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3.
Int Immunopharmacol ; 90: 107261, 2021 Jan.
Article in English | MEDLINE | ID: covidwho-957149

ABSTRACT

BACKGROUND: There is still no specific treatment strategies for COVID-19 other than supportive management. DESIGN: A prospective case-control study determined by admittance to the hospital based on bed availability. PARTICIPANTS: Eighteen patients with COVID-19 infection (laboratory confirmed) severe pneumonia admitted to hospital between 20th March and 19th April 2020. Patients admitted to the hospital during the study period were assigned to different beds based on bed availability. Depending on the bed the patient was admitted, the treatment was ozone autohemotherapy or standard treatment. Patients in the case group received ozonated blood twice daily starting on the day of admission for a median of four days. Each treatment involved administration of 200 mL autologous whole blood enriched with 200 mL of oxygen-ozone mixture with a 40 µg/mL ozone concentration. MAIN OUTCOMES: The primary outcome was time from hospital admission to clinical improvement. RESULTS: Nine patients (50%) received ozonated autohemotherapy beginning on the day of admission. Ozonated autohemotherapy was associated with shorter time to clinical improvement (median [IQR]), 7 days [6-10] vs 28 days [8-31], p = 0.04) and better outcomes at 14-days (88.8% vs 33.3%, p = 0.01). In risk-adjusted analyses, ozonated autohemotherapy was associated with a shorter mean time to clinical improvement (-11.3 days, p = 0.04, 95% CI -22.25 to -0.42). CONCLUSION: Ozonated autohemotherapy was associated with a significantly shorter time to clinical improvement in this prospective case-control study. Given the small sample size and study design, these results require evaluation in larger randomized controlled trials. CLINICAL TRIAL REGISTRATION NUMBER: NCT04444531.


Subject(s)
Blood Transfusion, Autologous , Ozone/therapeutic use , Aged , Aged, 80 and over , Female , Humans , Kaplan-Meier Estimate , Male , Middle Aged , Treatment Outcome
4.
International Immunopharmacology ; 88:106879, 2020.
Article in English | WHO COVID | ID: covidwho-919641

ABSTRACT

OBJECTIVE: This study evaluated the potential efficacy of a novel approach to treat COVID-19 patients, using an oxygen-ozone (O2-O3) mixture, via a process called Oxygen-Ozone- Immunoceutical Therapy The methodology met the criteria of a novel, promising approach to treat successfully elderly COVID-19 patients, particularly when hospitalized in intensive care units (ICUs) Experimental design: We investigated the therapeutic effect of 4 cycles of O2-O3 in 50 hospitalized COVID-19 subjects suffering from acute respiratory disease syndrome (ARDS), aged more than 60 years, all males and undergoing non invasive mechanical ventilation in ICUs RESULTS: Following O2-O3 treatment a significant improvement in inflammation and oxygenation indexes occurred rapidly and within the first 9 days after the treatment, despite the expected 14-20 days A significant reduction of inflammatory and thromboembolic markers (CRP, IL-6, D-dimer) was observed Furthermore, amelioration in the major respiratory indexes, such as respiratory and gas exchange markers (SatO2%, PaO2/FiO2 ratio), was reported CONCLUSION: Our results show that O2-O3 treatment would be a promising therapy for COVID-19 patients It leads patients to a fast recovery from ARDS via the improvement of major respiratory indexes and blood gas parameters, following a relatively short time of dispensed forced ventilation (about one to two weeks) This study may encourage the scientific community to further investigate and evaluate the proposed method for the treatment of COVID-19 patients

