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Plerixafor in Acute Respiratory Distress Syndrome Related to COVID-19 (Phase IIb)

NCT05411575 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2023-04-10

No results posted yet for this study

Summary

This phase IIb study, LEONARDO is a multicenter, randomized, double-blind, placebo- controlled, parallel group study, to assess the therapeutic efficacy and safety of Plerixafor in patients over 18 years of age,

* with acute respiratory failure related to COVID-19 and
* Recently admitted in ICU or equivalent structure (within 48 hours) for COVID-19 related respiratory failure
* without invasive mechanical ventilation and
* requiring oxygen support ≥ 5L/min to obtain a transcutaneous O2 saturation \> 94% A total of 150 participants, will be randomized in a 2:1 ratio to receive either Plerixafor (n=100) or placebo (n=50) as a continuous IV infusion for 7 days (from D1 to D8) in addition to standard of care (e.g. glucocorticoids...).

Safety data will be reviewed by an independent Data and Safety Monitoring Board (DSMB) during the study.

Conditions

  • COVID-19 Acute Respiratory Distress Syndrome
  • COVID-19

Interventions

DRUG

Plerixafor 20 MG/ML [Mozobil]

Plerixafor (Mozobil®) continuous intravenous infusion for 7 days

OTHER

Placebo

Placebo continuous intravenous infusion for 7 days

Sponsors & Collaborators

  • 4Living Biotech

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-19
Primary Completion
2022-10-31
Completion
2022-10-31

Countries

  • Bulgaria
  • France

Study Locations

More Related Trials

Entities

Diseases

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 NCT05411575 on ClinicalTrials.gov