COVID
Conditions
Keywords
ozone therapy, COVID19
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.
Interventions
OTHERSystemic 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.
Sponsors
Sociedad Española de Ozonoterapia
Javier Hidalgo Tallón
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
With a randomization table, nurses will treat the patients in treatment groups. Each patient will be in individual rooms.
Intervention model description
Control group with WHO recommended treatment. Treatment group with WHO recommended treatment + systemic ozone therapy.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| COVID19 clinical scale | through study completion, an average of 3 weeks | World Health Organization (WHO) recommended COVID19 clinical scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Venous gas blood analysis | through study completion, an average of 3 weeks | Venous gas blood analysis |
| 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 |
Countries
Spain
Contacts
Primary ContactJose Baeza Noci, MD, PhD
Backup ContactFrancisco J Hidalgo Tallón, MD, PhD
Outcome results
None listed