Efficacy and safety of 72-hour infusion of Prostacyclin (1 ng/kg/min) in patients with COVID-19 induced respiratory failure – a multicentre randomized, placebo-controlled, blinded, investigator-initiated trial

Phase 1

• Conditions: COVID-19 induced respiratory failure; MedDRA version: 20.0Level: LLTClassification code 10038696Term: Respiratory failure (excl neonatal)System Organ Class: 100000004855; MedDRA version: 20.0Level: LLTClassification code 10040050Term: Sepsis NOSSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2020-001296-33-DK
• Lead Sponsor: Section for Transfusion Medicine, Capital Region Blood bank, Copenhagen University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-04-03
• Last Update Posted: 2 June 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Adult intensive care patients (aged 18 years or above)
Confirmed COVID-19 infection
Need for mechanical ventilation (< 72 hours)
Endothelial biomarker (sTM) = 4 ng/mL

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 25
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 55

Exclusion Criteria

Pregnancy (non-pregnancy confirmed by patient being postmenopausal (age 60 or above) or having a negative urine- or plasma-hCG)
Known hypersensitivity to iloprost or to any of the other ingredients.
Consent cannot be obtained
Previously included in this trial or a prostacyclin trial within 30 days
Withdrawal from active therapy
Life-threatening bleeding defined by the treating physician
Known severe heart failure (NYHA class IV)
Suspected acute coronary syndrome

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective is to investigate whether continuous infusion of iloprost at a dose of 1 ng/kg/min for 72-hours reduces the severity of respiratory failure in the ICU as compared to placebo.;Secondary Objective: Not applicable;Primary end point(s): Days alive without mechanical ventilation in the ICU at day 28;Timepoint(s) of evaluation of this end point: Day 28

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 28- and 90-day mortality<br>Mean daily modified Sequential Organ Failure Assessment (SOFA) score in the ICU up to day 90<br>Days alive without vasopressor in the ICU at day 28 and day 90<br>Days alive without renal replacement in the ICU at day 28 and day 90<br>Days alive without mechanical ventilation in the ICU at day 90<br>Numbers of serious adverse reactions within the first 7 days<br>Numbers of serious adverse events within the first 7 days<br>;Timepoint(s) of evaluation of this end point: day 7, day 28 and day 90