Nebulised heparin in COVID-19-related ARDS patients undergoing helmet non-invasive ventilation

Nebulised heparin in COVID-19-related ARDS patients undergoing non-invasive ventilation with helmet cPAP: a prospective, randomised, double blind, placebo-controlled, multicentre study - HelmetHeparin

Status

Not yet recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-005863-29-IT

Enrollment

160

Registered

2021-08-17

Start date

2021-07-15

Completion date

Unknown

Last updated

2022-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19-related Acute Respiratory Distress Syndrome (ARDS) patients undergoing non-invasive ventilation with helmet continuous positive airway pressure (cPAP) MedDRA version: 22.0 Level: LLT Classification code 10052956 Term: CPAP System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 23.1 Level: PT Classification code 10084460 Term: COVID-19 treatment System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 21.1 Level: LLT Classification code 10

Interventions

Trade Name: VERACER - 25000 U.I./5ML SOLUZIONE INIETTABILE 10 FIALE Product Name: Eparina sodica 25.000 UI/5 ml (VERACER) Product Code: [033344021] Pharmaceutical Form: Solution for injection INN or P

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Age 18 years or older; - Positive molecular COVID-19 test on nasopharyngeal swab; - Interstitial pneumonia confirmed on lung CT scan; - Indication to helmet cPAP according to the COVID-19 Treatment Guideline criteria (21), i.e. the presence of at least one of the following signs during O2 therapy with O2 mask reservoir-bag 15 L/min: SpO2 26/min and/or evident respiratory distress (point 5 on the WHO ordinal scale). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 65 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 95

Exclusion criteria

Exclusion criteria: - Age 80 years or older; - Ongoing anticoagulant therapy; - Clinically not compatible with helmet cPAP interruption for 10-25 minutes 4 times a day; - Home cPAP treatment; - Home O2 therapy; - Insulin-dependent diabetes mellitus - Acute myocardial infarction during the previous 6 months; - Ongoing oncological disease; - Chronic renal failure; - CT scan diagnosis of pulmonary thromboembolism; - Body Mass Index (BMI) over 40; - Uncontrolled bleeding; - Not able to understand or sign the informed consent.

Design outcomes

Primary

Measure	Time frame
Main Objective: Assess the effect of 25,000 IU Q4 of nebulised unfractionated heparin (UFH) in COVID-19 patients undergoing non-invasive cPAP helmet ventilation in terms of reducing cPAP use.;Secondary Objective: Assess the effect of 25,000 IU Q4 nebulised UFH in terms of: • need for cPAP helmet ventilation; • need for mechanical ventilation; • duration of mechanical ventilation (when needed); • mortality during the 28 days following the beginning of cPAP • safety in patients undergoing non-invasive cPAP helmet ventilation for COVID-19 pneumonia.;Primary end point(s): The primary endpoint is the number of days of cPAP use in COVID-19 patients undergoing non-invasive cPAP helmet ventilation who neither die nor undergo mechanical ventilation.;Timepoint(s) of evaluation of this end point: 10 days from randomisation	—

Measure

Time frame

Main Objective: Assess the effect of 25,000 IU Q4 of nebulised unfractionated heparin (UFH) in COVID-19 patients undergoing non-invasive cPAP helmet ventilation in terms of reducing cPAP use.;Secondary Objective: Assess the effect of 25,000 IU Q4 nebulised UFH in terms of: • need for cPAP helmet ventilation; • need for mechanical ventilation; • duration of mechanical ventilation (when needed); • mortality during the 28 days following the beginning of cPAP • safety in patients undergoing non-invasive cPAP helmet ventilation for COVID-19 pneumonia.;Primary end point(s): The primary endpoint is the number of days of cPAP use in COVID-19 patients undergoing non-invasive cPAP helmet ventilation who neither die nor undergo mechanical ventilation.;Timepoint(s) of evaluation of this end point: 10 days from randomisation

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Secondary

Measure	Time frame
Secondary end point(s): Proportion of patients requiring removal of cPAP helmet ventilation (point 4, 3, 2, 1 on the WHO ordinal scale) within 10 days from randomisation; Proportion of patients requiring invasive mechanical ventilation (point 6-7 on the WHO ordinal scale) within 10 days from randomisation; Number of days of mechanical ventilation (if necessary); Proportion of patients who die within 28 days following the beginning of cPAP (point 8 on the WHO ordinal scale); Daily ratio of partial pressure of oxygen to FiO2 (PaO2/FiO2); Number and type of adverse reactions;Timepoint(s) of evaluation of this end point: 10 days; 10 days; 10 days; 28 giorni; 10 days; 28 days (+10)	—

Measure

Time frame

Secondary end point(s): Proportion of patients requiring removal of cPAP helmet ventilation (point 4, 3, 2, 1 on the WHO ordinal scale) within 10 days from randomisation; Proportion of patients requiring invasive mechanical ventilation (point 6-7 on the WHO ordinal scale) within 10 days from randomisation; Number of days of mechanical ventilation (if necessary); Proportion of patients who die within 28 days following the beginning of cPAP (point 8 on the WHO ordinal scale); Daily ratio of partial pressure of oxygen to FiO2 (PaO2/FiO2); Number and type of adverse reactions;Timepoint(s) of evaluation of this end point: 10 days; 10 days; 10 days; 28 giorni; 10 days; 28 days (+10)

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Countries

Italy

Contacts

Public ContactSophia Campbell Davies

Fatebenefratelli e Oftalmico Hospital

sophia.campbell@asst-fbf-sacco.it

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026