To determine whether inhaled Yabro protects against progression of COVID19-induced respiratory failure preventing the passage to non-invasive ventilation (NIV) and promotes recovery from COVID19 lung disease in hospitalized patients.
All patients will be treated with state of the art COVID19 treatment as per the treating clinician (Remdesivir, systemic corticosteroids, monoclonal antibodies, convalescent plasma, biologic cytokine inhibitors and other interventions as per the latest guidelines). Patients randomized to the active intervention group will also receive HMW-HA (Yabro®, 5 ml of saline containing 0.3% hyaluronic acid sodium salt) via nebulizer, while patients randomized in the control group will receive a matching placebo two times daily. Due to increased risk for SARS-CoV-2 transmission via the usual mask nebulization procedure, patients will receive the nebulized treatment via high-flow oxygen tubing as described in the literature 36-38. Patients will be treated until there is a qualitative change in oxygen requirement, i.e. either progression to assisted ventilation (non-invasive or invasive), or weaning from oxygen supplementation. Because COVID19 may result in long-term O2 dependency, the study and treatment period will be limited to a maximum of 10 days. Moreover, a blood sample (20 ml) will be taken at baseline and after 10 days of treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
180
Aerolized administration b.i.d.
Università Campus Biomedico di Roma
Roma, Italy
Cumulative time on oxygen
cumulative duration of oxygen treatment
Time frame: 10 days
Need for advanced airway intervention or death due to COVID19;
need of intubation or death due to COVID19
Time frame: 10 days
Rate of change of respiratory rate;
rapidity of decrease of respiratory rate
Time frame: 10 days
Change in PaO2 /FiO2 ratio during treatment
improvement of PaO2/FiO2 ratio after 10 days of treatment
Time frame: 10 days
Time to discharge from hospital
decrease of cumulative days of hospitalization
Time frame: 10 days
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