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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
50
200 mL at 40 mcg/mL of medical ozone / oxygen in 200 mL of patients blood mixed in an homologated device for the procedure.
SEOT
Valencia, Spain
COVID19 clinical scale
World Health Organization (WHO) recommended COVID19 clinical scale
Time frame: through study completion, an average of 3 weeks
Number of died patients
Dead patients during the trial
Time frame: through study completion, an average of 3 weeks
Oro/nasopharynx virus
Oro/nasopharynx virus
Time frame: through study completion, an average of 3 weeks
Thorax imaging (0=none; 1=unilateral; 2=bilateral; 3=ground-glass opacification; 4=consolidation)
Thorax imaging according scale. Higher punctuation is worse.
Time frame: through study completion, an average of 3 weeks
Days in hospital
Days in hospital
Time frame: through study completion, an average of 3 weeks
Venous gas blood analysis
Venous gas blood analysis
Time frame: through study completion, an average of 3 weeks
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