Status:
COMPLETED
Use of Inhaled High-molecular Weight Hyaluronan in Patients With Severe COVID19: Feasibility and Outcomes
Lead Sponsor:
Campus Bio-Medico University
Collaborating Sponsors:
National Institute of Environmental Health Sciences (NIEHS)
Conditions:
Covid19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 ...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- Age ≥ 18
- Diagnosis of COVID19 by validated SARS-CoV-2 antigen, RT-PCR, or other molecular diagnostic assay, using an appropriate sample such as NP, nasal, oropharyngeal \[OP\], or saliva) and no alternative explanation for current clinical condition.
- Respiratory failure requiring oxygen therapy
- Has symptoms consistent with COVID-19, and is in non-fibroproliferative stage of disease, as determined by investigator.
Exclusion
- Respiratory arrest or the need for immediate intubation;
- Upper airway obstruction;
- Facial trauma;
- Inability to cooperate (e.g. agitation or dementia)
- Inability to give informed consent
- Participation in another study for COVID19 treatments
- Deterioration due to other reasons than progressive COVID19 pneumonia per clinical judgment, e.g. pulmonary thromboembolism, heart failure, renal failure etc.
- Palliative care or expectation that patient will not survive \> 72 hours post randomization per clinical judgment of the investigator.
Key Trial Info
Start Date :
February 26 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2021
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT04830020
Start Date
February 26 2021
End Date
September 30 2021
Last Update
March 16 2022
Active Locations (1)
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1
Università Campus Biomedico di Roma
Roma, Italy, 00128