5.
J Med Virol ; 2020 Oct 28.
Article in English | MEDLINE | ID: covidwho-893240

ABSTRACT

The evaluation of new therapeutic resources against coronavirus disease 2019 (COVID-19) represents a priority in clinical research considering the minimal options currently available. To evaluate the adjuvant use of systemic oxygen-ozone administration in the early control of disease progression in patients with COVID-19 pneumonia. PROBIOZOVID is an ongoing, interventional, randomized, prospective, and double-arm trial enrolling patient with COVID-19 pneumonia. From a total of 85 patients screened, 28 were recruited. Patients were randomly divided into ozone-autohemotherapy group (14) and control group (14). The procedure consisted in a daily double-treatment with systemic Oxygen-ozone administration for 7 days. All patients were treated with ad interim best available therapy. The primary outcome was delta in the number of patients requiring orotracheal-intubation despite treatment. Secondary outcome was the difference of mortality between the two groups. Moreover, hematological parameters were compared before and after treatment. No differences in the characteristics between groups were observed at baseline. As a preliminary report we have observed that one patient for each group needed intubation and was transferred to ITU. No deaths were observed at 7-14 days of follow up. Thirty-day mortality was 8.3% for ozone group and 10% for controls. Ozone therapy did not significantly influence inflammation markers, hematology profile, and lymphocyte subpopulations of patients treated. Ozone therapy had an impact on the need for the ventilatory support, although did not reach statistical significance. Finally, no adverse events related to the use of ozone-autohemotherapy were reported. Preliminary results, although not showing statistically significant benefits of ozone on COVID-19, did not report any toxicity.

6.
Am J Case Rep ; 21: e925849, 2020 Aug 17.
Article in English | MEDLINE | ID: covidwho-721633

ABSTRACT

BACKGROUND Pneumonia caused by coronavirus originated in Wuhan, China in late 2019 and has spread around the world, becoming a pandemic. Many patients deteriorate rapidly and require intubation and mechanical ventilation, which is causing the collapse of healthcare systems in many countries. Coronavirus infection is associated with extensive lung inflammation and microvascular thrombosis, which can result in hypoxia. It can also cause severe and lasting harm in other organs, including the heart and kidneys. At present, there is no proven and efficacious treatment for this new disease. Consequently, there is a growing tendency to use novel methods. Ozone therapy consists of administration of a mixture of oxygen and ozone (a molecule consisting of 3 oxygen atoms). The potential benefits of this therapy include reduced tissue hypoxia, decreased hypercoagulability, renal and heart protection, modulated immune function, improved phagocytic function, and impaired viral replication. CASE REPORT We report rapidly improved hypoxia with associated decreases in inflammatory markers and D-dimer immediately after 1-4 sessions of oxygen-ozone (O2-O3) therapy in 3 patients with COVID-19 pneumonia who presented with respiratory failure. Invasive mechanical ventilation was not required in these 3 patients. All patients were discharged home on days 3-4 after O2-O3 therapy. CONCLUSIONS O2-O3 therapy appears to be an effective therapy for COVID-19 patients with severe respiratory failure. Large controlled clinical trials are required to study the efficacy and safety of using O2-O3 therapy compared with the standard supportive case in patients with COVID-19 in terms of the need for invasive ventilation and length of hospital and intensive care unit stays.


Subject(s)
Betacoronavirus , Coronavirus Infections/therapy , Oxygen/therapeutic use , Ozone/therapeutic use , Pneumonia, Viral/therapy , Blood Transfusion, Autologous , C-Reactive Protein/analysis , Coronavirus Infections/diagnosis , Female , Ferritins/blood , Fibrin Fibrinogen Degradation Products/analysis , Humans , Hypoxia/therapy , Hypoxia/virology , Infusions, Intravenous , L-Lactate Dehydrogenase/blood , Lung/diagnostic imaging , Male , Middle Aged , Pandemics , Pneumonia, Viral/diagnosis , Radiography , Respiratory Insufficiency/therapy , Respiratory Insufficiency/virology
7.
Preprint | medRxiv | ID: ppmedrxiv-20117994

