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Glenzocimab in SARS-Cov-2 Acute Respiratory DistrEss syNdrome Related to COVID-19 (GARDEN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04659109
Recruitment Status : Completed
First Posted : December 9, 2020
Last Update Posted : September 13, 2021
Sponsor:
Information provided by (Responsible Party):
Acticor Biotech

Study Description
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Brief Summary:
A randomized, double blind, multicenter, placebo-controlled, parallel group, fixed dose, phase II study to evaluate the efficacy and safety of glenzocimab in ARDS.

Condition or disease Intervention/treatment Phase
SARS-CoV Infection Acute Respiratory Distress Syndrome COVID-19 ARDS Drug: glenzocimab Drug: Placebo Phase 2

Detailed Description:

This randomized, double blind, multicenter, placebo-controlled, parallel group, fixed dose, phase II study evaluates the efficacy and safety of glenzocimab in ARDS.

Patients will be screened for eligibility and all tests should have results prior to any randomization, so as to avoid screening failures to a maximum extent. The turn-around time for these tests should be comprised within 24hrs to allow for rapid inclusions if needed. Eligible patients (n=68) will be randomized in a 1:1 ratio to glenzocimab or placebo. Patient inclusions will be fractioned into sequential (3-day apart) cohorts of growing size (2, 4 then 6 patients), each balanced between glenzocimab and placebo in order to check safety in a gradual manner. A Data Safety Monitoring Board (DSMB) will meet after 12 patients will have been accrued, and again after the first 30 patients.

Glenzocimab will be administered by IV infusion. The dosing regimen will be 1000mg for 3 days. All patients will receive in parallel the best medical care at the discretion of the investigating center, or per local guidelines. The allocation of each patient in any given center to an active treatment or placebo will strictly follow a central randomization scheme. The study period will be of a maximum of 40 days per patient. Patients will be closely monitored during the first 7 days following randomization with complete evaluations being performed at 24 hrs, 48 hrs, 72 hrs, then on Days 4 (96 hrs), 5 (120 hrs), 7 (+/-1 day), 14 (+/-2 days), 20 (+/-2 days), 40 (+/-3 days). Should a patient being discharged before Day 40, distant consultations by telemedicine may be undertaken if it is not deemed desirable that the patient comes back to the institution.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A randomized, double blind, multicenter, placebo-controlled, parallel group, fixed dose, phase II study. The study evaluates the efficacy and safety of glenzocimab.
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double Blind, Multicenter, Placebo Controlled, Parallel Group, Exploratory Efficacy and Safety Study of Glenzocimab in SARS-Cov-2-related Acute Respiratory Distress Syndrome
Actual Study Start Date : December 16, 2020
Actual Primary Completion Date : August 6, 2021
Actual Study Completion Date : August 6, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: glenzocimab 1000 mg Drug: glenzocimab
IV administration as a sterile product
Other Name: ACT017
Placebo Comparator: Placebo Drug: Placebo
IV administration


Outcome Measures
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Primary Outcome Measures :
  1. Progression from moderate to severe respiratory distress assessed at Day 4 [ Time Frame: Day 4 ]

    Progression from moderate to severe assessed at Day 4 is a composite failure endpoint defined as the occurrence of at least one of the following failure events :

    • Respiratory rate (RR) ≥ 30/min, or
    • Oxygen Saturation (SpO2) ≤ 93% in resting state, or
    • Oxygen Pressure/ Inspired fraction (PaO2/FiO2) ≤ 200mmHg
    • Death occurring prior to or on Day 4


Secondary Outcome Measures :
  1. All cause mortality at day 40 [ Time Frame: Day 40 (maximum) ]
  2. WHO-COVID-19 Scale [ Time Frame: Up to Day 40 ]
    WHO COVID-19 Ordinal Scoring Scale is 9 point ordinal scale

  3. NEWS-2 Scale [ Time Frame: Up to Day 40 ]
    Determines the degree of illness of a patient and prompts critical care intervention (recommended by NHS over original NEWS): total possible score ranges from 0 to 20. The higher the scores the greater the clinical risk.

  4. Respiratory Rate status (RR) [ Time Frame: Up to Day 40 ]

    Respiratory Rate status defined as:: o Normal:<20/min,

    • Mild:20/min≤RR<24/min,
    • Moderate:24/min≤RR<30/min, o Severe:≥30/min,
    • Death.

  5. Hypoxemia status [ Time Frame: Up to Day 40 ]

    Hypoxemia status defined as:: o Normal:>300mmHg,

    • Mild: 200 mmHg < PaO2/FiO2 ≤ 300 mmHg,
    • Moderate:100mmHg<PaO2/FIO2≤200mmHg, o Severe:PaO2/FIO2≤100mmHg,
    • Death.

  6. SpO2 status [ Time Frame: Up to Day 40 ]

    SpO2 status defined as: o Normal:>95%

    • Mild:93%<SpO2≤95%,
    • Moderate:90%<SpO2≤93%, o Severe:≤90%,
    • Death.

