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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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