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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of care | Active Comparator | Azithromycin 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), plus hydroxychloroquine cp 200 mg, 1 cp x 2 / day. |
|
| Oxygen-ozone and probiotic | Experimental | Oxygen-ozone therapy, probiotic supplementation plus standard of care Oxygen-ozone therapy: systemic autohemotherapy (twice a day). Probiotic supplementation: SivoMixx 200 billion (six sachets twice a day). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxygen-ozone therapy, probiotic supplementation and Standard of care | Other | - systemic autohemotherapy with Ozone 30 mcg / ml 250ml 2 times / day for 7 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Delta in the number of patients requiring orotracheal intubation despite treatment | Comparison between the two groups | 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| Delta of crude mortality | Comparison between the two groups | 21 days |
| Delta of length of stay for patients in hospital | Comparison between the two groups |
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Inclusion Criteria:
Exclusion Criteria:
(*1) Compliant with indications published by:
Italian Society of Anesthesia Analgesia Resuscitation and Intensive Care (SIAARTI).
Care pathway for the patient with COVID-19.
Section 2 - Recommendations for local management of the critically ill patient - Version 2
Last accessed 20/04/2020
Posted on 26.03.2020
On page 2 of the previous document :
"6 identified stages:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Francesco Pugliese, MD, PhD | Contact | 00390649978024 | f.pugliese@uniroma1.it | |
| Fabio Araimo, MD | Contact | f.araimo@policlinicoumberto1.it |
| Name | Affiliation | Role |
|---|---|---|
| Francesco Pugliese, MD, PhD | University of Rome Sapienza - Policlinico Umberto I Rome (Italy) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Francesco Pugliese | Recruiting | Rome | RM | 00161 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32303365 | Result | Hernandez A, Papadakos PJ, Torres A, Gonzalez DA, Vives M, Ferrando C, Baeza J. Two known therapies could be useful as adjuvant therapy in critical patients infected by COVID-19. Rev Esp Anestesiol Reanim (Engl Ed). 2020 May;67(5):245-252. doi: 10.1016/j.redar.2020.03.004. Epub 2020 Apr 14. | |
| 32228825 | Result | Conti P, Gallenga CE, Tete G, Caraffa A, Ronconi G, Younes A, Toniato E, Ross R, Kritas SK. How to reduce the likelihood of coronavirus-19 (CoV-19 or SARS-CoV-2) infection and lung inflammation mediated by IL-1. J Biol Regul Homeost Agents. 2020 March-April,;34(2):333-338. doi: 10.23812/Editorial-Conti-2. |
| Label | URL |
|---|---|
| Clinical study for ozonated autohemotherapy in the treatment of Novel Coronavirus Pneumonia (COVID-19) | View source |
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| SivoMixx (200 billion) | Dietary Supplement | 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) |
|
| Azithromycin | Drug | 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) |
|
| hydroxychloroquine | Drug | dose: 200 mg, 1 cp x 2 / day |
|
| 90 days |
| delta in the value of interleukin (IL)-1 | Comparison between the two groups | 21 days |
| delta in the value of IL-6 | Comparison between the two groups | 21 days |
| delta in the value of IL-10 | Comparison between the two groups | 21 days |
| delta in the value of Tumor Necrosis Factor (TNF)-alpha | Comparison between the two groups | 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 | 21 days |
| delta in the value of CD8+ CD38/ HLA-DR | Comparison between the two groups | 21 days |
| delta in the value of fecal calprotectin | Comparison between the two groups | 21 days |
| delta in the value of lipopolysaccharide (LPS) | Comparison between the two groups | 21 days |
| delta in the value of zonulin | Comparison between the two groups | 21 days |
| delta in the value of alpha1-antitrypsin | Comparison between the two groups | 21 days |
| 32150360 | Result | Cascella M, Rajnik M, Aleem A, Dulebohn SC, Di Napoli R. Features, Evaluation, and Treatment of Coronavirus (COVID-19). 2023 Aug 18. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK554776/ |
| A randomized controlled trial for the efficacy of ozonated autohemotherapy in the treatment of Novel Coronavirus Pneumonia (COVID-19) | View source |
| A multicenter randomized controlled trial for ozone autohemotherapy in the treatment of novel coronavirus pneumonia (COVID-19) | View source |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D018352 | Coronavirus Infections |
| ID | Term |
|---|---|
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| D017963 | Azithromycin |
| D006886 | Hydroxychloroquine |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D002738 | Chloroquine |
| D000634 | Aminoquinolines |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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