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Targeting GPVI with glenzocimab in COVID-19 patients: Results from a randomized clinical trial

Pottecher et al., PLOS ONE, doi:10.1371/journal.pone.0302897, NCT04659109
Jun 2024  
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Worsening according to.. -60% Improvement Relative Risk Progression from modera.. -54% PaO2/FiO2 ≤ 100 -49% Respiratory rate ≥ 30/min -413% Glenzocimab  Pottecher et al.  EARLY TREATMENT  DB RCT Is early treatment with glenzocimab beneficial for COVID-19? Double-blind RCT 62 patients in multiple countries (Dec 2020 - Aug 2021) Higher progression (p=0.28) and worse recovery (p=0.53), not sig. c19early.org Pottecher et al., PLOS ONE, June 2024 Favorsglenzocimab Favorscontrol 0 0.5 1 1.5 2+
RCT 61 hospitalized COVID-19 patients showing no significant difference in primary outcomes with glenzocimab (an anti-GPVI antibody) vs. placebo. Authors report glenzocimab showed a significant improvement in the NEWS-2 category at day 4, however the actual results are not provided. There were no deaths and no significant safety signals in either group. The results suggest targeting GPVI at this stage of disease severity may not be sufficient to prevent progression to ARDS.
worsening according to ventilation system, O2, and SpO2, 60.0% higher, RR 1.60, p = 0.28, treatment 12 of 30 (40.0%), control 8 of 32 (25.0%).
progression from moderate to severe, 54.1% higher, RR 1.54, p = 0.29, treatment 13 of 30 (43.3%), control 9 of 32 (28.1%).
PaO2/FiO2 ≤ 100, 49.3% higher, RR 1.49, p = 0.53, treatment 7 of 30 (23.3%), control 5 of 32 (15.6%).
respiratory rate ≥ 30/min, 413.3% higher, RR 5.13, p = 0.23, treatment 2 of 30 (6.7%), control 0 of 32 (0.0%), continuity correction due to zero event (with reciprocal of the contrasting arm).
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Pottecher et al., 17 Jun 2024, Double Blind Randomized Controlled Trial, placebo-controlled, multiple countries, peer-reviewed, 15 authors, study period December 2020 - August 2021, trial NCT04659109 (history). Contact: elie.toledano@acticor-biotech.com, garden.study@acticor-biotech.com.
This PaperGlenzocimabAll
Targeting GPVI with glenzocimab in COVID-19 patients: Results from a randomized clinical trial
Julien Pottecher, Francois Raffi, Martine Jandrot-Perrus, Sophie Binay, Andrea Comenducci, Violaine Desort-Henin, Déborah François, Shahin Gharakhanian, Marilyn Labart, Adeline Meilhoc, Elie Toledano, Yannick Pletan, Gilles Avenard, Victor H Sato
PLOS ONE, doi:10.1371/journal.pone.0302897
Background Glenzocimab is a novel antithrombotic agent which targets platelet glycoprotein VI (GPVI) and does not induce haemorrhage. SARS-CoV-2 triggers a prothrombotic state and lung injury whose mechanisms include coagulopathy, endothelial dysfunction, and inflammation with dysregulated platelets. Methods and patients GARDEN was a randomised double-blind, exploratory phase II study of glenzocimab in SARS-CoV-2 respiratory failure (NCT04659109). PCR+ adults in Brazil and France (7 centres) were randomized to standard-of-care (SOC) plus glenzocimab (1000 mg/dayx3 days) or placebo, followed for 40 days. Primary efficacy endpoint was clinical progression at Day 4. All analyses concerned the intention-to-treat population. Results Between December 2020 and August 2021, 61 patients received at least one dose (30 glenzocimab vs 32 placebo) and 58 completed the study (29 vs 29). Clinical progression of COVID-19 ARDS was not statistically different between glenzocimab and placebo arms (43.3% and 29.0%, respectively; p = 0.245). Decrease in the NEWS-2 category at D4 was statistically significant (p = 0.0290) in the glenzocimab arm vs placebo. No Serious Adverse Event (SAE) was deemed related to study drug; bleeding related events were reported in 6 patients (7 events) and 4 patients (4 events) in glenzocimab and placebo arms, respectively.
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SARS-CoV-2 triggers a prothrombotic state and lung ' 'injury whose mechanisms include coagulopathy, endothelial dysfunction, and inflammation with ' 'dysregulated platelets.</jats:p>\n' '</jats:sec>\n' '<jats:sec id="sec002">\n' '<jats:title>Methods and patients</jats:title>\n' '<jats:p>GARDEN was a randomised double-blind, exploratory phase II study of glenzocimab in ' 'SARS-CoV-2 respiratory failure (NCT04659109). PCR+ adults in Brazil and France (7 centres) ' 'were randomized to standard-of-care (SOC) plus glenzocimab (1000 mg/dayx3 days) or placebo, ' 'followed for 40 days. Primary efficacy endpoint was clinical progression at Day 4. All ' 'analyses concerned the intention-to-treat population.</jats:p>\n' '</jats:sec>\n' '<jats:sec id="sec003">\n' '<jats:title>Results</jats:title>\n' '<jats:p>Between December 2020 and August 2021, 61 patients received at least one dose (30 ' 'glenzocimab vs 32 placebo) and 58 completed the study (29 <jats:italic>vs</jats:italic> 29). ' 'Clinical progression of COVID-19 ARDS was not statistically different between glenzocimab and ' 'placebo arms (43.3% and 29.0%, respectively; <jats:italic>p = ' '0</jats:italic>.<jats:italic>245</jats:italic>). Decrease in the NEWS-2 category at D4 was ' 'statistically significant (<jats:italic>p = 0</jats:italic>.<jats:italic>0290</jats:italic>) ' 'in the glenzocimab arm vs placebo. No Serious Adverse Event (SAE) was deemed related to study ' 'drug; bleeding related events were reported in 6 patients (7 events) and 4 patients (4 ' 'events) in glenzocimab and placebo arms, respectively.</jats:p>\n' '</jats:sec>\n' '<jats:sec id="sec004">\n' '<jats:title>Conclusions</jats:title>\n' '<jats:p>Therapeutic GPVI inhibition assessment during COVID-19 was conducted in response to a ' 'Public Health emergency. Glenzocimab in coagulopathic patients under therapeutic heparin was ' 'neither associated with increased bleeding, nor SAE. Clinical impact of glenzocimab on ' 'COVID-19 ARDS was not demonstrated. A potential role for GPVI inhibition in other types of ' 'ARDS deserves further experimentation. Glenzocimab is currently studied in stroke (ACTISAVE: ' 'NCT05070260) and cardiovascular indications.</jats:p>\n' '</jats:sec>', 'DOI': '10.1371/journal.pone.0302897', 'type': 'journal-article', 'created': {'date-parts': [[2024, 6, 17]], 'date-time': '2024-06-17T17:59:51Z', 'timestamp': 1718647191000}, 'page': 'e0302897', 'update-policy': 'http://dx.doi.org/10.1371/journal.pone.corrections_policy', 'source': 'Crossref', 'is-referenced-by-count': 0, 'title': 'Targeting GPVI with glenzocimab in COVID-19 patients: Results from a randomized clinical trial', 'prefix': '10.1371', 'volume': '19', 'author': [ { 'ORCID': 'http://orcid.org/0000-0001-6073-4354', 'authenticated-orcid': True, 'given': 'Julien', 'family': 'Pottecher', 'sequence': 'first', 'affiliation': []}, {'given': 'Francois', 'family': 'Raffi', 'sequence': 'additional', 'affiliation': []}, {'given': 'Martine', 'family': 'Jandrot-Perrus', 'sequence': 'additional', 'affiliation': []}, {'given': 'Sophie', 'family': 'Binay', 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With COVID-19: A Randomized Clinical Trial', 'volume': '327', 'author': 'REMAP-CAP Writing Committee for the REMAP-CAP Investigators', 'year': '2022', 'journal-title': 'JAMA'}, { 'key': 'pone.0302897.ref027', 'doi-asserted-by': 'crossref', 'first-page': '3884', 'DOI': '10.1182/bloodadvances.2022007143', 'article-title': 'Platelet activation and partial desensitization are associated with ' 'viral xenophagy in patients with severe COVID-19', 'volume': '6', 'author': 'C Garcia', 'year': '2022', 'journal-title': 'Blood Adv'}, { 'key': 'pone.0302897.ref028', 'doi-asserted-by': 'crossref', 'first-page': '1176', 'DOI': '10.1161/CIRCULATIONAHA.120.048488', 'article-title': 'Immunothrombotic Dysregulation in COVID-19 Pneumonia Is Associated With ' 'Respiratory Failure and Coagulopathy', 'volume': '142', 'author': 'L Nicolai', 'year': '2020', 'journal-title': 'Circulation'}, { 'key': 'pone.0302897.ref029', 'doi-asserted-by': 'crossref', 'first-page': '100434', 'DOI': '10.1016/j.eclinm.2020.100434', 'article-title': 'Megakaryocytes and platelet-fibrin thrombi characterize multi-organ ' 'thrombosis at autopsy in COVID-19: A case series', 'volume': '24', 'author': 'AV Rapkiewicz', 'year': '2020', 'journal-title': 'EClinicalMedicine'}, { 'key': 