Abstract
Background: Platelets (plt) may contribute to the inflammatory thrombosis in Cov-ARDS. Glenzocimab a humanized monoclonal antibody fragment against plt glycoprotein VI, inhibiting plt binding to the thrombus does affect physiological hemostasis, is assessed in Stroke (ph.II/II) and thrombotic diseases.
Method: GARDEN (NCT04659109) was a randomized, double -blind, multicenter, parallel group, ph.IIb trial. Patients (pts) randomized 1/1 to Glenzocimab (1000 mg/day/3days)-placebo. All had confirmed SARS-CoV2, moderate respiratory clinical signs and a prothrombotic status. Primary endpoint: day 4 severe progression.
Results: 60 pts enrolled in Brazil & France, aged median 56yrs; 75% male Caucasians with ≥ 1 comorbidity. All had thromboprophylaxis and steroids. Safety analysis confirmed good tolerance of Glenzocimab. No deaths, serious drug-related adverse event nor major bleeding. 31 SAEs in 15 pts mainly related to Cov-ARDS or infection. No difference for the primary endpoint. Insufficient power, imbalance of risk factors (within Glenzocimab group), or lesser role of GPVI in Cov-ARDS pathophysiology are possible reasons.
Conclusion: The GARDEN study was set up to tackle a global Public Health emergency. Glenzocimab was safe in doses three times higher than used in stroke. Albeit efficacy was not shown, overall, GARDEN provides insights into Cov-ARDS.
Footnotes
Cite this article as Eur Respir J 2022; 60: Suppl. 66, 2878.
This article was presented at the 2022 ERS International Congress, in session “-”.
This is an ERS International Congress abstract. No full-text version is available. Further material to accompany this abstract may be available at www.ers-education.org (ERS member access only).
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