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Trial record 4 of 13 for:    ABX464

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

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ClinicalTrials.gov Identifier: NCT04393038
Recruitment Status : Recruiting
First Posted : May 19, 2020
Last Update Posted : July 9, 2020
Sponsor:
Information provided by (Responsible Party):
Abivax S.A.

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
COVID-19 Drug: ABX464 Drug: Placebo 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1034 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Phase 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 : May 1, 2020
Estimated Primary Completion Date : December 30, 2020
Estimated Study Completion Date : April 30, 2021

Resource links provided by the National Library of Medicine


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




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 [ Time Frame: at the end of the 28-day treatment period ]

Secondary Outcome Measures :
  1. Rate of patients hospitalized [ Time Frame: 28-day treatment period ]
  2. Percentage of patients reporting each severity rating on a 7-point ordinal scale [ Time Frame: 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 [ Time Frame: at each study visit during the 28-day treatment period ]
  4. Rate of patients requiring oxygen supplementation [ Time Frame: 28-day treatment period ]
  5. Time to hospitalization [ Time Frame: 28-day treatment period ]
  6. Time to assisted ventilation and oxygen supplementation [ Time Frame: 28-day treatment period ]
  7. Change from baseline in microRNA-124 levels [ Time Frame: at each study visit during the 28-day treatment period ]
  8. Change from baseline in CRP, Troponin I & T and D-dimer [ Time Frame: at each study visit during the 28-day treatment period ]
  9. SARS-CoV-2 viral load [ Time Frame: 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 [ Time Frame: 28-day treatment period ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  2. 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.
  3. Patients with pulse oximetry arterial saturation ≥ 92 % on room air at enrolment.
  4. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04393038


Contacts
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Contact: Paul GINESTE +33 625830783 paul.gineste@abivax.com
Contact: Anais Vissian anais.vissian@abivax.com

Locations
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Sponsors and Collaborators
Abivax S.A.
Investigators
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Principal Investigator: Eric CUA, MD Centre Hospitalier Universitaire de Nice
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Responsible Party: Abivax S.A.
ClinicalTrials.gov Identifier: NCT04393038    
Other Study ID Numbers: ABX464-401
First Posted: May 19, 2020    Key Record Dates
Last Update Posted: July 9, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Abivax S.A.:
COVID-19
ABX464
Additional relevant MeSH terms:
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Respiratory Insufficiency
Inflammation
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases