MiR-AGE
Research type
Research Study
Full 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. (the MiR-AGE study).
IRAS ID
284756
Contact name
Marwa Ali
Contact email
Sponsor organisation
ABIVAX
Eudract number
2020-001673-75
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 5 months, 31 days
Research summary
Summary of Research
This phase 2/3 study will evaluate the efficacy and safety of ABX464 50mg (oral capsule), on treating inflammation and preventing acute respiratory failure in patients infected with SARS-CoV-2.Eligible participants will be randomised (selected at random) according to a 2:1 ratio into 2 treatment groups as follows:
- Standard of Care + Placebo cohort: 344 participants
- Standard of Care + ABX464 50mg: 690 participantsThe study will consist of 2 periods:
- Treatment phase: randomised participants will be treated for 28 days
- Safety follow-up phase of 21 days after which the End of Study visit (EOS) will be performed.From Day 0 onwards, randomised participants will be followed by the investigational site at 7 days, 14 days, 21 days and finally 28 days after randomisation.
Should a participant be hospitalised at D0, Day 7 visit will be an on-site visit.
Should a participant not be hospitalised, considering a quarantine period might be applied for infected participants, a remote medical monitoring will be performed by the investigator or site staff every 2 days from D0 and until D14. Every attempt to perform Day 7 on-site visit should be made anyway. For outpatients, an oximeter will be provided at Day 0. During the remote medical monitoring, the participant will be asked to self-measure every day the oxygen saturation, body temperature and will be asked for any potential signs of COVID-19 infection worsening. Following, D14, D21 and D28 will be on-site visits.
If no quarantine period is applied or if participant travel to study site is acceptable as per local regulation, outpatients will perform a D7 visit on-site, and same examinations as hospitalised participants will be done.
At enrolment, all participants should be diagnosed for SARS-CoV-2 infection by PCR.
Approximately 1034 participants will participate in this study through Europe and Brazil.
Summary of Results
Efficacy Results: After 305 randomized patients completed the Day 28 assessment or reached the end of Study and study met the predefined stopping criterion for futility. This result was presented in data and safety monitoring board (DSMB meeting), who recommended study early termination for futility, which led to stopping recruitment, although there was no safety signal detected by data and safety monitoring board (DSMB), no further reviews were conducted due to this.Safety Results: In the overall safety population of 505 patients, 549 treatment emergent adverse events (TEAEs) were reported in 206 patients (61.5 %) in ABX464 group, and 208 treatment emergent adverse events were reported in 83 patients (48.8%) in placebo group.
Period 1: AE set on or worsens before or on Day 28 • A total of 289 patients had at least one treatment emergent adverse events (TEAEs). Of these 206 patients were from ABX464 arm and 83 patients were from placebo arm. Treatment emergent adverse events were more in ABX464 arm than placebo arm.
• 45 patients had 52 Grade ≥3 events. The occurrence of Grade ≥ 3 events was almost similar between both the arms.
• 48 patients experienced at least one treatment emergent serious adverse event (TESAE). Of these 48 patients, 34 patients were from ABX464 group and 14 patients were from placebo group.Period 2: AE set on or worsens after Day 28:
• A total of 73 treatment emergent adverse events were reported in 42 patients. Of these, 38 events in 22 patients were from ABX464 arm and 35 events in 20 patients from placebo arm. 8 patients had 11 Grade ≥3events. The occurrence of Grade ≥ 3 events was higher in placebo arm.
• A total of 8 patients experienced at least one TESAE. Of these 8 patients, 2 patients were from ABX464 arm and 6 were from placebo arm.
• Incidence of treatment emergent serious adverse events (TESAEs) were higher in ABX464 arm than in placebo arm in Period 1. Whereas incidence of treatment emergent serious adverse events (TESAEs) were higher in placebo arm than in ABX464 arm in Period 2.A total of 319 patients had at least one TEAE reported. Of these 319 patients, 141 patients had Grade 1 TEAEs, 123 patients had Grade 2 TEAEs, 42 patients had Grade 3 TEAEs, 5 patients had Grade 4 TEAEs, and 8 patients had Grade 5 TEAEs. Number of patients with Grade 3, Grade 4 and Grade 5 TEAEs were similar in both the arms. Number of patients with Grade 1 and Grade 2 TEAEs were higher in ABX464 arm than in placebo arm. A total of 319 patients had at least one TEAE reported. TEAEs occurred in 276 patients were considered as not related, and TEAEs occurred in 124 patients were considered as related to study treatment. Number of patients with TEAEs considered related to study treatment was higher in ABX464 arm compared to placebo arm. Similarly, number of patients with TEAEs considered not related to study treatment was slightly higher in ABX464 arm compared to placebo arm. No new safety signals were identified and incidence of TEAEs, TESAEs, and deaths were similar in both ABX464 arm and placebo arm.
Conclusions: There was no imbalance between the treatment groups in terms of overall incidence of TEAE, Serious adverse events, deaths, and treatment discontinuations. No new safety signal was identified compared with previous ABX464 studies. ABX464 showed a good safety profile in this "at risk" patient population.
REC name
North West - Haydock Research Ethics Committee
REC reference
20/NW/0284
Date of REC Opinion
2 Jul 2020
REC opinion
Further Information Favourable Opinion