;(138):93-5. Russian. — View Citation

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

Neronov VA. [Experience with the use of ozone for the treatment of chronic viral hepatitis]. Vopr Kurortol Fizioter Lech Fiz Kult. 2009 Nov-Dec;(6):14-7. Russian. — View Citation

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. — View Citation

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. — View Citation

Re L, Martínez-Sánchez 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. — View Citation

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. — View Citation

Zaky S, Kamel SE, Hassan MS, Sallam NA, Shahata MA, Helal SR, Mahmoud H. Preliminary results of ozone therapy as a possible treatment for patients with chronic hepatitis C. J Altern Complement Med. 2011 Mar;17(3):259-63. doi: 10.1089/acm.2010.0016. — View Citation

* Note: There are 25 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	COVID19 clinical scale	World Health Organization (WHO) recommended COVID19 clinical scale	through study completion, an average of 3 weeks
Secondary	Number of died patients	Dead patients during the trial	through study completion, an average of 3 weeks
Secondary	Oro/nasopharynx virus	Oro/nasopharynx virus	through study completion, an average of 3 weeks
Secondary	Thorax imaging (0=none; 1=unilateral; 2=bilateral; 3=ground-glass opacification; 4=consolidation)	Thorax imaging according scale. Higher punctuation is worse.	through study completion, an average of 3 weeks
Secondary	Days in hospital	Days in hospital	through study completion, an average of 3 weeks
Secondary	Venous gas blood analysis	Venous gas blood analysis	through study completion, an average of 3 weeks