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

Sponsor
Abivax S.A. (Industry)
Overall Status
Terminated
CT.gov ID
NCT04393038
Collaborator
(none)
509
30
2
9.5
17
1.8

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
Phase 2/Phase 3

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 Design

Study Type:
Interventional
Actual Enrollment :
509 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Phase 2/3, randomized, double blind, placebo-controlled studyPhase 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 :
Jul 1, 2020
Actual Primary Completion Date :
Mar 5, 2021
Actual Study Completion Date :
Apr 16, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: ABX464

ABX464 - Capsules + Standard of Care (SOC)

Drug: ABX464
ABX464 50mg QD for 28 days + Standard of Care

Placebo Comparator: Placebo

Placebo - Capsules + Standard of Care (SOC)

Drug: Placebo
Placebo 50mg QD for 28 days + Standard of Care

Outcome Measures

Primary Outcome Measures

  1. Rate of patients with no invasive or non-invasive mechanical ventilation (IMV and NIV, respectively), but excluding simple nasal/mask oxygen supplementation, and who are alive [at the end of the 28-day treatment period]

Secondary Outcome Measures

  1. Rate of patients hospitalized [28-day treatment period]

  2. Percentage of patients reporting each severity rating on a 7-point ordinal scale [28-day treatment period]

    7-point ordinal scale is defined as Not hospitalized, no limitations on activities; Not hospitalized, limitation on activities; Hospitalized, not requiring supplemental oxygen; Hospitalized, requiring supplemental oxygen; Hospitalized, on non-invasive ventilation or high flow oxygen devices; Hospitalized, on invasive mechanical ventilation or ECMO; Death

  3. Change from enrolment in inflammatory markers in plasma and in immune phenotype and assessment of cell-activation markers in PBMCs [at each study visit during the 28-day treatment period]

  4. Rate of patients requiring oxygen supplementation [28-day treatment period]

  5. Time to hospitalization [28-day treatment period]

  6. Time to assisted ventilation and oxygen supplementation [28-day treatment period]

  7. Change from baseline in microRNA-124 levels [at each study visit during the 28-day treatment period]

  8. Change from baseline in CRP, Troponin I & T and D-dimer [at each study visit during the 28-day treatment period]

  9. SARS-CoV-2 viral load [at each study visit during the 28-day treatment period]

    Nasopharyngeal sample and/or in blood

  10. Number and rates of participants with Treatment Emergent Adverse Event [28-day treatment period]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. Adult (≥ 18 years old) men or women, hospitalized or not hospitalized, diagnosed for SARS-CoV-2 infection by PCR, with at least one associated risk factor. Considered risk factors are:
  • Age ≥ 65 years

  • Obesity defined as BMI ≥ 30

  • Recent history of uncontrolled High Blood Pressure (SBP > 150 mm Hg DBP >100 mm Hg) according to investigator

  • Treated diabetes (type I or II)

  • History of ischemic cardiovascular disease

  1. Symptomatic patients at enrollment. Symptoms are defined as fever (body temperature ≥ 37.8 C oral/tympanic, or ≥ 38.2 C rectal) for more than 24 hours associated either with headache, sore throat, dry cough, fatigue, chest pain or choking sensation (with no associated respiratory distress), myalgia, anosmia or ageusia.

  2. Patients with pulse oximetry arterial saturation ≥ 92 % on room air at enrolment.

  3. Patients with the following hematological and biochemical laboratory parameters obtained within 7 days prior to Day 0:

  • Hemoglobin above 9.0 g / dL

  • Absolute Neutrophil Count ≥ 1000 / mm3

  • Platelets ≥ 100 000 mm3;

  • Creatinine clearance ≥ 50 mL / min by the Cockcroft Gault formula

  • Total serum bilirubin < 2 x ULN

  • Alkaline phosphatase < 2 x ULN, AST (SGOT) and ALT (SGPT) < 3 x ULN;

Exclusion Criteria:
  1. Patients with moderate or severe acute respiratory failure or requiring noninvasive ventilation or oxygen or with SpO2 < 92% or tachypnea (respiratory rate ≥ 30 breaths/min).

