This is an open-label, randomized, phase II study with the main objective to investigate the effectiveness and safety of an investigational drug (APG101; International Nonproprietary Name: asunercept) in patients with severe COVID-19 disease. The study aims to decrease overall and SARS-CoV-2 associated pneumonia mortality in patients with COVID-19 as well as to decrease the percentage of patients admitted to Intensive Care Unit (ICU), decrease the need to supply oxygen to patients, reduce the number of days patients are hospitalized in ICU and/or on the ward, decrease the number of days required to obtain a negative result in the PCR (Polymerase Chain Reaction, a laboratory technique that allows the amplification of small fragments of DNA to detect the presence of the virus) test for COVID-19 and decrease the levels of markers that indicate pneumonia.
Biological: Asunercept
Asunercept (APG101) will be administered once per week as an i.v. infusion
Inclusion Criteria:
- Laboratory confirmed infection with SARS-CoV-2 OR typical radiological signs of
SARS-CoV-2 infection
- Hospitalisation due to COVID-19
- Informed Consent obtained, the patient understands and agrees to comply with the
planned study procedures. If a potential patient is unconscious, the Patient
Information Sheet with the Informed Consent Form can be signed by the legal
representative, if he/she accompanies the patient. It can be signed by a Concilium
consisting of doctors (2), investigator and an independent witness in case the legal
representative is not available.
- ≥18 years of age
- Willingness to perform effective measures of contraception during the study.
- Signs of respiratory deterioration such as oxygen saturation ≤94% when breathing
ambient air or >3% drop in oxygen saturation in case of chronic obstructive lung
disease OR need for oxygen supplementation to achieve satisfactory blood oxygen
saturation (sPO2>90% at room air) as well as the need for non-invasive ventilation,
high-flow oxygen devices or mechanical ventilation or radiological or clinical signs
of pneumonia.
Exclusion Criteria:
- Moribund, or estimated life expectancy <1 month (e.g., terminal cancer, etc.)
- Patient does not qualify for intensive care, based on local triage criteria
- Pregnancy or breast feeding
- Severe liver dysfunction (e.g. ALT/AST > 5 times upper limit of normal)
- Anticipated discharge from hospital within 48 hours
- Other potent anti-inflammatory treatment, e.g. TNF- blocking therapies
- Mechanical ventilation for >48 hours
- Known active HIV or viral hepatitis infection
- Known active tuberculosis
- Known hereditary fructose intolerance
Republican Clinical Infectious Hospital n.a. professor A.F. Agafonov
Kazan, Russian Federation
Scientific Research lnstitute fоr Соmрlех lssues of Cardiovascular Diseases
Kemerovo, Russian Federation
Federal State Budgetary Educational Institution of Higher Education "Kuban State Medical University" of the Ministry of Health of the Russian Federation
Krasnodar, Russian Federation
State Budgetary Healthcare Institution "Scientific Research Institute - Regional clinical hospital No. 1 n.a. professor S.V. Ochapovsky" of the Ministry of Healthcare of Krasnodar Krai
Krasnodar, Russian Federation
State Budgetary Institution of Health of the Nizhny Novgorod Region "Infectious Clinical Hospital No. 2 of Nizhny Novgorod"
Nizhny Novgorod, Russian Federation
Ryazan State Medical University n.a. academician I.P. Pavlov
Ryazan, Russian Federation
Saint Petersburg state budgetary healthcare institution "City hospital of Saint George the great Martyr"
Saint Petersburg, Russian Federation
Hospital Universitario Infanta Leonor
Madrid, Spain
Hospital Universitario La Paz
Madrid, Spain
Hospital Universitario Ramón y Cajal
Madrid, Spain
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, Spain
Hospital Universitario Infanta Sofia
San Sebastián De Los Reyes, Spain
Hospital Clínico Universitario Lozano Blesa
Zaragoza, Spain
Pilar Ruiz-Seco, PhD-MD, Principal Investigator
Hospital Universitario Infanta Sofía, Madrid