Indirect Endovenous Systemic Ozone for New Coronavirus Disease (COVID19) in Non-intubated Patients (OzonoCOVID19)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04359303|
Recruitment Status : Not yet recruiting
First Posted : April 24, 2020
Last Update Posted : June 23, 2020
|Condition or disease||Intervention/treatment||Phase|
|COVID||Other: Systemic indirect endovenous ozone therapy||Phase 3|
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 (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Crossover Assignment|
|Intervention Model Description:||Control group with WHO recommended treatment. Treatment group with WHO recommended treatment + systemic ozone therapy.|
|Masking:||Double (Participant, Investigator)|
|Masking Description:||With a randomization table, nurses will treat the patients in treatment groups. Each patient will be in individual rooms.|
|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|
|Estimated Study Start Date :||July 2020|
|Estimated Primary Completion Date :||November 2020|
|Estimated Study Completion Date :||December 2020|
No Intervention: CONTROL
Base WHO recommended treatment.
Base WHO recommended treatment + Systemic indirect endovenous ozone therapy
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.
- COVID19 clinical scale [ Time Frame: through study completion, an average of 3 weeks ]World Health Organization (WHO) recommended COVID19 clinical scale
- Number of died patients [ Time Frame: through study completion, an average of 3 weeks ]Dead patients during the trial
- Oro/nasopharynx virus [ Time Frame: 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) [ Time Frame: through study completion, an average of 3 weeks ]Thorax imaging according scale. Higher punctuation is worse.
- Days in hospital [ Time Frame: through study completion, an average of 3 weeks ]Days in hospital
- Venous gas blood analysis [ Time Frame: through study completion, an average of 3 weeks ]Venous gas blood analysis
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04359303
|Contact: Jose Baeza Noci, MD, PhDfirstname.lastname@example.org|
|Contact: Francisco J Hidalgo Tallón, MD, PhDemail@example.com|