Status:
TERMINATED
ABX464 in Treating Inflammation and Preventing Acute Respiratory Failure in Patients With COVID-19
Lead Sponsor:
Abivax S.A.
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
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...
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. El...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 16 2021
Estimated Enrollment :
509 Patients enrolled
Trial Details
Trial ID
NCT04393038
Start Date
July 1 2020
End Date
April 16 2021
Last Update
November 26 2025
Active Locations (30)
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1
Centre hospitalier Saint Pierre
Brussels, Belgium, 1000
2
Hôpital Erasme
Brussels, Belgium, 1070
3
UZ Gent
Ghent, Belgium, 9000
4
Fundacao de Medicina Tropical Doutor Heitor Vieira Dourado - Instituto de Pesquisa Clínica Carlos Borborema
Manaus, Amazonas, Brazil, 69040-000