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ArdsPhase 2FX-COVIDNCT04618042

FX06 to Rescue Acute Respiratory Distress Syndrome During Covid-19 Pneumonia

A Phase 2 study testing FX06 in people with Ards and Covid19, run by Assistance Publique - Hôpitaux de Paris at 3 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Ards, Covid19, Pneumonia
What is being tested?
FX06
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
50 participants
Where
3 sitesFrance
Study dates
13 Nov 2020to 13 Jun 2021
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 years
  • SARS-CoV-2 induced pneumonia confirmed by a positive PCR test in nasopharyngeal swab or respiratory tract secretions and ≤ 85 years
  • Acute respiratory distress syndrome (ARDS) according to Berlin criteria (bilateral pulmonary infiltrates on frontal chest x-ray, PaO2/FiO2 ratio ≤300 mmHg, objective assessment excluding hydrostatic pulmonary edema)
  • Need for endotracheal intubation and mechanical ventilation
  • Informed consent by patient or legal representative. According to the specifications of emergency consent, randomization without the close relative or surrogate consent could be performed.
  • Affiliated to a social security system
  • Highly effective method of contraception and negative highly sensitive pregnancy test, for women of childbearing potential

Who cannot join

  • Mechanically ventilation for more than 4 days
  • Patient receiving drugs interfering with inflammation: Non-steroidal anti-inflammatory drugs, immunoglobulins.
  • Patients receiving chemotherapy, radiotherapy or immunotherapy for malignancy
  • Participation in another interventional clinical trial
  • Pregnant or lactating women
  • Patient moribund on the day of randomization, defined by a SAPS-II score>90
Show all 12Show fewer
  • Contra-indication for vascular access implantation for transpulmonary thermodilution monitoring
  • Severe or terminal renal insufficiency (creatinine clearance <30 ml/min)
  • Severe hepatic insufficiency (hepatic SOFA score>2)
  • Severe cardiac insufficiency, with left ventricular ejection fraction<30%
  • Any history of severe allergic drug reaction (anaphylactic shock or allergic angioedema)
  • Persons deprived of their liberty by a judicial or administrative decision (guardianship or tutelage measure)

Trial locations and contacts

3 sites in 1 country.

France3 sites

  • Service de Médecine Intensive Réanimation - CHU Angers

    Angers, 49933

  • Service de Médecine Intensive Réanimation - CHI de Poissy

    Chambourcy, 78240

  • Hôpital Pitié Salpêtrière

    Paris, 75013

Other trials in France

About this study

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.

Conditions
Ards, Covid19, Pneumonia
Being tested
FX06, Placebo of FX06
Keywords
FX06, Pulmonary vascular hyperpermeability
Medical subject headings
Acute Lung Injury, COVID-19, Pneumonia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FX06Drug

    FX06 i.v.: 400 mg per day (divided in two injections) during 5 days

  • Placebo of FX06Drug

    Placebo i.v.: 400 mg per day (divided in two injections) during 5 days

Study groups in NCT04618042
Study groupRoleWhat they receive
FX06ExperimentalNot described
Receives: Drug: FX06
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo of FX06

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Between Day 1 and Day 7

Secondary outcomes (23)

  1. Evolution of daily extravascular lung water index (EVLWi)

    measured by transpulmonary thermodilution during 7 days

    Measured: Between Day 1 and Day 7

  2. Evolution of daily cardiac index

    measured by transpulmonary thermodilution during 7 days

    Measured: Between Day 1 and Day 7

  3. Evolution of global end-diastolic volume index

    measured by transpulmonary thermodilution during 7 days

    Measured: Between Day 1 and Day 7

  4. Evolution of pulmonary vascular permeability index

    measured by transpulmonary thermodilution during 7 days

    Measured: Between Day 1 and Day 7

  5. Overall survival

    Measured: Day 30

  6. Mortality rate in ICU and in hospital

    Measured: Through study completion an average of 2 months

  7. Rate of withdraw or withhold life-sustaining treatments decision

    Measured: Day 30

  8. Daily weight

    Measured: Between Day 1 and Day 7

  9. Daily fluid balance

    Measured: Between Day 1 and Day 7

  10. Evolution of albuminemia

    Evolution of blood biological criteria (g/L)

    Measured: Between Day 1 and Day 7

  11. Duration of mechanical ventilation

    Measured: Day 30

  12. Proportion of participants alive and off invasive mechanical ventilation

    Measured: Day 30

  13. Evolution of Murray ARDS severity score

    Measured: Day 1 to day 15

  14. Evolution of radiological Weinberg score

    Scale from 0 to 12 better with higher score indicating more severe radiological pulmonary severity

    Measured: Day 1 to Day 30

  15. Evolution of pulmonary Sequential Organ Failure Assessment) score.

    Scale from 0 to 4 betterwith higher score indicating more severe pulmonary disease

    Measured: Day 1 to day 15

  16. Rate of rescue therapy with Veino-veinous V-ECMO

    Measured: Through study completion an average of 2 months

  17. Evolution of SOFA (Sequential Organ Failure Assessment) score

    Scale from 0 to 24, lower is better.

    Measured: Day 15

  18. Organ failure free days

    one or more SOFA sub-score >=3

    Measured: Day 15

  19. Renal replacement therapy free days

    Measured: Day 30

  20. Duration of renal replacement therapy free days

    Measured: Day 30

  21. Nature and frequency of adverse events

    Measured: Through study completion an average of 2 months

  22. Evolution of FX06 concentration

    measured at day 1 at time 0 (before FX06 application) and after 5, 15, 30, 60 min

    Measured: Day 1

  23. 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.

    Measured: Day 7

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Nov 2020
  2. Study start13 Nov 2020
  3. Primary completion14 May 2021
  4. Study completion13 Jun 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04618042
Sponsor's protocol ID
APHP200495
Other IDs
2020-002056-20
Acronym
FX-COVID
Status last verified
Jun 2021
First submitted
23 Oct 2020
Last updated
22 Jun 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Guerin E, Belin L, Franchineau G, Le Guennec L, Hajage D, Diallo MH, Frapard T, Le Fevre L, Luyt CE, Combes A, Germain S, Hayon J, Asfar P, Brechot N. FX06 to rescue SARS-CoV-2-induced acute respiratory distress syndrome: a randomized clinical trial. Crit Care. 2023 Aug 29;27(1):331. doi: 10.1186/s13054-023-04616-1.

    PubMed 37641136

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing FX06 in people with Ards and Covid19, run by Assistance Publique - Hôpitaux de Paris at 3 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in extravascular lung water index (EVLWi) (time frame: Between Day 1 and Day 7). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04618042, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2021.

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