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

NCT04359303 | Unknown Phase 3 DMC

• 1 other identifier: P.Inv. Ozono-COVID19 Ver.1.2
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID

Keywords

ozone therapy; COVID19

Outcome Measures

Primary Outcomes (1)

• COVID19 clinical scale

  World Health Organization (WHO) recommended COVID19 clinical scale

  through study completion, an average of 3 weeks

Secondary Outcomes (5)

• Number of died patients

  through study completion, an average of 3 weeks

• Oro/nasopharynx virus

  through study completion, an average of 3 weeks

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

  through study completion, an average of 3 weeks

• Days in hospital

  through study completion, an average of 3 weeks

• Venous gas blood analysis

  through study completion, an average of 3 weeks

Study Arms (2)

CONTROL

NO INTERVENTION

Base WHO recommended treatment.

TREATMENT

EXPERIMENTAL

Base WHO recommended treatment + Systemic indirect endovenous ozone therapy

Other: Systemic indirect endovenous ozone therapy

Interventions

Systemic indirect endovenous ozone therapy OTHER

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

TREATMENT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Javier Hidalgo Tallón: lead
• Sociedad Española de Ozonoterapia: collaborator

Study Sites (1)

SEOT

Valencia, 46013, Spain

Location

Related Publications (25)

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

  BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 25699252 BACKGROUND

• 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.

  PMID: 23253326 BACKGROUND

• 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.

  PMID: 25218903 BACKGROUND

• 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.

  PMID: 16099337 BACKGROUND

• 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.

  PMID: 21879181 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 26031822 BACKGROUND

• 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.

  PMID: 28623000 BACKGROUND

• 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.

  PMID: 29611536 BACKGROUND

• 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.

  PMID: 1435389 BACKGROUND

• 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.

  PMID: 8692040 BACKGROUND

• 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.

  PMID: 7187109 BACKGROUND

• 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.

  PMID: 1453672 BACKGROUND

• 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.

  PMID: 17057311 BACKGROUND

• 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.

  PMID: 29559601 BACKGROUND

• 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.

  PMID: 19544653 BACKGROUND

• 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.

  PMID: 18655281 BACKGROUND

• 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.

  PMID: 20017375 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 21417811 BACKGROUND

• 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

  BACKGROUND

• Ibrahim AM, Elkot RA, Khashaba SA. Successful Treatment of Multiple Common Warts With Intralesional Ozone. Dermatol Surg. 2020 Jul;46(7):928-933. doi: 10.1097/DSS.0000000000002174.

  PMID: 31584525 BACKGROUND

• 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

  BACKGROUND

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Jose Baeza Noci, MD, PhD

CONTACT

+34963177800; jose.baeza@uv.es

Francisco J Hidalgo Tallón, MD, PhD

CONTACT

fjht63@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: With a randomization table, nurses will treat the patients in treatment groups. Each patient will be in individual rooms.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer

Model Details: Control group with WHO recommended treatment. Treatment group with WHO recommended treatment + systemic ozone therapy.

Study Record Dates

• First Submitted: April 9, 2020
• First Posted: April 24, 2020
• Study Start: July 1, 2020
• Primary Completion: November 1, 2020
• Study Completion: December 1, 2020
• Last Updated: June 23, 2020

Record last verified: 2020-06

Locations

ES (1)