  7. CHEST CT-Scan (or in exceptional cases, chest radiogram) [ Time Frame: Day 4 ]
  8. Oxygen-free days [ Time Frame: Up to Day 40 ]
  9. Admission to the ICU [ Time Frame: Up to Day 40 ]
  10. ICU-free days [ Time Frame: Up to Day 40 ]
  11. Hospital-free days [ Time Frame: Up to Day 40 ]
  12. Clinical recovery and Time to Clinical recovery [ Time Frame: Up to Day 40 ]
  13. Cure and Time-to-cure [ Time Frame: Up to Day 40 ]
  14. Incidence, nature and severity of Adverse Events, SAEs, SUSARs and Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: Up to Day 40 ]
  15. Incidence of bleeding-related events [ Time Frame: Up to Day 40 ]
  16. Incidence of hypersensitivity reactions [ Time Frame: Up to Day 40 ]
  17. Changes from baseline on blood pressure [ Time Frame: Up to Day 40 ]
  18. Changes from baseline on heart rate [ Time Frame: Up to Day 40 ]
  19. Changes from baseline on NFS [ Time Frame: Up to Day 40 ]
  20. Changes from baseline on INR/PTT [ Time Frame: Up to Day 40 ]
  21. Changes from baseline on platelet count [ Time Frame: Up to Day 40 ]
  22. Changes from baseline on plasma fibrinogen level [ Time Frame: Up to Day 40 ]
  23. Changes from baseline on plasma D-Dimers level [ Time Frame: Up to Day 40 ]
  24. Changes from baseline on serum-glucose level [ Time Frame: Up to Day 40 ]
  25. Changes from baseline on urea level [ Time Frame: Up to Day 40 ]
  26. Changes from baseline on creatinemia [ Time Frame: Up to Day 40 ]
  27. Changes from baseline on LFTs (ASAT/ALAT) [ Time Frame: Up to Day 40 ]
  28. Changes from baseline on CRP level [ Time Frame: Up to Day 40 ]
  29. Changes from baseline on LDH level [ Time Frame: Up to Day 40 ]
  30. Changes from baseline on IL6 level [ Time Frame: Up to Day 40 ]
  31. Changes from baseline on Tnt [ Time Frame: Up to Day 40 ]
  32. Changes from baseline on NT proBNP [ Time Frame: Up to Day 40 ]
  33. Changes from baseline on procalcitonin level [ Time Frame: Up to Day 40 ]
  34. Changes from baseline on ferritin level [ Time Frame: Up to Day 40 ]
  35. ECG over the course of the study versus screening [ Time Frame: Up to Day 40 ]
    Changes in one or several of the usual ECG parameters compared to baseline or screening, i.e. sinusal rhythm, cardiac axis, QRS value, QT/QTc segment, Wave direction, and any abnormality.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female hospitalized patients ≥ 18 years (i.e., at least 18 years old at the time of randomization), having given their written consent.
  2. Having a positive RT-PCR test for COVID-19

  3. Presenting with symptoms of COVID-19, including:

    • Cough OR
    • Shortness of breath or difficulty breathing OR at least 2 of the following
    • Fever, defined as any body temperature 38°C
    • Chills
    • Repeated shaking with chills
    • Muscle pain
    • Headache
    • Sore throat
    • New loss of taste or smell

  4. Presenting with signs of moderate but progressive pulmonary disease with:

    • respiratory symptoms (cough, dyspnea, etc.),
    • uni- or bilateral ground-glass opacities, or pulmonary infiltrates on chest radiograph and/or CT scan,
    • clinical and biological evidence of progression over the past 48hrs.

  5. Effective birth control that should have been in place for at least 2 months in non-menopausal women and 4 months for men after IMP administration. Birth control methods considered to be highly effective include:

    • combined (estrogen-progestogen) hormonal contraception associated with the inhibition of ovulation: oral, intravaginal, transdermal,
    • progesterone-only hormonal contraception associated with the inhibition of ovulation: oral, injectable, implantable,
    • intrauterine device,
    • intrauterine hormone-releasing system,
    • bilateral tubal occlusion,
    • vasectomized partner.
  6. Women of child-bearing potential must have negative results of a urinary or plasma pregnancy test (serum HCG).

Exclusion Criteria:

  1. Patients requiring immediate admission to the ICU,
  2. Patients requiring invasive mechanical ventilation,
  3. ARDS of another origin,
  4. Concomitant pulmonary infection (pneumoniae) with another agent, notably bacterial or fungal,
  5. Patients under immunosuppressive agents,
  6. Childbirth within <10 days,
  7. Pregnancy or breastfeeding,
  8. Prior cardiopulmonary resuscitation <10 days,
  9. Allergy or hypersensitivity to drugs of the same class
  10. Participation in another interventional clinical trial within 30 days prior to the inclusion.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04659109


Locations
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France
Hôpital de Hautepierre
Strasbourg, France, 67091
Sponsors and Collaborators
Acticor Biotech
More Information
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Publications:

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Responsible Party: Acticor Biotech
ClinicalTrials.gov Identifier: NCT04659109    
Other Study ID Numbers: ACT-CS-006
2020-002733-15 ( EudraCT Number )
First Posted: December 9, 2020    Key Record Dates
Last Update Posted: September 13, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Acticor Biotech:
Covid 19
ARDS
SARS-Cov
glenzocimab
 Acute Respiratory Distress Syndrome
ACT017
glycoprotein VI
antiplatelet agent
Additional relevant MeSH terms:
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COVID-19
Severe Acute Respiratory Syndrome
Respiratory Distress Syndrome
Respiratory Distress Syndrome, Newborn
Acute Lung Injury
Syndrome
Disease
Pathologic Processes
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Infections
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury
Glenzocimab
Anticoagulants