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.
Several studies analyzed the mechanisms by which ozone therapy could combat viral infections. In particular, 1) the improvement of the release of oxygen in the peripheral tissues, 2) the anti-inflammatory action 3) a virucidal activity have been described. In view of these properties, a number of international clinical trials on the topic are currently ongoing. Hospitalization, dietary changes, use of antibiotics and systemic inflammation related to COVID-19 are all variables that contribute to changes in the intestinal and lung microbiota with significant repercussions on the outcomes of the disease. Furthermore, the use of ozone therapy could also lead to a modification of the microbial flora. Probiotic supplementation can help to correct these issues.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
152
\- systemic autohemotherapy with Ozone 30 mcg / ml 250ml 2 times / day for 7 days
Composition of SivoMixx: Streptococcus thermophilus DSM322245, Bifidobacterium lactis DSM 32246, Bifidobacterium lactis DSM 32247, Lactobacillus acidophilus DSM 32241, Lactobacillus helveticus DSM 32242, Lactobacillus paracasei DSM 32243, Lactobacillus plantarum DSM 32244, Lactobacillus brevis DSM 27961 (NB: DSM n°... : bacterial strain identification code)
dose: 500mg 1 cp / day (alternatively lopinavir/ritonavir cps 200/50 mg, 2 cps x 2 / day or darunavir 800 mg 1 cp / day + ritonavir 100 mg 1 cp / day or darunavir/cobicistat 800/150 mg 1 cp / day)
dose: 200 mg, 1 cp x 2 / day
Francesco Pugliese
Rome, RM, Italy
RECRUITINGDelta in the number of patients requiring orotracheal intubation despite treatment
Comparison between the two groups
Time frame: 21 days
Delta of crude mortality
Comparison between the two groups
Time frame: 21 days
Delta of length of stay for patients in hospital
Comparison between the two groups
Time frame: 90 days
delta in the value of interleukin (IL)-1
Comparison between the two groups
Time frame: 21 days
delta in the value of IL-6
Comparison between the two groups
Time frame: 21 days
delta in the value of IL-10
Comparison between the two groups
Time frame: 21 days
delta in the value of Tumor Necrosis Factor (TNF)-alpha
Comparison between the two groups
Time frame: 21 days
delta in the value of cluster of differentiation (CD)4+ CD38/ Human Leukocyte Antigen-DR isotype (HLA-DR)
Comparison between the two groups
Time frame: 21 days
delta in the value of CD8+ CD38/ HLA-DR
Comparison between the two groups
Time frame: 21 days
delta in the value of fecal calprotectin
Comparison between the two groups
Time frame: 21 days
delta in the value of lipopolysaccharide (LPS)
Comparison between the two groups
Time frame: 21 days
delta in the value of zonulin
Comparison between the two groups
Time frame: 21 days
delta in the value of alpha1-antitrypsin
Comparison between the two groups
Time frame: 21 days
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