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

NCT04420741 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2024-05-07

No results posted yet for this study

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 from respiratory failure. The study hypothesis is that iloprost may be beneficial as an endothelial rescue treatment as it is anticipated to deactivate the endothelium and restore vascular integrity in COVID-19 patients suffering from respiratory failure caused by endothelial breakdown, ultimately improving survival. Given that the pulmonary system, apart from the brain, is the most highly vascularized vital organ in the body, extensive endothelial damage is a central feature of acute respiratory distress syndrome (ARDS) with respiratory failure being the rationale for the current study COMBAT-COVID-19.

Conditions

Interventions

DRUG

Iloprost

Continuously infusion for 72 hours at 3 ml/hours. Treatment dose 1 ng/kg/min

DRUG

Isotonic saline

Continuously infusion for 72 hours at 3 ml/hours

Sponsors & Collaborators

  • Pär Johansson

    lead OTHER

Principal Investigators

  • Anders Perner, MD, PhD · Copenhagen University Hospital, Intensive care Unit 4131

  • Pär I Johansson, MD, DMSc · Copenhagen University Hospital, Capital Blood Bank 2034

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-15
Primary Completion
2021-02-23
Completion
2021-04-23

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04420741 on ClinicalTrials.gov