  2. Patients treated with immunosuppressors and/or immunomodulators.

  3. Engrafted patients (organ and/or hematopoietic stem cells).

  4. Patients with uncontrolled auto-immune disease.

  5. Patients with known or suspected active (i.e. not controlled) bacterial, viral (excluding COVID-19) or fungal infections.

  6. Patients with preexisting, severe and not controlled organ failure.

  7. History or active malignancy requiring chemotherapy or radiation therapy (excluding 2 years disease free survivor patients).

  8. Pregnant or breast-feeding women.

  9. Illicit drug or alcohol abuse or dependence that may compromise the patient's safety or adherence to the study protocol.

  10. Use of any investigational or non-registered product within 3 months or within 5 half-lives preceding baseline, whichever is longer.

  11. Hypersensitivity to ABX464 and/or its excipients.

  12. Any condition, which in the opinion of the investigator, could compromise the patient's safety or adherence to the study protocol.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Centre hospitalier Saint Pierre Brussels Belgium 1000
2 Hôpital Erasme Brussels Belgium 1070
3 UZ Gent Gent Belgium 9000
4 Fundacao de Medicina Tropical Doutor Heitor Vieira Dourado - Instituto de Pesquisa Clínica Carlos Borborema Manaus Amazonas Brazil 69040-000
5 Centro Oncológico de Roraima - CECOR - NAP Boa Vista Roraima Brazil 69310-000
6 Hospital das Clinicas da FMUSP São Paulo Sao Paulo Brazil 05403-000
7 Instituto Nacional de Infectologia Evandro Chagas - FIOCRUZ Rio de Janeiro Rio De Janeiro Brazil 21040-360
8 Conjunto Hospitalar do Mandaqui Sao Paulo Brazil 02401-400
9 Hôpital Nord Amiens France 80000
10 Centre Hospitalier Départemental de Vendée La Roche-sur-Yon France 85000
11 Centre Hospitalier Universitaire de Nice Nice France 06003
12 Hôpital Saint-Antoine Paris France 75571
13 Universitätsmedizin Mannheim Ruprecht-Karls-Universität Heid Mannheim Baden-Württemberg Germany 68167
14 Universitätsklinikum Bonn Bonn Nordrhein-Westfalen Germany 53127
15 Asklepios Klinik St. Georg Hamburg Germany 20099
16 Asklepios Klinik Altona Hamburg Germany 22763
17 Fondazione IRCCS Cà Granda - Ospedale Maggiore Policlinico - Infectious Diseases Milano Lombardia Italy 20122
18 Ospedale San Paolo Milano Lombardia Italy 20142
19 Ospedale Luigi Sacco, AO-PU Milano Lombardia Italy 20157
20 Ospedale di Vittorio Veneto - Medecina generale Vittorio Veneto Treviso Italy 31029
21 Ospedale A. Manzonidi Lecco - ASST Lecco Lecco Italy 23900
22 Ospedale Niguarda Milano Italy 20162
23 Consultorio médico Mérida Yucatan Mexico 97070
24 Centro de Prevención y Rehabilitación de Enfermedades Pulmon Nuevo León Mexico 64460
25 Hospital Universitari Germans Trias i Pujol Badalona Barcelona Spain 08916
26 H.G.U. Alicante Alicante Spain 03010
27 Hospital del Mar Barcelona Spain 08003
28 Hospital de La Princesa Madrid Spain 28006
29 Hospital Universitario Infanta Leonor Madrid Spain 28031
30 Royal Free Hospital London United Kingdom NW3 2QG

Sponsors and Collaborators

  • Abivax S.A.

Investigators

  • Principal Investigator: Eric CUA, MD, Centre Hospitalier Universitaire de Nice

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Abivax S.A.
ClinicalTrials.gov Identifier:
NCT04393038
Other Study ID Numbers:
  • ABX464-401
First Posted:
May 19, 2020
Last Update Posted:
Jun 30, 2021
Last Verified:
Jun 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Abivax S.A.
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 30, 2021