COVID-19 Ozone Therapy notes

Ozone therapy / 2020-04-15

Many hospitals in Italy, Spain and China are now treating COVID-19 with reportedly “excellent”, “spectacular” results. Reports of these treatments appear in Italian and Spanish local news outlets but seem to be virtually unknown outside these regions. I’m trying to gather the information as it appears and collect it on this page, as well as other raw notes. Much of this is translated from Italian, Spanish or German.

Current clinical trials:

Current running trials I’ve found are:

  • NCT04366089 Started 2020-03-26, Rome. Randomized controlled, single-blind on outcomes assessor. ~152 participants. Treatment group receives systemic autohemotherapy with Ozone 30 mcg / ml 250ml 2 times / day for 7 days, plus standard of care. Control group receives standard of care. (Standard of care includes hydroxychloroquine and antibiotics.)
  • ChiCTR2000030165 Started 2020-02-22, Haihe Hospital, Tianjin. Non-random controlled. 15 mild ill and 15 severe or critical ill patients receive conventional treatment plus ozonated autohaemotherapy; 30 controls receive conventional treatment.
  • NCT04359303 Starting April 2020, Valencia, Spain. Randomized controlled double-blind. ~50 participants. Treatment group receive WHO-recommended treatment plus autohaemotherapy: 200 mL at 40 mcg/mL of medical ozone / oxygen in 200 mL of patient’s blood. Controls receive WHO-recommended treatment.
  • NCT04370223 Starting ~2020-05-04, Clinica Nuestra Señora del Rosario, Ibiza. Randomized controlled open-label. ~208 participants, all with COVID-19 pneumonia. Treatment group receive standard hospital treatment plus autohaemotherapy every 12 hours during 5 days (100-200ml of patient’s blood interacted with 200ml gas containing 40 μg/mL ozone). Controls receive standard hospital treatment.
  • NCT04388514 Started 2020-04-08; 90 participants, all with COVID-19 pheumonia: randomized 45 with standard of care plus blood ozonation; 45 with standard of care. Single-blind (investigator). Measuring time of respiratory improvement and weaning from O2 support, length of hospitalization, length of ICU support, improvement in chest imaging, improvement in cytochine release syndrome (measuring IL-6, lymphocyte typing for CD4, CD3, CD8, HLA-DR, CD45)
  • NCT04400006 studying ozone therapy as a preventative. Started 2020-05-06, Marmara University Istanbul, Turkey. Phone survey of adults who have received at least 10 major autohaemotherapy treatments in the 6 months prior to first reported Turkish COVID-19 case.
  • https://www.irct.ir/trial/47149 Starting ~2020-04-23, Baqiyatallah University of Medical Sciences, Iran. Randomized, controlled, non-blinded. Target of 80 participants. Treatment group receive ozone major autohaemotherapy (100-200cc blood interacted with equal volume of 35μg/mL ozone; volume depending on severity) 1-2 times daily depending on severity of disease, plus conventional treatment. Controls receive conventional treatment.

Two other trials (apparently failed to receive ethics approval? not sure if these are running or not): ChiCTR2000030006 and ChiCTR2000030102

Medical/scientific articles and letters on ozone therapy:

Study results reporting positive outcomes:

Study results reporting ambivalent or negative outcomes:

Proposals, discussions of potential mechanisms, etc:

Email I sent to NZ medical authorities 13 April 2020:

