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

NCT04830020 | Completed Phase 2

• 2 other identifiers: CampusBioMedico1ZIDES102465
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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 disease in hospitalized patients.

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

• Cumulative time on oxygen

  cumulative duration of oxygen treatment

  10 days

Secondary Outcomes (4)

• Need for advanced airway intervention or death due to COVID19;

  10 days

• Rate of change of respiratory rate;

  10 days

• Change in PaO2 /FiO2 ratio during treatment

  10 days

• Time to discharge from hospital

  10 days

Study Arms (2)

HMW-HA

ACTIVE COMPARATOR

HMW-HA (Yabro - 5 ml of saline containing 0.3% hyaluronic acid sodium salt)

Drug: HMW-HA

placebo

PLACEBO COMPARATOR

5 ml of saline via nebulizer b.i.d.

Drug: HMW-HA

Interventions

HMW-HA DRUG

Aerolized administration b.i.d.

Also known as: Yabro

HMW-HA; placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Campus Bio-Medico University: lead
• National Institute of Environmental Health Sciences (NIEHS): collaborator

Study Sites (1)

Università Campus Biomedico di Roma

Roma, 00128, Italy

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Raffaele Antonelli Incalzi, MD

  Università Campus-Biomedico di Roma

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2021
• First Posted: April 2, 2021
• Study Start: February 26, 2021
• Primary Completion: June 30, 2021
• Study Completion: September 30, 2021
• Last Updated: March 16, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)