Back to resultsABX464 in Treating Inflammation and Preventing Acute Respiratory Failure in Patients With COVID-19 (Mir-Age)
Primary Purpose
COVID-19
Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
ABX464
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19 focused on measuring COVID-19, ABX464
Eligibility Criteria
Inclusion Criteria:
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
- 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.
- Patients with pulse oximetry arterial saturation ≥ 92 % on room air at enrolment.
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:
- 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).
- Patients treated with immunosuppressors and/or immunomodulators.
- Engrafted patients (organ and/or hematopoietic stem cells).
- Patients with uncontrolled auto-immune disease.
- Patients with known or suspected active (i.e. not controlled) bacterial, viral (excluding COVID-19) or fungal infections.
- Patients with preexisting, severe and not controlled organ failure.
- History or active malignancy requiring chemotherapy or radiation therapy (excluding 2 years disease free survivor patients).
- Pregnant or breast-feeding women.
- Illicit drug or alcohol abuse or dependence that may compromise the patient's safety or adherence to the study protocol.
- Use of any investigational or non-registered product within 3 months or within 5 half-lives preceding baseline, whichever is longer.
- Hypersensitivity to ABX464 and/or its excipients.
- Any condition, which in the opinion of the investigator, could compromise the patient's safety or adherence to the study protocol.
Sites / Locations
- Centre hospitalier Saint Pierre
- Hôpital Erasme
- UZ Gent
- Fundacao de Medicina Tropical Doutor Heitor Vieira Dourado - Instituto de Pesquisa Clínica Carlos Borborema
- Centro Oncológico de Roraima - CECOR - NAP
- Hospital das Clinicas da FMUSP
- Instituto Nacional de Infectologia Evandro Chagas - FIOCRUZ Rio de Janeiro
- Conjunto Hospitalar do Mandaqui
- Hôpital Nord
- Centre Hospitalier Départemental de Vendée
- Centre Hospitalier Universitaire de Nice
- Hôpital Saint-Antoine
- Universitätsmedizin Mannheim Ruprecht-Karls-Universität Heid
- Universitätsklinikum Bonn
- Asklepios Klinik St. Georg
- Asklepios Klinik Altona
- Fondazione IRCCS Cà Granda - Ospedale Maggiore Policlinico - Infectious Diseases
- Ospedale San Paolo
- Ospedale Luigi Sacco, AO-PU
- Ospedale di Vittorio Veneto - Medecina generale
- Ospedale A. Manzonidi Lecco - ASST Lecco
- Ospedale Niguarda
- Consultorio médico
- Centro de Prevención y Rehabilitación de Enfermedades Pulmon
- Hospital Universitari Germans Trias i Pujol
- H.G.U. Alicante
- Hospital del Mar
- Hospital de La Princesa
- Hospital Universitario Infanta Leonor
- Royal Free Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
ABX464
Placebo
Arm Description
ABX464 - Capsules + Standard of Care (SOC)
Placebo - Capsules + Standard of Care (SOC)
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Rate of patients hospitalized
Percentage of patients reporting each severity rating on a 7-point ordinal scale
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
Change from enrolment in inflammatory markers in plasma and in immune phenotype and assessment of cell-activation markers in PBMCs
Rate of patients requiring oxygen supplementation
Time to hospitalization
Time to assisted ventilation and oxygen supplementation
Change from baseline in microRNA-124 levels
Change from baseline in CRP, Troponin I & T and D-dimer
SARS-CoV-2 viral load
Nasopharyngeal sample and/or in blood
Number and rates of participants with Treatment Emergent Adverse Event
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04393038
Brief Title
ABX464 in Treating Inflammation and Preventing Acute Respiratory Failure in Patients With COVID-19
Acronym
Mir-Age
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.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Terminated
Why Stopped
Interim analysis concludes that the study is futile
Study Start Date
July 1, 2020 (Actual)
Primary Completion Date
March 5, 2021 (Actual)
Study Completion Date
April 16, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abivax S.A.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
COVID-19, ABX464
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Phase 2/3, randomized, double blind, placebo-controlled study
Masking
ParticipantCare ProviderInvestigator
Masking Description
Blinded treatment bottles
Allocation
Randomized
Enrollment
509 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ABX464
Arm Type
Experimental
Arm Description
ABX464 - Capsules + Standard of Care (SOC)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo - Capsules + Standard of Care (SOC)
Intervention Type
Drug
Intervention Name(s)
ABX464
Intervention Description
ABX464 50mg QD for 28 days + Standard of Care
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo 50mg QD for 28 days + Standard of Care
Primary Outcome Measure Information:
Title
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
Time Frame
at the end of the 28-day treatment period
Secondary Outcome Measure Information:
Title
Rate of patients hospitalized
Time Frame
28-day treatment period
Title
Percentage of patients reporting each severity rating on a 7-point ordinal scale
Description
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
Time Frame
28-day treatment period
Title
Change from enrolment in inflammatory markers in plasma and in immune phenotype and assessment of cell-activation markers in PBMCs
Time Frame
at each study visit during the 28-day treatment period
Title
Rate of patients requiring oxygen supplementation
Time Frame
28-day treatment period
Title
Time to hospitalization
Time Frame
28-day treatment period
Title
Time to assisted ventilation and oxygen supplementation
Time Frame
28-day treatment period
Title
Change from baseline in microRNA-124 levels
Time Frame
at each study visit during the 28-day treatment period
Title
Change from baseline in CRP, Troponin I & T and D-dimer
Time Frame
at each study visit during the 28-day treatment period
Title
SARS-CoV-2 viral load
Description
Nasopharyngeal sample and/or in blood
Time Frame
at each study visit during the 28-day treatment period
Title
Number and rates of participants with Treatment Emergent Adverse Event
Time Frame
28-day treatment period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
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.