Dear Sir or Madam,
Ozone therapy is being trialed in Italy and Spain to treat covid-19 patients, with reportedly excellent results. Prompt adoption in NZ may greatly reduce our number of deaths.
Ozone therapy has been widely used for decades in some countries. It has a good safety record and substantial supporting evidence in medical literature. It has shown promise as an antiviral drug in a number of in-vitro and in-vivo studies, and is now being trialed in 17 hospitals in Italy and one hospital in Spain, as well as (I understand) in several Chinese and Iranian hospitals.
Preliminary results are described as “excellent” and “spectacular”, with rapid recovery from hypoxemia and improved radiological results.
The Italian researchers were, as of their latest reports, still awaiting regulatory and ethical approval to conduct a randomized controlled study.
Ozone therapy is safe, simple, quick to administer and extremely cheap. It is compatible with other treatments, and has few contraindications. There are several proposed mechanisms for its efficacy in treating viral cases:
  • Direct oxidation of sulfhydral groups in the virion’s spikes, neutralising the virus in the bloodstream.
  • Cytokine regulation: Ozonides in the bloodstream induce the synthesis of 4-hydroxynonenal (4-HNE) which in turn induces anti-inflammatory cytokines and suppresses pro-inflammatory cytokines, preventing cytokine storm.
  • Stimulates increased release of immune-active cytokines, via NFAT transcription factors.
  • Anti-thrombotic activity as result of ozonides stimulating endothelial cells to release nitroxide (NO), which in turn acts to reduce blood viscosity and platelet aggregation and increases availability of oxyhaemoglobin to cells. Diffuse thrombosis is a major factor in covid-19 deaths.
Here is a good summary of the research, which is worth careful reading: https://foxvalleywellness.com/files/ozone-therapy-covid19.pdf See also the second report of the Italian researchers (below, at the end of this email), which goes into more detail regarding cytokine-regulatory and anti-thrombotic effects.
I am not an ozone therapist, nor affiliated with any ozone proponents. I am simply a concerned citizen with a scientific background who has been critically reviewing the literature. Especially with regard to safety, I have actively sought opposing evidence. The therapy appears to be safe, its claims appear plausible, and the glowing reports of initial trials on covid-19 patients suggest that prompt adoption in NZ could save many lives.
I am aware that results are so far preliminary and unproven; test groups are small and control groups are not clearly described. We should expect clearer information when formal results of Italian and Spanish randomized controlled trials are published, but I hope we can act sooner than that.
In New Zealand, ozone therapy, while not prohibited, is not widely credited by mainstream medicine. It is not patented and offers no financial profit, so extensive drug trials have never been funded. Yet given its excellent safety record and its compatibility with other treatments, I believe there is nothing to lose and potentially everything to gain from using it in NZ hospitals. Please share this email with anyone who could help evaluate and act on this information. Don’t hesitate to contact me with any questions, though I also recommend contacting the Spanish and Italian groups, who have offered their help to other hospitals. The best contact details I can find are:
Spanish group:

Italian group:

  • Prof. Marianno Franzini, Società Scientifica di Ossigeno-Ozono Terapia (SIOOT): info@ossigenoozono.it
Thank-you, and best wishes,
Ben Whitmore
[redacted address]
[redacted phone number]
[redacted email address]
Translation of Italian news article cited above:
“Ozone treatment tested at Udine hospital: only one out of 36 is intubated” (Messagero newspaper, 5 April 2020)
==Article begins==

Only one of the thirty-six Covid-19 patients treated with ozone has entered intensive care and is intubated. All the others, despite having developed pneumonia and severe respiratory difficulties, have shown a reversal and, shortly, will return to their families. The results are there for all to see: the Anesthesia and Resuscitation Team together with that of the Infectious Diseases of the Central Friuli University Health Authority, led by the anesthesiologist Amato De Monte and the infectious disease specialist Carlo Tascini, await authorization from the Italian Medicines Agency (Aifa) and the Ethics Committee of the Spallanzani Institute of Rome to start a prospective randomized and controlled study. The goal is to evaluate the effectiveness of ozone treatment in patients who have developed coronavirus infection.The clinical study will be carried out with other Italian centers that believe in the therapy developed in the Santa Maria della Misericordia hospital, by the director of the Department of Anesthesia and Resuscitation and by the Professor of Infectivology at the University of Friuli. Alongside De Monte and Tascini there are also Mattia Buttazzoni, Cristiana Macor, Carola Martellon, Ermal Rica, Giovanni Sermann and the staff of the inter-company analysis laboratory directed by Professor Francesco Curcio.

It is a close-knit team, engaged for weeks in an exchange of knowledge that has lit a light in the coronavirus tunnel. He indicated a path that could — the conditional is important — lead to a therapy that in the worst case does not give results, does not cause side effects and does not compromise the results of other therapies used so far. But if, as has been found in the 36 patients treated, it is established that the use of ozone significantly reduces entries into the intensive care units, the turning point could write a page of history in the fight against the novel virus.

In Udine, in the 36 patients undergoing ozone therapy, the percentage of intubated patients fell from 15 to 3 percent. In itself, the treatment is simple: “We take 200 ml of blood which we let interact for about ten minutes with the ozone and then re-inject it into the patient.”

“The procedure must be repeated three, four times at most” explain De Monte and Tascini in pointing out that the therapy is cheap and avoids ending up in the intensive care unit where the greatest number of deaths occurs. In these cases, prudence is never too much even if the initial results bode well. “The clinical study” – adds Tascini – “will allow us to verify whether ozone-based infusion therapy can restore the immune system.”

