NCT04445246

Brief Summary

Acute respiratory distress syndrome (ARDS) is a type of respiratory failure characterized by the rapid onset of widespread inflammation in the lungs. ARDS is thought to be the main cause of respiratory failure in COVID-19 patients. Research is still ongoing to further elucidate the different ARDS subtypes that may exist in COVID-19. It is crucial to find new targets for treatment and support of COVID-19 patients with respiratory failure.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at below P25 for phase_2 covid19

Timeline
Completed

Started May 2020

Typical duration for phase_2 covid19

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 23, 2020

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

June 9, 2020

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 24, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2021

Completed
Last Updated

March 29, 2022

Status Verified

May 1, 2020

Enrollment Period

1 year

First QC Date

June 9, 2020

Last Update Submit

March 26, 2022

Conditions

Keywords

Iloprostprostacyclinsinhaled nitric oxidepulmonary vasodilators

Outcome Measures

Primary Outcomes (1)

  • change in oxygenation parameters

    change in oxygen saturation and PaO2/FiO2 ratio by 20% on day 6 compared to baseline values prior to Iloprost initiation.

    5 days

Secondary Outcomes (7)

  • Rates of endotracheal intubation

    28 days

  • Invasive ventilation duration

    28 days

  • ICU length of stay

    28 days

  • Hospital Length of stay

    28 days

  • Rates of proning therapy

    28 days

  • +2 more secondary outcomes

Study Arms (1)

Inhaled Iloprost therapy

EXPERIMENTAL

Inhaled Iloprost 20 mcg every 8 hours for 5 days only delivered by nebulization

Drug: Inhaled ILOPROST

Interventions

Inhaled Iloprost 20 mcg every 8 hours for 5 days only delivered by nebulization.

Also known as: Ventavis by Actelion Pharmaceuticals US, Inc.
Inhaled Iloprost therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Suspected or confirmed COVID-19 patient by PCR
  • O2 saturation =\<92% on 5 or more l/min of O2 by NC or Face mask
  • On CPAP, HFNC or Invasive ventilation
  • Enrollment within 48h of onset of hypoxemia

You may not qualify if:

  • Age \<18
  • Pregnancy or Positive pregnancy test at the time of screening
  • Clinical evidence of left atrial hypertension or known chronic CHF
  • Persistent Hypotension SBP\<85 on presentation
  • Mechanical ventilation \>7 days
  • Patients who received iloprost treatment for any indication within 48 hours prior to enrollment in the clinical trial or patients who were on thrombin inhibitors, or nitric oxide within the previous 24 h before study randomization are also excluded.
  • Patients with contraindication for ilioprost

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hamad Medical Corporation

Doha, Qatar

Location

Related Publications (1)

  • Mulia EPB, Luke K. Inhaled prostacyclin analogues in COVID-19 associated acute respiratory distress syndrome: scientific rationale. Egypt Heart J. 2021 Sep 16;73(1):82. doi: 10.1186/s43044-021-00208-y.

MeSH Terms

Conditions

COVID-19Respiratory Distress SyndromeRespiratory Insufficiency

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesRespiration Disorders

Study Officials

  • Nadir Kharma, MD

    Hamad Medical Corporation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 9, 2020

First Posted

June 24, 2020

Study Start

May 23, 2020

Primary Completion

May 31, 2021

Study Completion

May 31, 2021

Last Updated

March 29, 2022

Record last verified: 2020-05

Locations