Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: Asunercept: APG101 (Asunercept) is a recombinant glycosylated fusion protein consisting of the extracellular
domain of human CD95 linked to the Fc domain of human IgG1 (CD95-Fc). Two C
Sponsors
Apogenix AG
Pharm Olam International India Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: The patient or his/her legal authorized representative (in case the patient is unable to give own consent due to his/her medical condition) has given informed consent to participate in the trial and to adhere to the procedures stated in the protocol. The patient is a male or female adult aged >=18 years at the time of giving informed consent. The patient is admitted to a hospital (maximum 72 hours prior to randomization) due to COVID-19 and has a positive SARS-CoV-2 polymerase chain reaction (PCR) test. 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. The patient is willing to follow effective measures of contraception during the trial.
Exclusion criteria
Exclusion criteria: The patient is moribund or has an estimated life expectancy The patient is pregnant or breastfeeding. The patient is anticipated to be discharged from hospital within 48 hours. 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). The patient requires invasive mechanical ventilation. The patient is known to have active tuberculosis. The patient is known to have hereditary fructose intolerance. The patient is known to have co-infection with Influenza viruses or other viral respiratory infections (respiratory syncytial virus [RSV], parainfluenza viruses, respiratory adenoviruses). The patient was or is currently participating in any investigational clinical study, other than observational, within 30 days prior to enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to sustained recovery, defined as sustained improvement (i.e., without decrease) of â?¥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: 14 consecutive days prior to day (d) 56, whichever occurs first | — |
Secondary
| Measure | Time frame |
|---|---|
| All-cause mortality or progression to invasive mechanical ventilation (IMV) by d28Timepoint: 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 ContactThanuja Naidu
Director Clinical Operations APAC and Country Manager India
Outcome results
None listed