ASUCOV: Asunercept for the Treatment of Patients With Moderate to Severe COVID-19 Disease
Study Details
Study Description
Brief Summary
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).
Condition or Disease | Intervention/Treatment | Phase |
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Phase 3 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Standard of Care + Asunercept 100 mg
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Biological: Asunercept
Asunercept (APG101) will be administered once per week as an i.v. infusion
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Placebo Comparator: Standard of Care + Placebo
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Other: Placebo
Placebo will be administered once per week as an i.v. infusion
|
Outcome Measures
Primary Outcome Measures
- Time to sustained recovery [Day 1-56]
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.
Secondary Outcome Measures
- Efficacy in reducing progression to more severe disease or death [Day 1-28]
All-cause mortality or progression to invasive mechanical ventilation (IMV) by d28
Eligibility Criteria
Criteria
Inclusion Criteria:
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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
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≥18 years of age
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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
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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
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Patient agrees to not participate in another clinical trial from screening until day 56
Exclusion Criteria:
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Patient is moribund or has an estimated life expectancy <1 month (e.g., terminal cancer, etc.)
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Patient is anticipated to be discharged from hospital within 48 hours
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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)
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Patient requires invasive mechanical ventilation
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Patient is known to have active tuberculosis
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Patient is known to have hereditary fructose intolerance.
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Patient is known to have co-infection with Influenza viruses or other viral respiratory infections (respiratory syncytial virus [RSV], parainfluenza viruses, respiratory adenoviruses).
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Univeritätsklinik für Innere Medizin I | Wien | Austria | ||
2 | CHU Amiens - Site Sud, Centre de Recherche Clinique | Amiens | France | ||
3 | CHU de Limoges - Hopital Dupuytren | Limoges | France | ||
4 | Georges Pompidou European Hospital | Paris | France | ||
5 | Ltd "Hospital Service" | Kutaisi | Georgia | ||
6 | LEPL "The first University Clinic of TSMU" | Tbilisi | Georgia | ||
7 | Ltd "Academician Nikoloz Kipshidze Central University Clinic" | Tbilisi | Georgia | ||
8 | Ltd "Academician Vakhtang Bochorishvili Clinic" | Tbilisi | Georgia | ||
9 | Ltd "TSMU and Ingorokva High Medical Technology University Clinic" | Tbilisi | Georgia | ||
10 | Universitätsklinikum Heidelberg | Heidelberg | Germany | ||
11 | Uniklinik Köln - Klinik I für Innere Medizin | Köln | Germany | ||
12 | King George Hospital | Visakhapatnam | Andrha Pradesh | India | |
13 | Citizen Hospital | Bangalore | Karnataka | India | |
14 | JSS Hospital | Mysore | Karnataka | India | |
15 | Spandan Hospital | Pune | Maharashta | India | |
16 | Govtl. Medical College and Hospital Aurangabad | Aurangabad | Maharashtra | India | |
17 | PCMC PGI Yashwantrao Chavan Memorial Hospital | Pune | Maharashtra | India | |
18 | Atharva Multispecialty Hospital and Research Center | Lucknow | Uttar Pradesh | India | |
19 | Victoria Hospital, BMCRI Bangalore Medical College & Research Institute | Bangalore | India | ||
20 | KLES Dr. Prabhakar Kore Hospital & Medical Research Center | Nehru Nagar | India | ||
21 | Unity Hospital | Sūrat | India | ||
22 | ASST Fatebenefratelli Sacco | Milano | Italy | ||
23 | ASST Santi Paolo e Carlo | Milan | Italy | ||
24 | Azienda Ospedaliera Universitaria L. Vanvitelli | Napoli | Italy | ||
25 | Azienda Ospedaliere Universitaria Federico I | Napoli | Italy | ||
26 | ZOZ w Boleslawcu | Bolesławiec | Poland | ||
27 | Nicolaus Copernicus Hospital | Koszalin | Poland | ||
28 | Regional Specialist Hospital | Wrocław | Poland | ||
29 | Lakeview Hospital | Benoni | South Africa | ||
30 | Helen Joseph Hospital | Johannesburg | South Africa | ||
31 | FCRN Clinical Trials Centre | Three Rivers | South Africa | ||
32 | Hospital General Universitario de Alicante Dr. Balmis | Alicante | Spain | ||
33 | Hospital del Mar | Barcelona | Spain | ||
34 | Complejo Asistencial Universitario de Salamanca | Salamanca | Spain | ||
35 | Hospital Universitario Río Hortega | Valladolid | Spain | ||
36 | Complejo Hospitalario Universitario de Vigo - Hospital Álvaro Cunqueiro | Vigo | Spain |
Sponsors and Collaborators
- Apogenix AG
Investigators
- Study Chair: Eike C. Buss, MD, Apogenix AG
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- APG101_CD_018