Mir-Age: ABX464 in Treating Inflammation and Preventing Acute Respiratory Failure in Patients With COVID-19
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:
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Standard of Care + Placebo cohort: 344 patients
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Standard of Care + ABX464 50mg QD: 690 patients
Study design:
The study will consist of 2 periods:
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Treatment phase: randomized patients will be treated for 28 days
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Safety follow-up phase of 14 days after which the End of Study visit (EOS) will be performed.
Study Design
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
- 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
- Rate of patients hospitalized [28-day treatment period]
- 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
- 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]
- Rate of patients requiring oxygen supplementation [28-day treatment period]
- Time to hospitalization [28-day treatment period]
- Time to assisted ventilation and oxygen supplementation [28-day treatment period]
- Change from baseline in microRNA-124 levels [at each study visit during the 28-day treatment period]
- Change from baseline in CRP, Troponin I & T and D-dimer [at each study visit during the 28-day treatment period]
- SARS-CoV-2 viral load [at each study visit during the 28-day treatment period]
Nasopharyngeal sample and/or in blood
- Number and rates of participants with Treatment Emergent Adverse Event [28-day treatment period]
Eligibility Criteria
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:
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Age ≥ 65 years
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Obesity defined as BMI ≥ 30
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Recent history of uncontrolled High Blood Pressure (SBP > 150 mm Hg DBP >100 mm Hg) according to investigator
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Treated diabetes (type I or II)
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History of ischemic cardiovascular disease
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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.
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Patients with pulse oximetry arterial saturation ≥ 92 % on room air at enrolment.
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Patients with the following hematological and biochemical laboratory parameters obtained within 7 days prior to Day 0:
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Hemoglobin above 9.0 g / dL
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Absolute Neutrophil Count ≥ 1000 / mm3
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Platelets ≥ 100 000 mm3;
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Creatinine clearance ≥ 50 mL / min by the Cockcroft Gault formula
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Total serum bilirubin < 2 x ULN
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Alkaline phosphatase < 2 x ULN, AST (SGOT) and ALT (SGPT) < 3 x ULN;
Exclusion Criteria:
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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).
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Patients treated with immunosuppressors and/or immunomodulators.
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Engrafted patients (organ and/or hematopoietic stem cells).
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Patients with uncontrolled auto-immune disease.
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Patients with known or suspected active (i.e. not controlled) bacterial, viral (excluding COVID-19) or fungal infections.
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Patients with preexisting, severe and not controlled organ failure.
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History or active malignancy requiring chemotherapy or radiation therapy (excluding 2 years disease free survivor patients).
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Pregnant or breast-feeding women.
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Illicit drug or alcohol abuse or dependence that may compromise the patient's safety or adherence to the study protocol.
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Use of any investigational or non-registered product within 3 months or within 5 half-lives preceding baseline, whichever is longer.
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Hypersensitivity to ABX464 and/or its excipients.
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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 | |
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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.- ABX464-401