Rectal Ozone in the COVID-19 treatment

Not Applicable

• Conditions: Covid 19; COVID-19; Respiratory Tract Infections; Severe Acute Respiratory Syndrome; Betacoronavirus; SARS Virus; Nidovirales Infections; Coronavirus Infections; Coronaviridae Infections; Respiration Disorders

• Registration Number: RPCEC00000320
• Lead Sponsor: ational Center for Scientific Research (CNIC)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-06-05
• Study Completion: 2021-08-23
• Results First Posted: 2021-08-23
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 32

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Real-time polymerase chain reaction test-TR-PCR (Positive/Negative). Measurement time: day 0, day 6, day 11<br>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 <br>Progression of clinical signs (equal, better, worse). Measurement time : day 0 to day 11, day 15