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

Covid19 Clinical Trial

— HA-COVID  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04830020
• Other study ID #: CampusBioMedico
• Secondary ID: 1ZIDES102465
• Status: Completed
• Phase: Phase 2
• Start date: February 26, 2021
• Est. completion date: September 30, 2021

Study information

• Verified date: March 2022
• Source: Campus Bio-Medico University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: September 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

Drug:
• HMW-HA
Aerolized administration b.i.d.

Locations

Country	Name	City	State
Italy	Università Campus Biomedico di Roma	Roma

Sponsors (2)

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

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative time on oxygen	cumulative duration of oxygen treatment	10 days
Secondary	Need for advanced airway intervention or death due to COVID19;	need of intubation or death due to COVID19	10 days
Secondary	Rate of change of respiratory rate;	rapidity of decrease of respiratory rate	10 days
Secondary	Change in PaO2 /FiO2 ratio during treatment	improvement of PaO2/FiO2 ratio after 10 days of treatment	10 days
Secondary	Time to discharge from hospital	decrease of cumulative days of hospitalization	10 days