drugset / Trial / NCT04393038

ABX464 in Treating Inflammation and Preventing Acute Respiratory Failure in Patients With COVID-19

NCT04393038 ↗

Phase 2/3 Terminated 509 enrolled Abivax S.A.
RandomizedParallel-groupTriple-blindTreatment

Summary

A phase 2/3, randomized, double blind, placebo-controlled study to evaluate the efficacy and the safety of ABX464 in treating inflammation and preventing acute respiratory failure in patients aged ≥65 and patients aged ≥18 with at least one additional risk factor who are infected with SARS-CoV-2 (the MiR-AGE study).

Timeline

Start
2020-07-01
Primary completion
2021-03-05
Completion
2021-04-16

Outcome

Missed primary endpoint

Stopped: “Interim analysis concludes that the study is futile”

release “halting the miR-AGE phase 2b/3 clinical trial in high-risk Covid-19 patients after the independent Data Safety and Monitoring Board (DSMB) recommendation for lack of efficacy.” abivax.com ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Obefazimod Small molecule 50 mg Oral

Indications