Study on ozonated blood in COVID-19 severe pneumonia

Phase 1

Active, not recruiting

• Conditions: Covid-19 pneumonia; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-005020-11-ES
• Lead Sponsor: Políclinica Nuestra Señora del Rosario

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-02-01
• Last Update Posted: 10 May 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Men and women over 18 years of age.
2. Diagnosis of COVID-19 confirmed by positive nasopharyngeal PCR.
3. Lung infiltrate confirmed by imaging test (chest X-ray or CT) + patient with severe pneumonia (failure of > = 1 organ or SpO2 ambient air of <90% or respiratory rate> = 30) with need for oxygen with nasal canula , Venturi mask, non-rebreathing mask, high-flow nasal goggles or non-invasive mechanical ventilation (NIMV).
4. Evolution time of <2 weeks from symptom onset to recruitment.
5. Acceptance to participate in the study and signing of the consent form
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15

Exclusion Criteria

1. Patients who have received treatment with systemic ozone six months before admission to the hospital.
2. Patients who have previously experienced some type of adverse reaction to ozone therapy.
3. Patients who are aware of having a glucose-6-phosphate-dehydrogenase deficiency
4. Patients who are not able to clearly understand the objectives and methodology of the study.
5. Pregnant or lactating patients.
6. Patients who are intubated with invasive mechanical ventilation.
7. Patients with decompensated concomitant pathology and / or associated infectious pathology not related to COVID-19.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified