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

NCT ID: NCT04830020

Last Updated: 2022-03-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-26
• Study Completion Date: 2021-09-30

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.

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 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.

Conditions

Covid19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

HMW-HA

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

Group Type: ACTIVE_COMPARATOR

HMW-HA

Intervention Type: DRUG

Aerolized administration b.i.d.

placebo

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

Group Type: PLACEBO_COMPARATOR

HMW-HA

Intervention Type: DRUG

Aerolized administration b.i.d.

Interventions

HMW-HA

Aerolized administration b.i.d.

Intervention Type: DRUG

Other Intervention Names

Yabro

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Environmental Health Sciences (NIEHS)

NIH

Sponsor Role: collaborator

Campus Bio-Medico University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Raffaele Antonelli Incalzi, MD

Role: PRINCIPAL_INVESTIGATOR

Università Campus-Biomedico di Roma

Locations

Università Campus Biomedico di Roma

Roma, , Italy

Countries

Italy

Other Identifiers

1ZIDES102465

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CampusBioMedico

Identifier Type: -

Identifier Source: org_study_id