Rectal ozone therapy in high-risk symptomatic SARS-CoV-2 positive patients

Phase 3

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

• Registration Number: RPCEC00000383
• Lead Sponsor: ational Center for Scientific Research (CNIC)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-07-15
• Study Completion: 2022-01-11
• Results First Posted: 2022-03-11
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 292

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified