ABX464 in Treating Inflammation and Preventing Acute Respiratory Failure in Patients With COVID-19 (Mir-Age)

ABX464 in Treating Inflammation and Preventing Acute Respiratory Failure in Patients With COVID-19 (Mir-Age)

Brief 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).

Detailed Description:
This phase 2/3 study will evaluate the efficacy and safety of ABX464 50mg QD (oral capsule), on treating inflammation and preventing acute respiratory failure in patients infected with SARS-CoV-2.

Eligible patients will be randomized according to a 2:1 ratio into 2 treatment cohorts as follows:
- Standard of Care + Placebo cohort: 344 patients
- Standard of Care + ABX464 50mg QD: 690 patients

Study design:
The study will consist of 2 periods:
- Treatment phase: randomized patients will be treated for 28 days
- Safety follow-up phase of 14 days after which the End of Study visit (EOS) will be performed.


Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 1034 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Phase 2/3, randomized, double blind, placebo-controlled study
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Blinded treatment bottles
Primary Purpose: Treatment
Official Title: A Phase 2/3, Randomized, Double Blind, Placebo-controlled Study to Evaluate the Efficacy and the Safety of ABX464 in Treating Inflammation and Preventing COVID-19 Associated 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.
Actual Study Start Date: May 1, 2020
Estimated Primary Completion Date: December 30, 2020
Estimated Study Completion Date: April 30, 2021

Arm:
- Experimental: ABX464
- Placebo Comparator: Placebo

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