A Phase 2 interventional study of FX06 and Placebo of FX06 in Ards, Covid19 and Pneumonia, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 3 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-06-22.
Sponsored by Assistance Publique - Hôpitaux de Paris · Phase 2, Interventional, and Treatment
Vascular leakage following endothelial injury, responsible for interstitial and alveolar edema, is a major feature of pathogen induced acute lung injury. As acute respiratory distress syndrome (ARDS) due to pandemic Covid-19 is associated with more than 60% mortality, controlling vascular leakage may be a major target to decrease the mortality associated with the spreading of the disease in France.
FX06, a drug under clinical development containing fibrin-derived peptide beta15-42, is able to stabilize cell-cell interactions, thereby reducing vascular leak and mortality in several animal models, particularly during lipopolysaccharide-induced and dengue hemorrhagic shock . A phase I study was conducted in humans, with no specific adverse event detected with a dose up to 17.5 mg/kg. In a phase II randomized multicentre double-blinded trial in 234 patients suffering from ST+ acute coronary syndrome, FX06 treated patients exhibited a 58% decrease in the early necrotic core zone. Importantly, adverse events were highly comparable between groups, indicating a high safety profile for the drug . Lastly, the drug was used as a salvage therapy in a patient exhibiting a severe ARDS following EBOLA virus infection . Altogether, those data indicate that FX06 is well tolerated in humans and is a potent regulator of vascular leakage.
Our hypothesis here is that FX06 may decrease pulmonary vascular hyperpermeability during ARDS following SARS-CoV-2 infection, thereby improving gas exchanges and the outcome of infected patients.
994 studies on the registry are indexed under Acute Lung Injury; 156 are open to participants now.
This study's enrollment of 50 is below the median of 56 across 564 interventional studies indexed under Acute Lung Injury.
Browse Acute Lung Injury studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,576 studies on the registry; 1,028 are open to participants now.
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Exclusion Criteria:
Drug: FX06
Drug: Placebo of FX06
FX06 i.v.: 400 mg per day (divided in two injections) during 5 days
Placebo i.v.: 400 mg per day (divided in two injections) during 5 days
Change in extravascular lung water index (EVLWi)
Assessed by transpulmonary thermodilution Transpulmonary thermodilution systems, part of the standard management in ICU, allow a direct evaluation of vascular hyperpermeability in the lungs using thermodilution technique. EVLWi is a reliable parameter, independently associated with mortality during ARDS
Time frame: Between Day 1 and Day 7
Evolution of daily extravascular lung water index (EVLWi)
measured by transpulmonary thermodilution during 7 days
Time frame: Between Day 1 and Day 7
Evolution of daily cardiac index
measured by transpulmonary thermodilution during 7 days
Time frame: Between Day 1 and Day 7
Evolution of global end-diastolic volume index
measured by transpulmonary thermodilution during 7 days
Time frame: Between Day 1 and Day 7
Evolution of pulmonary vascular permeability index
measured by transpulmonary thermodilution during 7 days
Time frame: Between Day 1 and Day 7
Overall survival
Time frame: Day 30
Mortality rate in ICU and in hospital
Time frame: Through study completion an average of 2 months
Rate of withdraw or withhold life-sustaining treatments decision
Time frame: Day 30
Daily weight
Time frame: Between Day 1 and Day 7
Daily fluid balance
Time frame: Between Day 1 and Day 7
Evolution of albuminemia
Evolution of blood biological criteria (g/L)
Time frame: Between Day 1 and Day 7
Duration of mechanical ventilation
Time frame: Day 30
Proportion of participants alive and off invasive mechanical ventilation
Time frame: Day 30
Evolution of Murray ARDS severity score
Time frame: Day 1 to day 15
Evolution of radiological Weinberg score
Scale from 0 to 12 better with higher score indicating more severe radiological pulmonary severity
Time frame: Day 1 to Day 30
Evolution of pulmonary Sequential Organ Failure Assessment) score.
Scale from 0 to 4 betterwith higher score indicating more severe pulmonary disease
Time frame: Day 1 to day 15
Rate of rescue therapy with Veino-veinous V-ECMO
Time frame: Through study completion an average of 2 months
Evolution of SOFA (Sequential Organ Failure Assessment) score
Scale from 0 to 24, lower is better.
Time frame: Day 15
Organ failure free days
one or more SOFA sub-score \>=3
Time frame: Day 15
Renal replacement therapy free days
Time frame: Day 30
Duration of renal replacement therapy free days
Time frame: Day 30
Nature and frequency of adverse events
Time frame: Through study completion an average of 2 months
Evolution of FX06 concentration
measured at day 1 at time 0 (before FX06 application) and after 5, 15, 30, 60 min
Time frame: Day 1
Immunogenicity (antibody against FX06) induced by the drug, performed by ELISA according to manufacturer's procedure
A test for immunogenicity will be performed on a serum sample at day 7 (2 days after the end of treatment administration) to detect any antibody against FX06. The assay will consist in a three-fold procedure, as recommended by the manufacturer. An initial screening assay will qualitatively measure antibodies to FX06. Samples deemed positive will be subject to a confirmatory assay, which will determine the specificity of the detected antibody against FX06. The third tier of the assay will consist in titre analysis to semi-quantitatively assess the antibody response.
Time frame: Day 7
This study is completed, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.
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