Status:

COMPLETED

Infusion of Prostacyclin (Iloprost) vs Placebo for 72-hours in COVID-19 Patients With Respiratory Failure

Lead Sponsor:

Pär Johansson

Conditions:

COVID-19

Respiratory Failure

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief Summary

The purpose of this trial is to investigate the efficacy and safety of continuous intravenous administration of low dose iloprost versus placebo for 72-hours, in 80 patients with COVID-19 suffering fr...

Detailed Description

Patients with the most severe type of sepsis, those with septic shock have a mortality rate between 30% to 45% due to multiple organ failure. The poor outcome of shocked patients, and especially those...

Eligibility Criteria

Inclusion

  • Adult intensive care patients (aged 18 years or above)
  • Confirmed COVID-19 infection
  • Need for mechanical ventilation (\< 72 hours at time of screening)
  • Soluble thrombomodulin (sTM) ≥ 4 ng/mL

Exclusion

  • Withdrawal from active therapy
  • 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.
  • Previously included in this trial or a prostacyclin trial within 30 days
  • Consent cannot be obtained
  • Life-threatening bleeding defined by the treating physician
  • Known severe heart failure (NYHA class IV)
  • Suspected acute coronary syndrome

Key Trial Info

Start Date :

June 15 2020

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

April 23 2021

Estimated Enrollment :

80 Patients enrolled

Trial Details

Trial ID

NCT04420741

Start Date

June 15 2020

End Date

April 23 2021

Last Update

May 7 2024

Active Locations (5)

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Page 1 of 2 (5 locations)

1

Dept. of Anaesthesia and Intensive Care, Bispebjerg Hospital

Copenhagen, Denmark

2

Dept. of Intensive Care, Copenhagen University Hospital, Rigshospitalet

Copenhagen, Denmark

3

Dept. of Intensive Care, Copenhagen University Hospital Herlev

Herlev, Denmark

4

Dept. of Anaesthesia and Intensive Care, Nordsjaelands Hospital

Hillerød, Denmark