Trial NCT04477954
Publication Cannellotto M, Emerg Med J, 2021 (published paper)
Dates: 2020-07-06 to 2020-11-30
Funding: Private (Biobarica. The article reports “The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors”. However, the Biobarica website reports early results of the trial and states that it was conducted using “Hyperbaric Chambers that were provided by BioBarica”
(https://www.biobarica.com/en/news/a-clinical-trial-demonstrates-the-effectiveness-of-hyperbaric-oxygenation-in-severe-patients-with-covid-19-tGsQmnVe2Kr5v6UIvtQ4/).
)
Conflict of interest: Yes
| Methods | |
| RCT Blinding: Unblinded | |
| Location :
Multicenter / Argentina Follow-up duration (days): 30 | |
| Inclusion criteria | Patients in emergency department (ED) or intensive care unit; over 18 years of age (all sexes); confirmed diagnosis of COVID-19 by PCR on nasal swab; pneumonia with oxygen dependence (defined as the need for continuous oxygen supply to maintain pulse oximetry saturation, SpO2 ≥93% or arterial gas with PaO2 ≥60 mm Hg); no previous hospitalisation within the last 6 months. |
| Exclusion criteria | Patients unable to give consent; pregnant or breast feeding; required mechanical ventilation; unable to maintain prolonged sitting position (≥2 hours); contraindications for HBO2 therapy (such as acute respiratory distress syndrome (ARDS), emphysema, air cysts or bullae and untreated pneumothorax, or severe chronic obstructive pulmonary disease). |
| Interventions | |
| Treatment
Hyperbaric oxygen therapy 90 minutes once daily for up to 5 days |
|
| Control
Standard care ( / ) Definition of Standard care: All patients were treated following the latest guidelines of the National Ministry of Health of Argentina. Standard treatment for COVID-19 consisted of supportive treatment, regular antimicrobial treatment for severe community-acquired pneumonia (ceftriaxone 2 g/day and azithromycin 500 mg/day for 7 days), dexamethasone 8 mg/day, paracetamol 1 g/6 hours in case of high temperature and monitoring for complications. Oxygen was supplied with a reservoir mask. | |
| Participants | |
| Randomized 40 participants (n1= / n2= ) | |
| Characteristics of participants N=40 Mean age : 55.3 26 males Severity : Mild: n=0 / Moderate: n=0/ Severe: n=40 Critical: n=0 | |
| Primary outcome | |
| In the register Time to normalize the oxygen requirement (oxygen dependence) [ Time Frame: 15-30 days. ] Time to normalize the oxygen requirement: Allowing a pulse oximetry value in ambient air greater than or equal 93% and/or arterial blood gas with PaO2 value greater than 60 mmHg in ambient air. | |
| In the report Proportion of patients that recovered from hypoxaemia and at 3, 5 and 10 days (to assess if patient recovered after two and five sessions) and median time to recovery within 30 days. Normalisation of oxygen requirement (oxygen independence) was defined as pulse oximetry value in ambient air ≥93% and/or arterial blood gas with a partial pressure of oxygen (PaO2) value of ≥60 mm Hg in ambient air. | |
| Documents available |
Protocol NR Statistical plan NR Data-sharing stated
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| Risk of bias Overall The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review |
Some concerns |
| General comment | In addition to the published article, the trial registry was used in data extraction and assessment of risk of bias. Neither protocol nor statistical analysis plan was available. The primary outcome in the article reflects that in the registry. The trial did not achieve its target sample size (n = 80) as a planned interim analysis showed benefit. |