COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04393038

Eric CUA, MD

Paul GINESTE, paul.gineste@abivax.com (PI email not reported)

2020-05-19

Terminated

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

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;

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.

2

Abivax S.A.

18

None

Belgium;Brazil;France;Germany;Italy;Mexico;Spain;United Kingdom

Mild disease at enrollment

1: Mild disease at enrollment

509

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

None

Phase 2/Phase 3

[{"arm_notes": "Results available for 2020-001673-75 on : https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-001673-75/results", "treatment_id": 11, "treatment_name": "Abx464", "treatment_type": "Anti-inflammatories", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "Results available for 2020-001673-75 on : https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-001673-75/results", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]