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SARS-CoV InfectionPhase 2GARDENNCT04659109

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

A Phase 2 study testing glenzocimab in people with SARS-CoV Infection and Acute Respiratory Distress Syndrome, run by Acticor Biotech at 1 site 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

A randomized, double blind, multicenter, placebo-controlled, parallel group, fixed dose, phase II study to evaluate the efficacy and safety of glenzocimab in ARDS. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
glenzocimab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
1 siteFrance
Study dates
16 Dec 2020to 6 Aug 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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female hospitalized patients ≥ 18 years (i.e., at least 18 years old at the time of randomization), having given their written consent.
  • Having a positive RT-PCR test for COVID-19
  • 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
Show all 24Show fewer
  • Chills
  • Repeated shaking with chills
  • Muscle pain
  • Headache
  • Sore throat
  • New loss of taste or smell
  • 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.
  • 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.
  • Women of child-bearing potential must have negative results of a urinary or plasma pregnancy test (serum HCG).

Who cannot join

  • Patients requiring immediate admission to the ICU,
  • Patients requiring invasive mechanical ventilation,
  • ARDS of another origin,
  • Concomitant pulmonary infection (pneumoniae) with another agent, notably bacterial or fungal,
  • Patients under immunosuppressive agents,
  • Childbirth within <10 days,
Show all 10Show fewer
  • Pregnancy or breastfeeding,
  • Prior cardiopulmonary resuscitation <10 days,
  • Allergy or hypersensitivity to drugs of the same class
  • Participation in another interventional clinical trial within 30 days prior to the inclusion.

Trial locations and contacts

1 site in 1 country.

France1 site

  • Hôpital de Hautepierre

    Strasbourg, 67091

Other trials in France

About this study

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

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

Read the 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.

Being tested
glenzocimab, Placebo
Keywords
Covid 19, ARDS, SARS-Cov, glenzocimab, Acute Respiratory Distress Syndrome, ACT017, glycoprotein VI, antiplatelet agent
Medical subject headings
Severe Acute Respiratory Syndrome, Respiratory Distress Syndrome, COVID-19

What participants receive

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

  • glenzocimabDrug

    Also called ACT017

    IV administration as a sterile product

  • PlaceboDrug

    IV administration

Study groups in NCT04659109
Study groupRoleWhat they receive
glenzocimab 1000 mgExperimentalNot described
Receives: Drug: glenzocimab
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

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

  1. Progression from moderate to severe respiratory distress assessed at 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

    Measured: Day 4

Secondary outcomes (35)

  1. All cause mortality at day 40

    Measured: Day 40 (maximum)

  2. WHO-COVID-19 Scale

    WHO COVID-19 Ordinal Scoring Scale is 9 point ordinal scale

    Measured: Up to Day 40

  3. NEWS-2 Scale

    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.

    Measured: Up to Day 40

  4. Respiratory Rate status (RR)

    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.

    Measured: Up to Day 40

  5. Hypoxemia status

    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.

    Measured: Up to Day 40

  6. SpO2 status

    SpO2 status defined as: o Normal:>95%

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

    Measured: Up to Day 40

  7. CHEST CT-Scan (or in exceptional cases, chest radiogram)

    Measured: Day 4

  8. Oxygen-free days

    Measured: Up to Day 40

  9. Admission to the ICU

    Measured: Up to Day 40

  10. ICU-free days

    Measured: Up to Day 40

  11. Hospital-free days

    Measured: Up to Day 40

  12. Clinical recovery and Time to Clinical recovery

    Measured: Up to Day 40

  13. Cure and Time-to-cure

    Measured: Up to Day 40

  14. Incidence, nature and severity of Adverse Events, SAEs, SUSARs and Treatment-Emergent Adverse Events (TEAEs)

    Measured: Up to Day 40

  15. Incidence of bleeding-related events

    Measured: Up to Day 40

  16. Incidence of hypersensitivity reactions

    Measured: Up to Day 40

  17. Changes from baseline on blood pressure

    Measured: Up to Day 40

  18. Changes from baseline on heart rate

    Measured: Up to Day 40

  19. Changes from baseline on NFS

    Measured: Up to Day 40

  20. Changes from baseline on INR/PTT

    Measured: Up to Day 40

  21. Changes from baseline on platelet count

    Measured: Up to Day 40

  22. Changes from baseline on plasma fibrinogen level

    Measured: Up to Day 40

  23. Changes from baseline on plasma D-Dimers level

    Measured: Up to Day 40

  24. Changes from baseline on serum-glucose level

    Measured: Up to Day 40

  25. Changes from baseline on urea level

    Measured: Up to Day 40

  26. Changes from baseline on creatinemia

    Measured: Up to Day 40

  27. Changes from baseline on LFTs (ASAT/ALAT)

    Measured: Up to Day 40

  28. Changes from baseline on CRP level

    Measured: Up to Day 40

  29. Changes from baseline on LDH level

    Measured: Up to Day 40

  30. Changes from baseline on IL6 level

    Measured: Up to Day 40

  31. Changes from baseline on Tnt

    Measured: Up to Day 40

  32. Changes from baseline on NT proBNP

    Measured: Up to Day 40

  33. Changes from baseline on procalcitonin level

    Measured: Up to Day 40

  34. Changes from baseline on ferritin level

    Measured: Up to Day 40

  35. ECG over the course of the study versus screening

    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.

    Measured: Up to Day 40

Timeline

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

  1. First posted9 Dec 2020
  2. Study start16 Dec 2020
  3. Primary completion6 Aug 2021
  4. Study completion6 Aug 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
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 blind
Who is masked
Participant, Care provider, Investigator
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04659109
Sponsor's protocol ID
ACT-CS-006
Other IDs
2020-002733-15
Acronym
GARDEN
Status last verified
Sep 2021
First submitted
30 Nov 2020
Last updated
13 Sep 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Renaud L, Lebozec K, Voors-Pette C, Dogterom P, Billiald P, Jandrot Perrus M, Pletan Y, Machacek M. Population Pharmacokinetic/Pharmacodynamic Modeling of Glenzocimab (ACT017) a Glycoprotein VI Inhibitor of Collagen-Induced Platelet Aggregation. J Clin Pharmacol. 2020 Sep;60(9):1198-1208. doi: 10.1002/jcph.1616. Epub 2020 Jun 4.

    PubMed 32500636

  • Voors-Pette C, Lebozec K, Dogterom P, Jullien L, Billiald P, Ferlan P, Renaud L, Favre-Bulle O, Avenard G, Machacek M, Pletan Y, Jandrot-Perrus M. Safety and Tolerability, Pharmacokinetics, and Pharmacodynamics of ACT017, an Antiplatelet GPVI (Glycoprotein VI) Fab. Arterioscler Thromb Vasc Biol. 2019 May;39(5):956-964. doi: 10.1161/ATVBAHA.118.312314.

    PubMed 31017822

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing glenzocimab in people with SARS-CoV Infection and Acute Respiratory Distress Syndrome, run by Acticor Biotech at 1 site 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 24 inclusion and 10 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 13 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Progression from moderate to severe respiratory distress assessed at Day 4 (time frame: Day 4). 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 NCT04659109, which also lists 2 linked publications.

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 13 Sep 2021.

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