COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04619719

Enoch Huang

Not reported

2020-11-06

Terminated

RCT

Randomized

Parallel

Open label

multi-center

Treatment

inclusion criteria: age > 18 years positive covid 19 test or clear clinical diagnosis of covid-19. positive covid-19 test will be confirmed based on a pcr or antigen test result or patient reported history. clear clinical diagnosis of covid-19 will be a combination of respiratory symptoms and clinical findings based on laboratory values and radiographs. moderate to severe hypoxemia defined by a baseline supplemental oxygen requirement of 6 liters or higher (including high flow oxygenation devices) as measured within the 24 hours before enrollment

pregnancy untreated pneumothorax, which must be evaluated with a baseline chest radiograph or computerized tomography scan at least 72 hours prior to enrollment presence of pneumomediastinum, pneumopericardium, significant subcutaneous emphysema, or pulmonary blebs, which should also be evaluated with a baseline chest radiograph prior to enrollment current invasive mechanical ventilation current non-invasive mechanical ventilation any patient who will not be stable for transport to the hyperbaric chamber, in addition to any relative contraindications identified by the treating hyperbaric physician or inpatient hospital team (e.g., severely impaired cardiac output due to significant myocardial injury). any patient without the capacity to provide informed consent

2

Legacy Health System

18

100

United States

Severe disease at enrollment

6: Severe disease at enrollment

27

Incidence of 60-Day Patient Mortality

None

Not reported

[{"arm_notes": "", "treatment_id": 608, "treatment_name": "Hyperbaric oxygen", "treatment_type": "Gas inhalation", "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"}]