COVID-19 trials registries data warehouse

http://ensaiosclinicos.gov.br/rg/RBR-2fvjjm

José da Mota Neto

motadort@gmail.com

2020-08-11

Recruiting

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

Both sexes, age above 18 years, presenting with one or more of the following symptoms of acute respiratory infection, such as anosmia and / or dysgeusia, cough, fever above 37.8ºC, dyspnoea, sore throat, coryza, confirmed diagnosis of the disease (SARS-Cov-2) in the last 5 days by one of the current tests (with approval from a state or national regulatory agency), pending laboratory test result (SARS-Cov-2), but patient with a high clinical suspicion for COVID-19 indicated by the mandatory observation of all the following items, cough lasting less than or equal to 10 days, pulmonary infiltrates in the chest image (simple chest X-ray or computed tomography), hypoxemia defined as SaO2 less than or equal to 94%, no alternative explanation for symptoms of acute respiratory infection, recent contact with persons with suspected COVID-19 or recent return from travel from a place with a high number of cases, computed tomography scan of the chest with suggestive changes, performed no more than 24 hours before admission.

Present an usual contraindication to hyperbaric therapy, including untreated pneumothorax, spherocytosis, recent middle ear surgery, sinusitis, doxorubicin use, bleomycin, disulfiram, cisplatin, mafenide, as well as topical use of iodine and petrolatum.

2

Universidade Federal de Minas Gerais

18

100

Brazil

Severe disease at enrollment

6: Severe disease at enrollment

0

Number of days (hospitalization days) for the body temperature to return to its normal level (equal or above 37.8 ºC in the armpit). The assessments will be performed during the 05 days of the study.;Reduction in cough (subjective assessment performed every 6 hours). The assessments will be performed during the 05 days of the study.;Assessment of O2 saturation (SpO2) every 6 hours. The assessments will be performed during the 05 days of the study.;Daily assessment of arterial blood gases and partial pressure of O2 (PpO2). The assessments will be performed during the 05 days of the study.;Day of hospitalization on which patient assumed levels of respiratory improvement; during the 05 days of the study; according to graduation: a. hospitalized on mechanical ventilation; b. hospitalized with noninvasive ventilation or high flow nasal cannula; c. hospitalized with supplemental oxygen; d. hospitalized without supplemental oxygen.

Not reported

[{"arm_notes": "", "treatment_id": 608, "treatment_name": "Hyperbaric oxygen", "treatment_type": "Gas inhalation", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]