ABSTRACT

BackgroundThere is still no specific treatment strategies for COVID-19 other than supportive management. The potential biological benefits of ozonated autohemotherapy include reduced tissue hypoxia, decreased hypercoagulability, modulated immune function with inhibition of inflammatory mediators, improved phagocytic function, and impaired viral replication. ObjectiveTo determine the impact of the use of ozonated blood on time to clinical improvement in patients with severe COVID-19 pneumonia. DesignA Quasi-Randomized Controlled Trial determined by admittance to the hospital based on bed availability. SettingInternal Medicine ward at Policlinica Ibiza Hospital, Spain. ParticipantsEighteen patients with COVID-19 infection (laboratory confirmed) severe pneumonia admitted to hospital between 20th March and 19th April 2020. The mean age of the cohort was 68 years-old and 72% (n=13) were male. InterventionPatients admitted to the hospital during the study period were pre-randomized to different beds based on bed availability. Depending on the bed the patient was admitted, the treatment was ozone autohemotherapy or standard treatment. Patients in the therapy arm received ozonated blood twice daily starting on the day of admission for a median of four days. Each treatment involved administration of 200 mL autologous whole blood enriched with 200 mL of oxygen-ozone mixture with a 40 g/mL ozone concentration. Main OutcomesThe primary outcome was time from hospital admission to clinical improvement, which was defined as either hospital discharge or a two-point improvement in clinical status measured on a six-point ordinal scale. Secondary outcomes were clinical improvement measured on the 7th, 14th and 28th day after admission, as well as time to a two-fold reduction in concentrations of C-reactive protein, ferritin, D-dimer and lactate dehydrogenase. ResultsNine patients (50%) received ozonated autohemotherapy beginning on the day of admission. Ozonated autohemotherapy was associated with shorter time to clinical improvement (median [IQR]), 7 days [6-10] vs 28 days [8-31], p=0.04) and better outcomes at 14-days (88.8% vs 33.3%, p=0.01). In risk-adjusted analyses, ozonated autohemotherapy was associated with a shorter mean time to clinical improvement (-11.3 days, p=0.04, 95% CI -22.25 to -0.42). ConclusionOzonated autohemotherapy was associated with a significantly shorter time to clinical improvement in this quasi-randomized controlled trial. Given the small sample size and study design, these results require evaluation in larger randomized controlled trials.

8.
J Biol Regul Homeost Agents ; 34(3): 757-766, 2020.
Article in English | MEDLINE | ID: covidwho-401296

ABSTRACT

The aim of the multicentre study promoted by Nuova FIO is to evaluate the beneficial effects of the systemic Oxygen-Ozone (O2O3) therapy in patients suffering from SARS COV-2 disease in the early phases of the disease, before worsening, up to the need of tracheal intubation. The study is based on the rationale on that the systemic oxygen-ozone treatment could be effective, positively influencing the disease evolution and/or being able to mitigate the onset of the cytokine storm syndrome at least partially.


Subject(s)
Coronavirus Infections/therapy , Oxygen/therapeutic use , Ozone/therapeutic use , Pneumonia, Viral/therapy , Betacoronavirus , Humans , Pandemics
10.
IRCT; 2020-05-08; TrialID: IRCT20200406046968N3
Clinical trial register | ICTRP | ID: ictrp-IRCT20200406046968N3

ABSTRACT

Condition:

COVID-19.
COVID-19, virus not identified;U07.2

Intervention:

Intervention 1: Intervention group: In addition to the conventional treatments for Covid-19, patients will undergo a cycle of Ozone Major Autohemotherapy. In this method, a specific volume of patient's blood is drawn (100 to 200 cc in mild to moderate cases and 200 cc in severe cases). Then, a corresponding volume (100 to 200cc) of the oxygen-ozone gas mixture is added to the blood (initially with an ozone concentration of 35 micrograms/ml and gradually increasing it up to 45micrograms/ml in mild to moderate cases and up to 50micrograms/ml in severe cases). After mixing the blood with the gas mixture for at least 5 minutes with gentle rotating movements, the blood is reinfused to the patient. Mild to moderate cases will be treated daily for 4 days. Severe cases will be treated twice daily for at least 7 days. Intervention 2: Control group: Patients of this group, will just get the conventional treatments for COVID-19.

Primary outcome:

Quantitative CRP. Timepoint: Before and after the intervention. Method of measurement: Lab kit.;Oxygen Saturation. Timepoint: Before and after the intervention. Method of measurement: Pulse Oximetry.;Body's temperature. Timepoint: Before and after the intervention. Method of measurement: Thermometer.;Dyspnea. Timepoint: Before and after the intervention. Method of measurement: Subjective assessment of the patient and physical examination.;Cough. Timepoint: Before and after the intervention. Method of measurement: subjective assessment of the patient.;Diarrhea. Timepoint: before and after the intervention. Method of measurement: subjective assessment of the patient.;Headache. Timepoint: Before and after the intervention. Method of measurement: Subjective assessment of the patient.;Chills. Timepoint: Before and after the intervention. Method of measurement: Subjective assessment of the patient.

