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Hyperbaric Oxygen Therapy for hospitalized patients with Covid-19

Multicenter, prospective, randomized, double-blind clinical trial for the use of Hyperbaric Oxygen Therapy in patients hospitalized with Covid-19

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-2fvjjm
Enrollment
Unknown
Registered
2020-08-11
Start date
2020-08-18
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Other viral pneumonia

Interventions

Intervention group - a total of 20 participants will be allocated to the intervention group. Hyperbaric oxygen therapy sessions will be held daily and for five consecutive days. A pressure of 2.0 ATA
Other

Sponsors

Universidade Federal de Minas Gerais
Lead Sponsor
Universidade Federal de Juiz de Fora
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
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.

Secondary

MeasureTime frame
Death occurred in any of the places on your clinical trajectory (intra or extra hospital) as the maximum date on the 7th day of the study.;Outpatient treatment days, defined as day 8 minus the number of days from admission to discharge.

Countries

Brazil

Contacts

Public ContactJosé da Mota Neto

Universidade Federal de Juiz de Fora

motadort@gmail.com+55-31-999120909

Outcome results

None listed

Source: REBEC (via WHO ICTRP)