Ignite Creation Date:
2025-12-25 @ 4:28 AM
Ignite Modification Date:
2026-02-21 @ 10:34 AM
Study NCT ID:
NCT04830020
Status:
COMPLETED
Last Update Posted:
2022-03-16
First Post:
2021-03-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of Inhaled High-molecular Weight Hyaluronan in Patients With Severe COVID19: Feasibility and Outcomes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 180}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-02-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2021-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-01', 'studyFirstSubmitDate': '2021-03-31', 'studyFirstSubmitQcDate': '2021-03-31', 'lastUpdatePostDateStruct': {'date': '2022-03-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cumulative time on oxygen', 'timeFrame': '10 days', 'description': 'cumulative duration of oxygen treatment'}], 'secondaryOutcomes': [{'measure': 'Need for advanced airway intervention or death due to COVID19;', 'timeFrame': '10 days', 'description': 'need of intubation or death due to COVID19'}, {'measure': 'Rate of change of respiratory rate;', 'timeFrame': '10 days', 'description': 'rapidity of decrease of respiratory rate'}, {'measure': 'Change in PaO2 /FiO2 ratio during treatment', 'timeFrame': '10 days', 'description': 'improvement of PaO2/FiO2 ratio after 10 days of treatment'}, {'measure': 'Time to discharge from hospital', 'timeFrame': '10 days', 'description': 'decrease of cumulative days of hospitalization'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Covid19']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nDue 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.\n\nMoreover, a blood sample (20 ml) will be taken at baseline and after 10 days of treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18\n* 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.\n* Respiratory failure requiring oxygen therapy\n* Has symptoms consistent with COVID-19, and is in non-fibroproliferative stage of disease, as determined by investigator.\n\nExclusion Criteria:\n\n* Respiratory arrest or the need for immediate intubation;\n* Upper airway obstruction;\n* Facial trauma;\n* Inability to cooperate (e.g. agitation or dementia)\n* Inability to give informed consent\n* Participation in another study for COVID19 treatments\n* Deterioration due to other reasons than progressive COVID19 pneumonia per clinical judgment, e.g. pulmonary thromboembolism, heart failure, renal failure etc.\n* Palliative care or expectation that patient will not survive \\> 72 hours post randomization per clinical judgment of the investigator.'}, 'identificationModule': {'nctId': 'NCT04830020', 'acronym': 'HA-COVID', 'briefTitle': 'Use of Inhaled High-molecular Weight Hyaluronan in Patients With Severe COVID19: Feasibility and Outcomes', 'organization': {'class': 'OTHER', 'fullName': 'Campus Bio-Medico University'}, 'officialTitle': 'Use of Inhaled High-molecular Weight Hyaluronan in Patients With Severe COVID19: Feasibility and Outcomes', 'orgStudyIdInfo': {'id': 'CampusBioMedico'}, 'secondaryIdInfos': [{'id': '1ZIDES102465', 'link': 'https://reporter.nih.gov/quickSearch/1ZIDES102465', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'HMW-HA', 'description': 'HMW-HA (Yabro - 5 ml of saline containing 0.3% hyaluronic acid sodium salt)', 'interventionNames': ['Drug: HMW-HA']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': '5 ml of saline via nebulizer b.i.d.', 'interventionNames': ['Drug: HMW-HA']}], 'interventions': [{'name': 'HMW-HA', 'type': 'DRUG', 'otherNames': ['Yabro'], 'description': 'Aerolized administration b.i.d.', 'armGroupLabels': ['HMW-HA', 'placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00128', 'city': 'Roma', 'country': 'Italy', 'facility': 'Università Campus Biomedico di Roma', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}], 'overallOfficials': [{'name': 'Raffaele Antonelli Incalzi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Università Campus-Biomedico di Roma'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Campus Bio-Medico University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Environmental Health Sciences (NIEHS)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}