'pone.0302897.ref030', 'doi-asserted-by': 'crossref', 'first-page': '420', 'DOI': '10.1016/S2213-2600(20)30076-X', 'article-title': 'Pathological findings of COVID-19 associated with acute respiratory ' 'distress syndrome', 'volume': '8', 'author': 'Z Xu', 'year': '2020', 'journal-title': 'Lancet Respir Med'}, { 'key': 'pone.0302897.ref031', 'doi-asserted-by': 'crossref', 'first-page': '1258', 'DOI': '10.1055/a-1347-5555', 'article-title': 'Platelets are Hyperactivated but Show Reduced Glycoprotein VI ' 'Reactivity in COVID-19', 'volume': '121', 'author': 'V Léopold', 'year': '2021', 'journal-title': 'Patients. Thromb Haemost'}, { 'key': 'pone.0302897.ref032', 'doi-asserted-by': 'crossref', 'first-page': '1198', 'DOI': '10.1002/jcph.1616', 'article-title': 'Population Pharmacokinetic/Pharmacodynamic Modeling of Glenzocimab ' '(ACT017) a Glycoprotein VI Inhibitor of Collagen-Induced Platelet ' 'Aggregation', 'volume': '60', 'author': 'L Renaud', 'year': '2020', 'journal-title': 'J Clin Pharmacol'}, { 'key': 'pone.0302897.ref033', 'doi-asserted-by': 'crossref', 'first-page': '143', 'DOI': '10.1016/S0140-6736(21)01825-0', 'article-title': 'Aspirin in patients admitted to hospital with COVID-19 (RECOVERY): a ' 'randomised, controlled, open-label, platform trial', 'volume': '399', 'author': 'RECOVERY Collaborative Group', 'year': '2022', 'journal-title': 'Lancet'}, { 'key': 'pone.0302897.ref034', 'doi-asserted-by': 'crossref', 'first-page': '227', 'DOI': '10.1001/jama.2021.23605', 'article-title': 'Effect of P2Y12 Inhibitors on Survival Free of Organ Support Among ' 'Non-Critically Ill Hospitalized Patients With COVID-19: A Randomized ' 'Clinical Trial', 'volume': '327', 'author': 'JS Berger', 'year': '2022', 'journal-title': 'JAMA'}, { 'key': 'pone.0302897.ref035', 'doi-asserted-by': 'crossref', 'first-page': '639', 'DOI': '10.1038/s41577-022-00762-9', 'article-title': 'Understanding COVID-19-associated coagulopathy', 'volume': '22', 'author': 'EM Conway', 'year': '2022', 'journal-title': 'Nat Rev Immunol'}, { 'key': 'pone.0302897.ref036', 'doi-asserted-by': 'crossref', 'first-page': '2814', 'DOI': '10.1111/jth.15517', 'article-title': 'Association of prehospital antiplatelet therapy with survival in ' 'patients hospitalized with COVID-19: A propensity score-matched ' 'analysis', 'volume': '19', 'author': 'JH Chow', 'year': '2021', 'journal-title': 'J Thromb Haemost'}, { 'key': 'pone.0302897.ref037', 'doi-asserted-by': 'crossref', 'first-page': '130', 'DOI': '10.1136/heartjnl-2021-319552', 'article-title': 'Antiplatelet therapy and outcome in COVID-19: the Health Outcome ' 'Predictive Evaluation Registry', 'volume': '108', 'author': 'F Santoro', 'year': '2022', 'journal-title': 'Heart'}], 'container-title': 'PLOS ONE', 'original-title': [], 'language': 'en', 'link': [ { 'URL': 'https://dx.plos.org/10.1371/journal.pone.0302897', 'content-type': 'unspecified', 'content-version': 'vor', 'intended-application': 'similarity-checking'}], 'deposited': { 'date-parts': [[2024, 6, 17]], 'date-time': '2024-06-17T18:00:20Z', 'timestamp': 1718647220000}, 'score': 1, 'resource': {'primary': {'URL': 'https://dx.plos.org/10.1371/journal.pone.0302897'}}, 'subtitle': [], 'editor': [{'given': 'Esteban', 'family': 'Nannini', 'sequence': 'first', 'affiliation': []}], 'short-title': [], 'issued': {'date-parts': [[2024, 6, 17]]}, 'references-count': 37, 'journal-issue': {'issue': '6', 'published-online': {'date-parts': [[2024, 6, 17]]}}, 'URL': 'http://dx.doi.org/10.1371/journal.pone.0302897', 'relation': {}, 'ISSN': ['1932-6203'], 'subject': [], 'container-title-short': 'PLoS ONE', 'published': {'date-parts': [[2024, 6, 17]]}}
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Please send us corrections, updates, or comments. c19early involves the extraction of 100,000+ datapoints from thousands of papers. Community updates help ensure high accuracy. Treatments and other interventions are complementary. All practical, effective, and safe means should be used based on risk/benefit analysis. No treatment or intervention is 100% available and effective for all current and future variants. We do not provide medical advice. Before taking any medication, consult a qualified physician who can provide personalized advice and details of risks and benefits based on your medical history and situation. FLCCC and WCH provide treatment protocols.
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