COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04370223

Alberto Hernández, MD, PhD

albimar23@yahoo.es

2020-04-30

Not recruiting

RCT

Randomized

Parallel

Open label

multi-center

Treatment

inclusion criteria: - diagnosis of covid-19 confirmed by positive polymerase chain reaction (pcr) for severe acute respiratory syndrome (sars-cov-2) in respiratory tract sample, plus pneumonia confirmed by imaging tests and arterial oxygen saturation (spo2) <94% with ambient air or a partial pressure of oxygen to fraction of inspired oxygen (po2/fio2) ratio <300 mmhg or spo2/fio2 ≤ 315. - acceptance to participate in the study and signing of the informed consent.

- patients who have received treatment with any form of ozone therapy 6 months before admission to the hospital. - patients who have previously been treated and have experienced some type of adverse reaction to ozone therapy. - patients aware of having a deficiency of glucose-6-phosphate dehydrogenase. - patients with clinically decompensated chronic comorbidities, independently of covid-19. - patients suffering from any psychiatric disorder specified in axis i of the diagnostic and statistical manual of mental disorders (dsm-v), other than major depression. - patients who are not able to clearly understand the objectives and methodology of the study. - pregnant or lactating patients.

2

Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta

18

90

Spain

Severe disease at enrollment

6: Severe disease at enrollment

208

Rate of patients achieving improvement in clinical condition at day 14 after recruitment

None

Phase 3

[{"arm_notes": "", "treatment_id": 951, "treatment_name": "Ozonated autohemotherapy", "treatment_type": "Life support", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]