Moderate to Severe COVID-19 Disease MedDRA version: 23.1 Level: LLT Classification code 10084401 Term: COVID-19 respiratory infection System Organ Class: 100000004862
Conditions
Interventions
Product Name: Asunercept
Product Code: APG101
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Asunercept
CAS Number: 1450882-18-4
Current Sponsor code: APG101
Concentra
Sponsors
Apogenix AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The 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 2. The patient is a male or female adult aged =18 years at the time of giving informed consent 3. The patient is admitted to a hospital (maximum 72 hours prior to randomization) due to COVID-19 and has a positive SARS-CoV-2 PCR test 4. The patient has clinical symptoms indicative of moderate or severe illness (corresponding to score 5 [oxygen by mask or nasal prongs] or 6 [oxygen by non-invasive ventilation or high flow] on the WHO 10-point clinical progression scale) with COVID-19 prior to trial treatment on d1: Radiologically confirmed pneumonia due to COVID-19 and/ or clinical signs suggestive of moderate/severe illness with COVID-19 5. The patient agrees to not participate in another clinical trial from screening until d56 6. The patient is willing to follow effective measures of contraception during the trial Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 512 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 128
Exclusion criteria
Exclusion criteria: 1. The patient is moribund or has an estimated life expectancy <1 month 2. The patient is pregnant or breastfeeding 3. The patient is anticipated to be discharged from hospital within 48 hrs 4. The patient requires anti-inflammatory medicines beyond SoC (SoC are drugs that are approved for treatment of COVID-19. In addition, SoC comprises medicines that have been recommended in treatment guidelines of national health authorities and/or professional organization) 5. The patient requires invasive mechanical ventilation 6. The patient is known to have active tuberculosis 7. The patient is known to have hereditary fructose intolerance 8. The patient is known to have co-infection with Influenza viruses or other viral respiratory infections
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To estimate the efficacy of Asunercept in the treatment of hospitalized patients with moderate to severe COVID-19 when given as add on to Standard of Care;Secondary Objective: To estimate the efficacy of Asunercept when given as add on to Standard of Care in reducing progression to more severe disease (i.e., invasive mechanical ventilation) or death;Primary end point(s): Time to sustained recovery, defined as 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;Timepoint(s) of evaluation of this end point: Day 1 to 28, 35, 42, 49 & 56 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): All-cause mortality or progression to invasive mechanical ventilation (IMV) by d28;Timepoint(s) of evaluation of this end point: Day 1 to 28 | — |
Countries
Austria, France, Georgia, Germany, India, Italy, Poland, South Africa, Spain
Contacts
Public ContactSponsor’s Medical Expert
Apogenix AG
Outcome results
None listed