Oxygen-Ozone as Adjuvant Treatment in Early Control of COVID-19 Progression and Modulation of the Gut Microbial Flora
Status:
Recruiting
Trial end date:
2020-12-31
Target enrollment:
Participant gender:
Summary
Italy was the first European country affected by a severe outbreak of the Severe Acute
Respiratory Syndrome - CoronaVirus-2 (SARS-CoV-2) epidemic emerged from Wuhan region (China),
with a high morbidity and mortality associated with the disease.
In light of its pandemic spread and the very limited therapeutic options, COronaVIrus Disease
19 (COVID-19) is considered an unprecedented global health challenge. Therefore, the
evaluation of new resources, designed in the first instance for other pathologies but
potentially active against COVID-19, represents a priority in clinical research.
This is an interventional, non-pharmacological, open, randomized, prospective, non-profit
study on the adjuvant use of oxygen ozone therapy plus probiotic supplementation in the early
control of disease progression in patients with COVID-19.
Contextually, all patients are treated with the current standard of care on the basis of the
interim guidelines of the Italian Society of Infectious and Tropical Diseases.
The main purpose of the study is to evaluate the effectiveness of an ozone therapy-based
intervention (accompanied by supplementation with probiotics) in containing the progression
of COVID-19 and in preventing the need for hospitalization in intensive care units.