Asunercept for the Treatment of Patients With Moderate to Severe COVID-19 Disease

Study Overview
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Brief Summary
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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).

Official Title
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A Multicenter, Randomized, Placebo-controlled, Double-blind, Phase III Trial to Evaluate the Efficacy of Asunercept for the Treatment of Hospitalized Patients With Moderate to Severe COVID 19 Disease

Conditions
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COVID-19

Intervention / Treatment
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* Biological: Asunercept
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient must be willing and able to give informed consent to participate in the trial and to adhere to the procedures stated in the protocol ≥18 years of age Patient is admitted to a hospital (max. 72 hours prior to randomization) due to COVID-19 and has a positive SARS-CoV-2 PCR test Clinical symptoms indicative of moderate or severe illness (corresponding to score 5 or 6 on the WHO 10-point clinical progression scale) with COVID 19 prior to trial treatment Patient agrees to not participate in another clinical trial from screening until day 56 Exclusion Criteria: Patient is moribund or has an estimated life expectancy <1 month (e.g., terminal cancer, etc.) Patient is anticipated to be discharged from hospital within 48 hours Patient requires anti-inflammatory medicines beyond SoC (SoC are drugs that are approved for treatment of COVID-19 as well as medicines that have been recommended in treatment guidelines of national health authorities and/or professional organization) Patient requires invasive mechanical ventilation Patient is known to have active tuberculosis Patient is known to have hereditary fructose intolerance. Patient is known to have co-infection with Influenza viruses or other viral respiratory infections (respiratory syncytial virus [RSV], parainfluenza viruses, respiratory adenoviruses).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Standard of Care + Asunercept 100 mg<br> | Biological: Asunercept<br>* Asunercept (APG101) will be administered once per week as an i.v. infusion<br>|
| Placebo Comparator: Standard of Care + Placebo<br> | Other: Placebo<br>* Placebo will be administered once per week as an i.v. infusion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Day 1-56 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy in reducing progression to more severe disease or death | All-cause mortality or progression to invasive mechanical ventilation (IMV) by d28 | Day 1-28 |