Use of Inhaled High-molecular Weight Hyaluronan in Patients With Severe COVID19: Feasibility and Outcomes

• Status: Recruiting
• Trial end date: 2021-08-31
• Target enrollment: 0
• Participant gender: All

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 disease in hospitalized patients.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Campus Bio-Medico University
• Collaborator: National Institute of Environmental Health Sciences (NIEHS)

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.