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

NCT04659109 | Completed Phase 2 DMC

• 2 other identifiers: ACT-CS-0062020-002733-15
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Covid 19; ARDS; SARS-Cov; glenzocimab; Acute Respiratory Distress Syndrome; ACT017; glycoprotein VI; antiplatelet agent

Outcome Measures

Primary Outcomes (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

  Day 4

Secondary Outcomes (35)

• All cause mortality at day 40

  Day 40 (maximum)

• WHO-COVID-19 Scale

  Up to Day 40

• NEWS-2 Scale

  Up to Day 40

• Respiratory Rate status (RR)

  Up to Day 40

• Hypoxemia status

  Up to Day 40

Study Arms (2)

glenzocimab 1000 mg

EXPERIMENTAL

Drug: glenzocimab

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

glenzocimab DRUG

IV administration as a sterile product

Also known as: ACT017

glenzocimab 1000 mg

Placebo DRUG

IV administration

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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,

You may not qualify if:

• 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,
• Pregnancy or breastfeeding,
• Prior cardiopulmonary resuscitation \<10 days,
• Allergy or hypersensitivity to drugs of the same class

Sponsors & Collaborators

• Acticor Biotech: lead

Study Sites (1)

Hôpital de Hautepierre

Strasbourg, 67091, France

Location

Related Publications (2)

• 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.

  PMID: 32500636 BACKGROUND

• 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.

  PMID: 31017822 BACKGROUND

MeSH Terms

Conditions

Severe Acute Respiratory Syndrome; Respiratory Distress Syndrome; COVID-19

Interventions

glenzocimab

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Respiration Disorders; Pneumonia, Viral; Pneumonia

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A randomized, double blind, multicenter, placebo-controlled, parallel group, fixed dose, phase II study. The study evaluates the efficacy and safety of glenzocimab.

Study Record Dates

• First Submitted: November 30, 2020
• First Posted: December 9, 2020
• Study Start: December 16, 2020
• Primary Completion: August 6, 2021
• Study Completion: August 6, 2021
• Last Updated: September 13, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)