Trials / Terminated
TerminatedNCT04393038
ABX464 in Treating Inflammation and Preventing Acute Respiratory Failure in Patients With COVID-19
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.
- Status
- Terminated
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 509 (actual)
- Sponsor
- Abivax S.A. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ABX464 | ABX464 50mg QD for 28 days + Standard of Care |
| DRUG | Placebo | Placebo 50mg QD for 28 days + Standard of Care |
Timeline
- Start date
- 2020-07-01
- Primary completion
- 2021-03-05
- Completion
- 2021-04-16
- First posted
- 2020-05-19
- Last updated
- 2025-11-26
- Results posted
- 2025-11-26
Locations
30 sites across 8 countries: Belgium, Brazil, France, Germany, Italy, Mexico, Spain, United Kingdom
Source: ClinicalTrials.gov record NCT04393038. Inclusion in this directory is not an endorsement.