This clincial trial is a prospective, multicenter, randomized, double-blind, placebo-controlled Phase III trial in hospitalized patients with moderate to severe COVID-19 corresponding to score 5 or 6 on the WHO 10-point clinical progression scale (Grade 0-10). The investigational drug (APG101; International Nonproprietary Name: asunercept) will be given at a dose of 100 mg intravenously (i.v.) once weekly for a period of 4 weeks (1 dose each on d1, d8, d15, and d22) in addition to the treatment recommended by international, national, or local treatment guidelines (SoC) and will be compared with the control arm (i.e., SoC + placebo).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
34
Asunercept (APG101) will be administered once per week as an i.v. infusion
Placebo will be administered once per week as an i.v. infusion
Univeritätsklinik für Innere Medizin I
Vienna, Austria
CHU Amiens - Site Sud, Centre de Recherche Clinique
Amiens, France
Dubois Hospital, Service de médecine intensive Réanimation
Brive-la-Gaillarde, France
CHU de Limoges - Hopital Dupuytren
Limoges, France
Georges Pompidou European Hospital
Paris, France
Time to sustained recovery
Sustained improvement (i.e., without decrease) of ≥2 points on the WHO 10 point clinical progression scale or discharge from hospital followed by being alive and at home for 14 consecutive days prior to day (d) 56, whichever occurs first.
Time frame: Day 1-56
Efficacy in reducing progression to more severe disease or death
All-cause mortality or progression to invasive mechanical ventilation (IMV) by d28
Time frame: Day 1-28
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Ltd "Hospital Service"
Kutaisi, Georgia
Ltd "Academician Nikoloz Kipshidze Central University Clinic"
Tbilisi, Georgia
Ltd "Academician Vakhtang Bochorishvili Clinic"
Tbilisi, Georgia
Ltd "TSMU and Ingorokva High Medical Technology University Clinic"
Tbilisi, Georgia
Uniklinik Köln - Klinik I für Innere Medizin
Cologne, Germany
...and 29 more locations