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

Primary Purpose

Covid19

Status
Completed
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
HMW-HA
Sponsored by
Campus Bio-Medico University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Covid19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Università Campus Biomedico di Roma

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

HMW-HA

placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Cumulative time on oxygen
cumulative duration of oxygen treatment

Secondary Outcome Measures

Need for advanced airway intervention or death due to COVID19;
need of intubation or death due to COVID19
Rate of change of respiratory rate;
rapidity of decrease of respiratory rate
Change in PaO2 /FiO2 ratio during treatment
improvement of PaO2/FiO2 ratio after 10 days of treatment
Time to discharge from hospital
decrease of cumulative days of hospitalization

Full Information

First Posted
March 31, 2021
Last Updated
March 1, 2022
Sponsor
Campus Bio-Medico University
Collaborators
National Institute of Environmental Health Sciences (NIEHS)
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1. Study Identification

Unique Protocol Identification Number
NCT04830020
Brief Title
Use of Inhaled High-molecular Weight Hyaluronan in Patients With Severe COVID19: Feasibility and Outcomes
Acronym
HA-COVID
Official Title
Use of Inhaled High-molecular Weight Hyaluronan in Patients With Severe COVID19: Feasibility and Outcomes
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
February 26, 2021 (Actual)
Primary Completion Date
June 30, 2021 (Actual)
Study Completion Date
September 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Campus Bio-Medico University
Collaborators
National Institute of Environmental Health Sciences (NIEHS)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
180 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HMW-HA
Arm Type
Active Comparator
Arm Description
HMW-HA (Yabro - 5 ml of saline containing 0.3% hyaluronic acid sodium salt)
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
5 ml of saline via nebulizer b.i.d.
Intervention Type
Drug
Intervention Name(s)
HMW-HA
Other Intervention Name(s)
Yabro
Intervention Description
Aerolized administration b.i.d.
Primary Outcome Measure Information:
Title
Cumulative time on oxygen
Description
cumulative duration of oxygen treatment
Time Frame
10 days
Secondary Outcome Measure Information:
Title
Need for advanced airway intervention or death due to COVID19;
Description
need of intubation or death due to COVID19
Time Frame
10 days
Title
Rate of change of respiratory rate;
Description
rapidity of decrease of respiratory rate
Time Frame
10 days
Title
Change in PaO2 /FiO2 ratio during treatment
Description
improvement of PaO2/FiO2 ratio after 10 days of treatment
Time Frame
10 days
Title
Time to discharge from hospital
Description
decrease of cumulative days of hospitalization
Time Frame
10 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raffaele Antonelli Incalzi, MD
Organizational Affiliation
Università Campus-Biomedico di Roma
Official's Role
Principal Investigator
Facility Information:
Facility Name
Università Campus Biomedico di Roma
City
Roma
ZIP/Postal Code
00128
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No

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

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