==Article ends==

Second report of the Italian Scientific Society of Oxygen Ozone Therapy (SIOOT), as translated by the UK Ozone Society:

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Further reports and news items:

http://www.ossigenoozono.it/IT/News/3506/PRIMO_REPORT_-_OSSIGENO_OZONO_SIOOT_NEI_PAZIENTI_RICOVERATI_CON_COVID-19
FIRST REPORT ON THE USE OF SIOOT OZONE OXYGEN IN RECOVERED PATIENTS WITH COVID-19
Bergamo, April 1, 2020

TREATED PATIENTS 11
INTUBATED PATIENTS 4
NON-INTUBATED PATIENTS 7

5 DAYS OF TREATMENT – 1 GAEI PER DAY
EXTUBATED PATIENTS 1
PATIENTS CURRENTLY INTUBATED 2
PATIENTS NOT INTUBATED WITH OXYGEN NON-INVASIVE THERAPY 6
PATIENTS INTUBATED AND DEAD FROM BACTERIAL SUPERINFECTION AND SEPTIC SHOCK 1
HEALED PATIENTS WITH TWO NEGATIVE SWABS 1

After the 5 treatments with SIOOT Ozone Ozone Therapy, excluding the only deceased, we observed:
1. General improvement of clinical conditions
2. Normalization of body temperature (fever)
3. Reduction of PCR (reactive protein C)
4. Normalization of heart rate
5. Improvement of saturation and reduction of oxygen support
6. Normalization of renal function (creatinine)

After the 5 treatments carried out we recommend:
– Continue Oxygen Ozone Therapy treatment, carefully respecting the SIOOT protocol.
– Recommended examinations for the follow-up of each patient (PCD, LDH, INTERLEUCHINE as far as possible, CREATININE, ELECTROLYTES, GLYCEMIA)
– Continue with the drug therapy already set

PLEASE SEND WEEKLY, BY MONDAY ON
REPORT OF TREATED PATIENTS.

http://www.ossigenoozono.it/IT/News/3508/SECONDO_REPORT_-_OSSIGENO_OZONO_SIOOT_NEI_PAZIENTI_RICOVERATI_CON_COVID-19
Second report on SIOOT oxygen ozone in 46 patients, from the least serious to the most serious with covid-19. Of these, 39 patients significantly improved.

Patients treated: 46
Intubated patients: 11
Non intubated patients: 35

Average of 5 oxygen ozone therapy treatments
Extubated patients: 6
Currently intubated patients: 3
Patients who have not had to be intubated: 28
Intubated and deceased patients from bacterial superinfection, septic shock, pulmonary embolism and myocarditis (2 treatments): 4
Patients recovered with two negative swabs: 5

N.B. The currently available data is that SIOOT oxygen ozone therapy is indicated mainly for patients before intubation.

It is confirmed that:
1. General improvement of clinical conditions.
2. Normalization of body temperature.
3. Reduction of PCR (reactive protein C).
4. Normalization of heart rate.
5. Improvement of saturation and reduction of oxygen support
6. Normalization of renal function (creatinine)
7. Increase in leukocytes

Bergamo, 9/04/2020

Sharing clinical trial data is in everyone’s interest: patients, clinicians, regulatory authorities

http://backoffice.ossigenoozono.it/Multimedia/Content/TERZO_REPORT_-_24042020.pdf

THIRD REPORT ON OXYGEN OZONE SIOOT
In 73 patients, from least to most serious with COVID-19.
Of these, 61 decisively improved patients.

TREATED PATIENTS: 73 (24 intubated, 49 non-intubated)

AVERAGE OF 5 OXYGEN OZONE THERAPY TREATMENTS

  • Extubated patients: 15
  • Patients still intubated: 5
  • Patients who did not require intubation: 36
  • Patients intubated and dead from bacterial superinfection, septic shock, pulmonary embolism and myocarditis (2 treatments): 7
  • Recovered patients with two negative swabs: 10

N.B. The immediately noticeable data is that SIOOT Oxygen Ozone Therapy
is mainly indicated in phase 1 and 2 patients, and in any case
before intubation. These data suggest that if the intervention were done at home it would have even greater success than at present.
It is reconfirmed:
1. General improvement of clinical conditions
2. Normalization of body temperature
3. Reduction of PCR (reactive protein C)
4. Normalization of heart rate
5. Improvement of saturation and reduction of oxygen support
6. Normalization of renal function (creatinine)
7. Increased leukocytes and lymphocytes

Bergamo, 24/04/2020
Sharing clinical trial data is in everyone’s interest: PATIENTS, CLINICS, REGULATORY AUTHORITIES
Prof. Luigi Valdenassi Prof. Marianno Franzi

http://www.ossigenoozono.it/IT/CovidDetail/3514/QUARTO_REPORT_-_DATI_EMATOCLINICI_DEI_PAZIENTI_TRATTATI_CON_OSSIGENO_OZONO_TERAPIA_SIOOT

