ebulised heparin in COVID-19-related ARDS patients undergoing helmet non-invasive ventilatio

Phase 1

• Conditions: COVID-19-related Acute Respiratory Distress Syndrome (ARDS) patients undergoing non-invasive ventilation with helmet continuous positive airway pressure (cPAP); MedDRA version: 22.0Level: LLTClassification code 10052956Term: CPAPSystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 23.1Level: PTClassification code 10084460Term: COVID-19 treatmentSystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 21.1Level: LLTClassification code 10003083Term: ARDSSystem Organ Class: 100000004855; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-005863-29-IT
• Lead Sponsor: ASST FATEBENEFRATELLI SACCO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-08-17
• Last Update Posted: 2 March 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 160

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 < 92% and respiratory rate > 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

- 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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:<br>•need for cPAP helmet ventilation;<br>•need for mechanical ventilation;<br>•duration of mechanical ventilation (when needed);<br>•mortality during the 28 days following the beginning of cPAP <br>•safety<br>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

Secondary Outcome Measures

Name	Time	Method
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)