ABX464 in Treating Inflammation and Preventing Acute Respiratory Failure in Patients With COVID-19 (NCT04393038) | Clinical Trial Compass
TerminatedPhase 2/3
ABX464 in Treating Inflammation and Preventing Acute Respiratory Failure in Patients With COVID-19
Stopped: Interim analysis concludes that the study is futile
Belgium, Brazil509 participantsStarted 2020-07-01
Plain-language 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).
Who can participate
Age range18 Years
SexALL
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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:
✓. 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:
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.
✕. 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.
✕
What they're measuring
1
Rate of Responders: i.e. Rate of Patients Who do Not Require Use of High-flow Oxygen Invasive or Non-invasive Mechanical Ventilation (IMV and NIV, Respectively) Within 28 Days and Who Are Alive at the End of the 28 Days Period.