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

NCT ID: NCT04659109

Last Updated: 2021-09-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-16
• Study Completion Date: 2021-08-06

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.

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.

Conditions

SARS-CoV Infection; Acute Respiratory Distress Syndrome; COVID-19; ARDS

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

glenzocimab 1000 mg

Group Type: EXPERIMENTAL

glenzocimab

Intervention Type: DRUG

IV administration as a sterile product

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

IV administration

Interventions

glenzocimab

IV administration as a sterile product

Intervention Type: DRUG

Placebo

IV administration

Intervention Type: DRUG

Other Intervention Names

ACT017

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Acticor Biotech

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hôpital de Hautepierre

Strasbourg, , France

Countries

France

References

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.

Reference Type: BACKGROUND

PMID: 32500636 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31017822 (View on PubMed)

Other Identifiers

2020-002733-15

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

ACT-CS-006

Identifier Type: -

Identifier Source: org_study_id