Criteria:

Inclusion criteria: Patients who have been diagnosed with COVID-19

Exclusion criteria: Patients with hypersensitivity to ozone
Patients with abnormal thyroid function tests
Patients with abnormal coagulation tests
Patients with G6PD deficiency
Pregnant or lactating women

11.
ClinicalTrials.gov; 24/04/2020; TrialID: NCT04366167
Clinical trial register | ICTRP | ID: ictrp-NCT04366167

ABSTRACT

Condition:

COVID;SARS-CoV 2;Pneumonia, Viral;Coronavirus Infection

Intervention:

Other: Oxygen-ozone therapy, probiotic supplementation and Standard of care;Dietary Supplement: SivoMixx (200 billion);Drug: Azithromycin;Drug: hydroxychloroquine

Primary outcome:

Delta in the number of patients requiring orotracheal intubation despite treatment

Criteria:


Inclusion Criteria:

- Age > 18 years

- Nasopharyngeal swab positive for COVID-19

- COVID-19 stages I - II - III (*1)

- Hospitalization in the Department of Infectious Diseases

Exclusion Criteria:

- COVID-19 stages IV - V - VI (*1)

- Hospitalization in Intensive Care Units

- Pregnancy

- Glucose-6-phosphate dehydrogenase (G6PD) deficiency

- Patients who deny consent to the proposed treatment

- Inability to provide informed consent

- Contraindications to performing oxygen-ozone therapy

- hyperhomocysteinemia

- favism or thyroiditis

- coagulopathies

- neurodegenerative diseases

- angina (in particular Prinzmetal's angina) or with previous myocardial infarction

(*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

Available on
http://www.siaarti.it/SiteAssets/News/COVID19%20-%20documenti%20SIAARTI/Percorso%20COVID-19
%20-%20Sezione%202%20-%20Raccomandazioni%20per%20la%20gestione%20locale%20-%20Rev%202.0.pdf

Last accessed 20/04/2020

Posted on 26.03.2020

On page 2 of the previous document :

"6 identified stages:

- sick disease - mild COVID-19 (I stage)

- light pneumonia - mild COVID-19 (II stage)

- serious pneumonia - severe COVID-19 (III stage)

- Acute respiratory distress syndrome (ARDS) - critical COVID-19 (IV stage)

- sepsis - critical COVID-19 (V stage)

- septic shock - critical COVID-19 (VI stage)"


12.
ClinicalTrials.gov; 22/04/2020; TrialID: NCT04366089
Clinical trial register | ICTRP | ID: ictrp-NCT04366089

ABSTRACT

Condition:

Covid-19

Intervention:

Biological: Cell therapy protocol 1;Biological: Cell therapy protocol 2

Primary outcome:

Adverse events assessment;Blood oxygen saturation

Criteria:


Inclusion Criteria:

- Confirmation of 2019-nCoV infection by RT-PCR

- Diagnosis of ARDS according to the Berlin definition of ARDS

- Requiring supplemental oxygen

- Pneumonia that is judged by chest radiograph or CT

- PaO2/oxygen absorption concentration (FiO2) = 300MMHG

- Pulmonary imaging shows that the focused progress > 50% in 24-48 hours

- Mild to Moderate 2019-nCoV pneumonia/ stay in the ICU <48 hours

- SOFA score between 2-3 point

Exclusion Criteria:

- Severe allergies or allergies after 1st injection to stem cell preparations and their
components

- Patients with a malignant tumor, other serious systemic diseases, and psychosis

- Co-Infection of HIV, tuberculosis, influenza virus, adenovirus, and other respiratory
infection viruses

- Patients with a previous history of pulmonary embolism

- Be thought by researchers to be inappropriate to participate in this clinical study
(Expected deaths within 48 hours, uncontrolled infections)

- Liver or kidney SOFA score of more than 3 points; combined with other organ failures
(need organ support), Stage 4 severe chronic kidney disease or requiring dialysis
(i.e. estimated glomerular filtration rate (eGFR) < 30)

- Pulmonary obstructive pneumonia, severe pulmonary interstitial fibrosis, alveolar
proteinosis, allergic alveolitis, and other known viral pneumonia or bacterial
pneumonia

- Continuous use of immunosuppressive agents or organ transplants in the past 6 months

- In vitro life support (ECMO, ECCO2R, RRT)

- Pregnant or lactating women

- Uncontrolled underlying disease


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