Asunercept for the Treatment of Patients With Moderate to Severe COVID-19 Disease (ASUCOV)
COVID-19
About this trial
This is an interventional treatment trial for COVID-19
Eligibility Criteria
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).
Sites / Locations
- Univeritätsklinik für Innere Medizin I
- CHU Amiens - Site Sud, Centre de Recherche Clinique
- Dubois Hospital, Service de médecine intensive Réanimation
- CHU de Limoges - Hopital Dupuytren
- Georges Pompidou European Hospital
- Ltd "Hospital Service"
- Ltd "Academician Nikoloz Kipshidze Central University Clinic"
- Ltd "Academician Vakhtang Bochorishvili Clinic"
- Ltd "TSMU and Ingorokva High Medical Technology University Clinic"
- Universitätsklinikum Heidelberg
- Uniklinik Köln - Klinik I für Innere Medizin
- King George Hospital
- Citizen Hospital
- JSS Hospital
- Spandan Hospital
- Govtl. Medical College and Hospital Aurangabad
- PCMC PGI Yashwantrao Chavan Memorial Hospital
- Ashirwad Hospital and Research Centre
- Atharva Multispecialty Hospital and Research Center
- Victoria Hospital, BMCRI Bangalore Medical College & Research Institute
- KLES Dr. Prabhakar Kore Hospital & Medical Research Center
- Unity Hospital
- ASST Fatebenefratelli Sacco
- ASST Santi Paolo e Carlo
- Azienda Ospedaliera Universitaria L. Vanvitelli
- Azienda Ospedaliere Universitaria Federico I
- ZOZ w Boleslawcu
- Nicolaus Copernicus Hospital
- Regional Specialist Hospital
- Global Clinical Trials
- Lakeview Hospital
- Synapta Clinical Research, 704 Durban Medical Centre
- Helen Joseph Hospital
- FCRN Clinical Trials Centre
- Hospital General Universitario de Alicante Dr. Balmis
- Hospital del Mar
- Complejo Asistencial Universitario de Salamanca
- Hospital Universitario Río Hortega
- Complejo Hospitalario Universitario de Vigo - Hospital Álvaro Cunqueiro
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Standard of Care + Asunercept 100 mg
Standard of Care + Placebo