COVID-19 COVID-19 SARS-CoV2
Conditions
Interventions
Group 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 sch
Interferon-alpha
Anti-Bacterial Agents
Anti-Infective Agents
Tablets
Ceftriaxone
Chloroquine
Injections, Intramuscular
Administration, Oral
Kaletra, Ozonetherapy
Sponsors
National Center for Scientific Research (CNIC)
OSDE BioCubaFarma
Eligibility
Sex/Gender
All
Age
19 Years to 80 Years
Inclusion criteria
Inclusion 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1- C-reactive protein (mg/L). Measurement time: at Baseline, on the 5th, 7th and 10th days of treatment. 2- Dimero-D (ng/mL). Measurement time: at Baseline, on the 5th, 7th and 10th days of treatment. 3- Serum ferritin (ng/ml). Measurement time: at Baseline, on the 5th, 7th and 10th days of treatment. 4- Redox Balance Indicator: Malondialdehyde (mmol/mgHb), PAOP (mM/cloramina T), Nitric Oxide (uM); Glutathione (mM/mgHb), dismutase superoxide (U/mhHb min) and catalase (U/mgHb min). Measurement time: at Baseline, on the 5th, 7th and 10th days of treatment. 5- Hemogram: hemoglobin (g/L), hematocrit (%), red blood cells (erythrocytes) (x106/L), white blood cells (leukocytes) (x106/L), platelets (x109/L)and mean platelet volume (ft) and differential of leukocytes (lymphocytes (%), monocytes (%), basophils (%), eosinophils (%) and neutrophils (%), erythrocyte sedimentation (mm/h). Measurement time: Baseline, on the 5th, 7th and 10th days of treatment. 6- Blood biochemical: Lactate dehydrogenase (U/L), alanine amino transferase (U/L), aspartate amino transferase (U/L), creatinine kinase (mmol/L), gamma-glutamyl transferase (U/L), glucose (mmol/L), creatinine (umol/L), biliribine (umol/L), uric acid (mg/dL). Measurement time: Baseline, on the 5th, 7th and 10th days of treatment. 7- Chest X-ray (an evaluation scale will be classify inflammatory lung damage. Measuremetn time: Baseline and progressively according to the criteria of the attending physician. 8- Intestinal microbiota (positive or negative). Measurement time: Baseline, on the 5th and 10th days of treatment. | — |
Countries
Cuba
Contacts
Public ContactRodolfo Suarez Iznaga
Salvador Allende Hospital
Outcome results
None listed