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

Phase 3

• Conditions: COVID
• Interventions: Other: Systemic indirect endovenous ozone therapy

• Registration Number: NCT04359303
• Lead Sponsor: Javier Hidalgo Tallón

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.

Study Timeline

• Study First Submitted: 2020-04-09
• Study First Submitted QC: 2020-04-20
• Study First Posted: 2020-04-24
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-21
• Last Update Posted: 2020-06-23
• Study Start: 2020-07
• Primary Completion: 2020-11
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
TREATMENT	Systemic indirect endovenous ozone therapy	Base WHO recommended treatment + Systemic indirect endovenous ozone therapy

Primary Outcome Measures

Name	Time	Method
COVID19 clinical scale	through study completion, an average of 3 weeks	World Health Organization (WHO) recommended COVID19 clinical scale

Secondary Outcome Measures

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

Trial Locations

Locations (1)

SEOT; 🇪🇸 Valencia, Spain