Covid 19 COVID-19
Conditions
Interventions
Group 1 (Experimental): Treated with increasing dose of rectal ozone therapy (100 mL of gas with 30 µg / mL Ozone concentration every 12 hours x 1 day, 150 mg at 35 µg / mL every 12 hours the next da
Oseltamivir
Chloroquine
Tablets
Administration, Oral
Injections, Intramuscular
Ozone therapy,
Kaletra,
Heberferon
Sponsors
National Center for Scientific Research (CNIC)
Eligibility
Sex/Gender
All
Age
19 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1- Hospitalized patients between 19 and 80 years, of either sex with a diagnosis confirmed by COVID-19 PCR-TR. 2- Patients who signed the informed consent to participate in the study. 3- Reported care patients with mild and moderate symptoms according to hospital diagnostic criteria (fever, dry cough and sore throat)
Exclusion criteria
Exclusion criteria: 1- Pregnant or lactating patients. 2- Patients with uncontrolled hyperthyroidism. 3- Patients with glucose-6-phosphate dehydrogenase deficiency verified analytically or due to their medical history. 4- Chronic non-communicable diseases decompensated at the start of the trial. 5- Cancer patients due to being immunocompromised. 6- Patients with psychiatric illnesses that imply the 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 or active bleeding. 10- People with allergies or hypersensitivity to medical ozone. 11- Patients who participated in other clinical trials within the previous three months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Real-time polymerase chain reaction test-TR-PCR (Positive/Negative). Measurement time: day 0, day 6, day 11 Clinical signs (fever, pain head, fatigue, sore throat, dry cough, dyspnea. Every signs evaluted like Yes/No). Measurement time: day 0 to day 11, day 15 Progression of clinical signs (equal, better, worse). Measurement time : day 0 to day 11, day 15 | — |
Secondary
| Measure | Time frame |
|---|---|
| C-reactive protein (values at mg/L). Measurement time: day 0, day 6, day 11 Serum ferritin (values at ug/L). Measurement time: day 0, day 6, day 11 Redox balance indicators (MDA (values at mmol/L). Total hydroperoxides (values at mmol/L). Nitric oxide (values at µmol/L). Glutathione (values at mmol/L). SOD (values at mmol/L). CAT (values at mmol/L)). Measurement time: day 0, day 6, day 11 Complete blood count (Hemoglobin (values at g/dL). Hematocrit (values at %). Red Blood Cells-Erythrocytes (values at x10^6/L), White Blood Cells-Leukocytes (values at x10^9/L), Plateles (values at x10^9/L), Lymphocytes (values at %), Monocytes (values at %), Eosinophils (values at %), Basophils (values at %), Neutrophils (values at %), Erythrocyte sedimentation (values at mm/h)). Measurement time: day 0, day 6, day 11 Blood chemistry (Albumin (values at g/L), LDH (values at U/L), ALT (values at U/L), AST (values at U/L), GGT (values at U/L), Creatinine (values at umol/L), Glucose (values at mmol/L), Bilirubin (values at mg/dl), Uric acid (values at mg/dl), Cholesterol (values at mmol/L), Triglycerides (values at mmol/L), HDL(values at mmol/L)). Measurement time: day 0, day 6, day 11 | — |
Countries
Cuba
Contacts
Public ContactZullyt Zamora Rodriguez
National Center for Scientific Research (CNIC)
Outcome results
None listed