Therapeutic effect of rectal ozone therapy in high-risk symptomatic SARS-CoV-2 positive patients under intensive surveillance. Phase III clinical trial. (COVID-19) - OZO-COVID-002

ational Center for Scientific Research (CNIC)0 个研究点目标入组 292 人开始时间: 2021年7月15日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

研究类型: Interventional
分配方式: Randomized controlled trial. Masking: Open. Control group: Active. Assignment: Parallel. Purpose: Treatment

•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.

•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.

发起方

ational Center for Scientific Research (CNIC)