May 4, 2020
Hematoclinical tests provided by the various hospitals active with Ozone Ozone Therapy treatment.
In detail, the values ​​of the Covid19 patients before and after treatment with Oxygen Ozone Therapy (3/4 average treatments) are indicated.
Number of patients: 73
Step number 3 / 4
April 28, 2020
Initial average value After 3-4 treatments with O2O3
Body temperature 37.7° – 38.7° 36° – 36.5°
Cardiac Fr 90 – 100 70 – 75
S. O2: intubated <70 intubated
S. O2: Not Intubated 80 – 85 92 – 95
Blood sugar 200 – 300 90 -150
Transaminases 90 – 250 40 – 50
Creatinine 1.5 – 3.5 1 – 1.3
Electrolytes: Na – K –Ca < the norm In the norm
Leukotics 3,000 – 4,000 > 5,500
Lymphocytes Very serious <3 very serious <7
Serious <10 Serious 10 – 20
Moderate 10 – 15 Moderate 15 – 20
Slight 15 – 20 Slight 25 – 30
PCR 10 – 200 <10
LDH 300 – 350 <250
Didimero 600 – 2000 400 – 500
Didymero> 3,000 8,000 – 15,000 Thromboembolism
Procalcitonin <0.5 ng / ml <0.05
Procalcitonin > 5 ng / ml Superinfection

Associated therapy: in the judgment of the attending physician
Observation: Patients not treated with associated ozone therapy had a slower recovery. We observed that patients with seasonal flu shots had significant symptoms.

Clinical evolution with improvement of cardiac function.

EARLY GAE: (1st-2nd day hospitalization) COVID19 confirmed ==> Patients: Serious, moderate, mild ==> Clinical evolution without neurological complications. UNHARMED.
EARLY GAE: (1st-2nd day hospitalization) COVID19 confirmed ==> Patients with MYOCARDITIS (ELECTROCARDIOGRAM) ==> Clinical evolution with improvement of cardiac function.

O2O3 protocol: Method according to the provisions of SIOOT in the 5 phases

O2O3 materials:
– Multiossigen Medical 95 CPS device
– SANO3 bag, specially certified

http://www.ossigenoozono.it/IT/CovidDetail/3518/I_DATI_EMATOCLINICI_DIMOSTRANO_L’EFFICACIA_DELL’OSSIGENO_OZONO_TERAPIA_CON_PROTOCOLLI_SIOOT

N° Patients: Total 80: 40 with O3 and 40 without
Report 5
15 May 2020

HEMATOCLINICAL DATA DEMONSTRATE THE EFFECTIVENESS OF OXYGEN OZONE THERAPY WITH SIOOT PROTOCOL IN THE TREATMENT OF COVID19

Number of patients: 40 Number of patients: 40
PATIENTS TREATED WITH STANDARD THERAPY + SIOOT OXYGEN OZONE PATIENTS TREATED ONLY WITH STANDARD THERAPY
Average initial value After 3-4 treatments O2O3 Average% Average initial value Final value after 15 days Average %
Body temperature 38.7 36.5 -5% 38.6 37.9 -2%
Blood sugar 300 150 -50% 171 134 -25%
Creatinine 3.5 1.3 -60% 1.27 1.50 +15%
Leukotics 3000 5500 +80% 6379 8354 +31%
Lymphocytes1 15 30 +100% 15.48 21.38 +40%
PCR 10 <10 -50% 7.46 5.97 -20%
D-didimer2 1300 500 -54% 1020 939 -10%

1More lymphocytes means immune response / capacity
2High D-dimer levels → TEP (pulmonary embolism / microthrombosis) risk → death risk

Associated therapy: in the judgment of the attending physician
Observation: Patients not treated with Oxygen Ozone Therapy had a slower recovery*1

EARLY GAEI: (1st-2nd day hospitalization) COVID19 confirmed → Patients: Serious / moderate / mild → Clinical evolution without neurological complications. Cured.
EARLY GAEI: (1st-2nd day hospitalization) COVID19 confirmed → Patients with PERICARDITIS/MYOCARDITIS (forms of microvasculitis). ELECTROCARDIOGRAM → Clinical evolution with improvement of cardiac function.

O2O3 protocol:
Method according to the provisions of SIOOT in the 5 stages

O2O3 materials:
– Equipment with ozonation tubes of minimum length of 60 cm, A.T. transformers producing at least 16,000 volts, oxygen flow variable from 1 to 10 liters.
– SANO3 bag, specially certified without phthalates.

