Rectal ozone therapy in high-risk symptomatic SARS-CoV-2 positive patients

ABSTRACT

ConditionCOVID-19
COVID-19
SARS-CoV2 ;Coronavirus Infections ;Coronaviridae Infections;Nidovirales Infections;SARS Virus;Betacoronavirus ;COVID-19;SARS-CoV2

InterventionGroup 1 Ozone (experimental). Rectal ozone therapy + Cuban national action protocol for Covid-19. Version 1.6..
Ozone therapy It will be applied by rectal insufflation according to the following scheme
Day 1 100 mL of gas with 30 µg / mL of Ozone concentration, (3 mg of ozone) every 12 hours
Day 2 150 mL of gas with 35 µg / mL of Ozone concentration, (5.25 mg of ozone) every 12 hours
Day 3-10 200 mL of gas with 40 µg / mL of Ozone concentration, (8 mg of ozone) every 12 hours.
The treatment will finish with 20 sessions of rectal ozone therapy for 10 days.
Cuban national action protocol for Covid-19. Version 1.6
Heberfer?n ® Interferon a-2b recombinant + Interferon gamma recombinant, according to the national form 3, 5 M IU, by intramuscular route, every three days, it is administered one day, two days are waited and it is applied again. Kaletra 2 tablets every 12 hours, for 10 days.
Chloroquine 1 tablet every 12 hours, for 10 days.
Broad spectrum antibiotics if you suspect bacterial over-infection (Ceftriaxone 1gr to 2gr every 12 hours in patients where associated bacterial infection is diagnosed. The decision to use another antibiotic will be determined by the results of laboratory studies and the microbiological map of the service). Treatment of comorbidities, according to their compensation status.
Group 2 Conventional therapy (Control). Cuban national action protocol for Covid-19. Version 1.6. This therapy is compound by
Heberfer?n ® Interferon a-2b recombinant + Interferon gamma recombinant, according to the national form 3, 5 M IU, by intramuscular route, every three days, it is administered one day, two days are waited and it is applied again. Kaletra 2 tablets every 12 hours, for 10 days.
Chloroquine 1 tablet eve;Interferon-alpha ;Interferon-gamma ;Interferons ;Anti-Bacterial Agents;Anti-Infective Agents ;Tablets ;Ceftriaxone;Chloroquine ;Administration, Rectal ;Injections, Intramuscular;Administration, Oral ;Insufflation ;Kaletra, Ozonetherapy

Primary outcome:1- RT-PCR (Negativization of the test) (Positive or negative). Measurement time Baseline, on the 5th, 7th and 10th days of treatment.
2- Clinical signs (mild, moderate, severe, critical). Measurement time Every day until finalizing the treatment. Will be classified as
Mild Fever, cough, sore throat, nasal congestion, slight headache, general malaise, diarrhea and / or vomiting. Normal radiology. Oxygen saturation greater than 95%.
Moderate Fever, cough, polypnea, slight changes in the Rx or lung ultrasound. Oxygen saturation greater than or equal to 90%.
Severe Fever, cough, polypnea, infiltrate / condensation Rx or lung ultrasound. Oxygen saturation less than 90% or requires VAM.
Critical ARDS, Sepsis or Septic Shock.
3- Evolution of the symptom (the same, better or worse). Measurement time Every day until finalizing the treatment.
4- Dyspnea (dysnea scale using the BORG method). Measurement time Every day until finalizing the treatment.
5- Oximetry (determination by digital oximetro). Measurement time Every day until finalizing the treatment.

CriteriaInclusion criteria 1) Hospitalized patients
2) between 19 and 80 years of age,
3) of both sexes
4) with a confirmed diagnosis of COVID-19 by TR-PCR.
5) That they have signed the informed consent to participate in the study.
6) Reported care patients with high risk mild and moderate symptoms according to hospital diagnostic criteria. High-risk patient (RA) patient 65 years of age or older, with or without comorbidities, and patient under 65 years of age with comorbidities.


Exclusion criteria 1) Pregnant or lactating patients.
2) Patients with glucose-6-phosphate-dehydrogenase deficiency proven analytically or by their medical history.
3) Chronic non-communicable diseases decompensated at the time of initiation of the trial
4) Cancer patients for being immunocompromised.
5) Patients with uncontrolled hyperthyroidism.
6) Patients with psychiatric illnesses, mental retardation or cognitive impairment that imply the psychological incompetence of the subject.
7) Scheduled surgery or other procedures that require general anesthesia during the study.
8) Patients who use immunosuppressants continuously, or who undergo an organ transplant within 6 months.
9) Patients with bleeding disorders, thrombocytopenia, active bleeding or who are under anticoagulant treatment.
10) Patients who participated in other clinical trials within the previous three months (eg. Vaccination with COVID 19 candidates)
11) Patients who were previously ill with COVID 19
12) People with allergies or hypersensitivity to medical ozone.
13) Patients with motor disabilities that make it difficult or impossible for them to move autonomously
14) Patients with more than two diarrhea a day.