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

Not Applicable

• Conditions: COVID-19; SARS-CoV2; Coronavirus Infections; SARS Virus; Coronaviridae Infections; Nidovirales Infections; Betacoronavirus; Disease Prevention

• Registration Number: RPCEC00000341
• Lead Sponsor: ational Center for Scientific Research (CNIC)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-27
• Study Completion: 2020-12-01
• Results First Posted: 2021-01-15
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 200

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

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.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Virology- PCR SARS CoV 2 (Positive, Negative). Measurement time: Baseline and at day 10<br>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<br>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<br>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. <br>

Secondary Outcome Measures

Name	Time	Method
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.<br>