Patients with pulse oximetry arterial saturation ≥ 92 % on room air at enrolment.
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:
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).
Patients treated with immunosuppressors and/or immunomodulators.
Engrafted patients (organ and/or hematopoietic stem cells).
Patients with uncontrolled auto-immune disease.
Patients with known or suspected active (i.e. not controlled) bacterial, viral (excluding COVID-19) or fungal infections.
Patients with preexisting, severe and not controlled organ failure.
History or active malignancy requiring chemotherapy or radiation therapy (excluding 2 years disease free survivor patients).
Pregnant or breast-feeding women.
Illicit drug or alcohol abuse or dependence that may compromise the patient's safety or adherence to the study protocol.
Use of any investigational or non-registered product within 3 months or within 5 half-lives preceding baseline, whichever is longer.
Hypersensitivity to ABX464 and/or its excipients.
Any condition, which in the opinion of the investigator, could compromise the patient's safety or adherence to the study protocol.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric CUA, MD
Organizational Affiliation
Centre Hospitalier Universitaire de Nice
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre hospitalier Saint Pierre
City
Brussels
ZIP/Postal Code
1000
Country
Belgium
Facility Name
Hôpital Erasme
City
Brussels
ZIP/Postal Code
1070
Country
Belgium
Facility Name
UZ Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Fundacao de Medicina Tropical Doutor Heitor Vieira Dourado - Instituto de Pesquisa Clínica Carlos Borborema
City
Manaus
State/Province
Amazonas
ZIP/Postal Code
69040-000
Country
Brazil
Facility Name
Centro Oncológico de Roraima - CECOR - NAP
City
Boa Vista
State/Province
Roraima
ZIP/Postal Code
69310-000
Country
Brazil
Facility Name
Hospital das Clinicas da FMUSP
City
São Paulo
State/Province
Sao Paulo
ZIP/Postal Code
05403-000
Country
Brazil
Facility Name
Instituto Nacional de Infectologia Evandro Chagas - FIOCRUZ Rio de Janeiro
City
Rio De Janeiro
ZIP/Postal Code
21040-360
Country
Brazil
Facility Name
Conjunto Hospitalar do Mandaqui
City
Sao Paulo
ZIP/Postal Code
02401-400
Country
Brazil
Facility Name
Hôpital Nord
City
Amiens
ZIP/Postal Code
80000
Country
France
Facility Name
Centre Hospitalier Départemental de Vendée
City
La Roche-sur-Yon
ZIP/Postal Code
85000
Country
France
Facility Name
Centre Hospitalier Universitaire de Nice
City
Nice
ZIP/Postal Code
06003
Country
France
Facility Name
Hôpital Saint-Antoine
City
Paris
ZIP/Postal Code
75571
Country
France
Facility Name
Universitätsmedizin Mannheim Ruprecht-Karls-Universität Heid
City
Mannheim
State/Province
Baden-Württemberg
ZIP/Postal Code
68167
Country
Germany
Facility Name
Universitätsklinikum Bonn
City
Bonn
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
53127
Country
Germany
Facility Name
Asklepios Klinik St. Georg
City
Hamburg
ZIP/Postal Code
20099
Country
Germany
Facility Name
Asklepios Klinik Altona
City
Hamburg
ZIP/Postal Code
22763
Country
Germany
Facility Name
Fondazione IRCCS Cà Granda - Ospedale Maggiore Policlinico - Infectious Diseases
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20122
Country
Italy
Facility Name
Ospedale San Paolo
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20142
Country
Italy
Facility Name
Ospedale Luigi Sacco, AO-PU
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20157
Country
Italy
Facility Name
Ospedale di Vittorio Veneto - Medecina generale
City
Vittorio Veneto
State/Province
Treviso
ZIP/Postal Code
31029
Country
Italy
Facility Name
Ospedale A. Manzonidi Lecco - ASST Lecco
City
Lecco
ZIP/Postal Code
23900
Country
Italy
Facility Name
Ospedale Niguarda
City
Milano
ZIP/Postal Code
20162
Country
Italy
Facility Name
Consultorio médico
City
Mérida
State/Province
Yucatan
ZIP/Postal Code
97070
Country
Mexico
Facility Name
Centro de Prevención y Rehabilitación de Enfermedades Pulmon
City
Nuevo León
ZIP/Postal Code
64460
Country
Mexico
Facility Name
Hospital Universitari Germans Trias i Pujol
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
H.G.U. Alicante
City
Alicante
ZIP/Postal Code
03010
Country
Spain
Facility Name
Hospital del Mar
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Hospital de La Princesa
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
Hospital Universitario Infanta Leonor
City
Madrid
ZIP/Postal Code
28031
Country
Spain
Facility Name
Royal Free Hospital
City
London
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
ABX464 in Treating Inflammation and Preventing Acute Respiratory Failure in Patients With COVID-19
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