Prevalence of positive evolutive PCR in patients with COVID 19 treated with rectal ozone therapy: observational study prospective cohort.

Prevalence of positive evolutive PCR in patients with COVID 19 treated with rectal ozone therapy: observational study prospective cohort. (COVID-19) - OZONOTHERAPY-STUDY-OBSERVACIONAL

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

RPCEC

Registry ID

RPCEC00000341

Enrollment

200

Registered

2020-10-27

Start date

2020-08-15

Completion date

Unknown

Last updated

2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19 COVID-19 SARS-CoV2

Interventions

Rectal Ozonotherapy every 12 hours during 10 days (150 mL gas WITH 40 µg/mL Ozono concentration (8 mg Ozono) )

Medicine, Traditional

Administration, Rectal

Ozone therapy

Eligibility

Sex/Gender

All

Age

19 Years to 80 Years

Inclusion criteria

Inclusion criteria: Hospitalization patients between 19-80 years old, both sexes, persistent positive to SARS-CoV 2. To receive ozone therapy, the patient's must have given their consent

Exclusion criteria

Exclusion criteria: 1. Patients with uncontrolled hyperthyroidism 2. Patients with deficit glucose-6-fosfato-deshidrogenasa comprobate or by ancedent of clinic history. 3. 3. Chronic non-transmisible diseases decompensated at the beginning of the trial 4. Oncological patients because they are immunocompromised. 5. Patients with psiquiatric problems that imply the incompetence of the subject. 6. Surgery or other procedures that require general anesthesia during the study. 7. Patients use inmunosupresores or organs trasplants in previos 6 months. 8. Patients with coagulations trastorn, thrombocytopenia or active bleeding. 9. Patients with allergies or hypersensitivity to medical ozone. 10. Patients incorporated in another clinical trial.

Design outcomes

Primary

Measure	Time frame
1. Virology- PCR SARS CoV 2 (Positive, Negative). Measurement time: Baseline and at day 10 2. Clinical signs (Fever (Yes, No), Cephalea (Yes, No), Fatigue (Yes, No), Sore throat (Yes, No), Cough dehydrates (Yes, No), Others (Yes, No )). Measurement time: Baseline and at day 10 3. Hematology (Hemoglobin, hematocrit, erythrocytes, leukocytes with differential, Erythrosedimentation, using numerical values according to the units of the clinical sites). Measurement time: Baseline and at day 10 4. Biochemical (ALT, AST, GGT, Glucose, creatinine, albumin, uric acid, using numerical values according to the units of the clinical sites) Measurement time: Baseline and at day 10.	—

Measure

Time frame

1. Virology- PCR SARS CoV 2 (Positive, Negative). Measurement time: Baseline and at day 10 2. Clinical signs (Fever (Yes, No), Cephalea (Yes, No), Fatigue (Yes, No), Sore throat (Yes, No), Cough dehydrates (Yes, No), Others (Yes, No )). Measurement time: Baseline and at day 10 3. Hematology (Hemoglobin, hematocrit, erythrocytes, leukocytes with differential, Erythrosedimentation, using numerical values according to the units of the clinical sites). Measurement time: Baseline and at day 10 4. Biochemical (ALT, AST, GGT, Glucose, creatinine, albumin, uric acid, using numerical values according to the units of the clinical sites) Measurement time: Baseline and at day 10.

—

Secondary

Measure	Time frame
Adverse Events-AE (Name of AE, Intensity ((mild, moderate and severe), possible relation with the treatment (definitivamen related, probably related, possible, no related)). Measurement time: daily during 10 days.	—

Countries

Cuba

Contacts

Public ContactZullyt Zamora Rodriguez

National Center for Scientific Research

zullyt.zamora@cnic.cu

Outcome results

None listed

Source: RPCEC (via WHO ICTRP) · Data processed: Apr 4, 2026