*1Slower response and > late complication with metabolic syndrome (renal failure, microthrombosis, fever)

https://www.farodiroma.it/nei-casi-di-covid-19-lossigeno-ozono-e-altamente-efficace-ce-un-miglioramento-in-tutti-i-pazienti-trattati/
Gives more detail regarding the second SIOOT report. Excerpts:
“Together with prof. Luigi Valdenassi, national president of SIOOT, Franzini is collecting and analyzing data from the 20 hospitals that are currently treating people affected by Covid-19 in Italy according to the medical protocol of ozone therapy formulated by SIOOT.”
“Yesterday the data arrived for 46 patients, hospitalized in 6 different hospitals, who were treated with 5 sessions of Oxygen Ozone Therapy. Analyzing the parameters it turns out that ozone oxygen is highly effective. There is a rapid and evident improvement in all treated patients. Of the 11 intubated and intensive care patients, 6 were extubated after ozone oxygen treatment, 1 improved, while 4 died before being able to practice the entire ozone therapy cycle. Prof. explained Franzini that the conditions of the four deceased patients were very serious. They suffered from bacterial superinfection, septic shock, pulmonary embolism and myocarditis. ‘By studying the medical records’, Franzini said, ‘I was able to observe the lung plates and I swear I have never seen lungs so compromised’.”
“Thanks to ozone oxygen treatment, 28 patients improved significantly and did not need to be intubated. 5 patients who, after 5 ozone therapy sessions tested negative for the double tampon, have already returned home. There are still 3 ICU patients who continue to be treated with oxygen, ozone. Franzini has specified that, from the cross comparison of the analyzes, confirmation is obtained that the oxygen ozone has managed to improve the health conditions of all patients undergoing therapy. Based on these findings, the international president of SIOOT argued that the time has come for a change of pace in the virus contrast strategy. ‘Experience is telling us’, he stressed, ‘that the Covid-19 virus must be attacked immediately when it is weaker, for this reason, people who are positive should be treated immediately. Starting with those who are at home in quarantine’. ‘We understand’, he added, ‘that leaving people at home waiting for fever and other symptoms to occur is very dangerous, because once the virus has attacked the lungs, the circulatory and kidney systems, it becomes more difficult to deactivate it.’.”

http://backoffice.ossigenoozono.it/Multimedia/Content/Oxygen-ozone_immunoceutical_therapy_in_COVID-19_outbreak_facts_and_figures.pdf
Oxygen-ozone immunoceutical therapy in COVID-19 outbreak: facts and figures
Giovanni Ricevuti, Marianno Franzini, Luigi Valdenassi
Ozone Therapy 2020 5:9014

 

Facebook post: “Potential mechanisms by which the oxygen-ozone (O2-O3) therapy could contribute to the treatment against the coronavirus COVID-19” has been accepted for publication in European Review for Medical and Pharmacological Sciences.

 

https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3561379
Case Report: Recovery of One ICU-Acquired COVID-19 Patient Via Ozonated Autohemotherapy
Wu Junping et al.
Haihe Hospital, Tianjin University, China

https://www.agronline.it/sanita/l-ozonoterapia-puo-combattere-il-covid-19-primi-risultati-positivi-di-uno-studio-italiano_19315
A news article describing the relation of SIOOT with China and how Prof. Dong Ming of Tianjin University has developed a protocol yielding positive results.

https://www.orbisphera.org/Pages/PrimoPiano/1995/Il_Collegio_Medico_dell%E2%80%99Universit%C3%A0_di_Tianjin_conferma_che_l%E2%80%99Ossigeno_Ozono_Terapia_%C3%A8_efficace_contro_il_Covid-19
THE MEDICAL COLLEGE OF TIANJIN UNIVERSITY CONFIRMS THAT OXYGEN OZONE THERAPY IS EFFECTIVE AGAINST COVID-19

 

Notes regarding safety

Direct intravenous and intra-arterial injection of O2/O3 gas used to be widely practiced in Germany in the 1970s and early 1980s and has a history of serious side-effects, including death. In each case the clinical picture was consistent with either gas embolism or allergic shock. This method of delivery is now considered malpractice by most (though not all) practitioners.

One case of apparent allergic shock following a very small amount of gas injected raises the unknown possibility that other forms of delivery such as autohaemotherapy could also carry a risk of allergic shock.

One case of heart attack has been noted, which followed some hours after a major autohaemotherapy; but the contribution of the therapy in this case is disputed. There have also been reports of hepatitis C being transmitted by ozone therapy.

Otherwise, there seems little report of adverse effects. Ro and Rowen claim they have between them performed over 60,000 major autohaemotherapies over 30 years with no side effects.

Notes on the infamous German safety study

 

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