Asunercept in Patients With Severe COVID-19
- Conditions
- COVID-19 Induced PneumoniaCovid19
- Interventions
- Biological: Asunercept
- Registration Number
- NCT04535674
- Lead Sponsor
- Apogenix AG
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 438
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard of Care + Asunercept 400 mg Asunercept - Standard of Care + Asunercept 25 mg Asunercept - Standard of Care + Asunercept 100 mg Asunercept -
- Primary Outcome Measures
Name Time Method Time to sustained improvement of one category (i.e. two consecutive days) from randomisation Day 1-29 The primary endpoint is time to clinical improvement which is defined as time from randomisation to an (sustained) improvement of at least one category on two consecutive days compared to the status at randomisation measured on a nine-category ordinal scale (proposed by WHO).
- Secondary Outcome Measures
Name Time Method Efficacy according to the National Early Warning Score (NEWS) Day 1-29 Time to discharge or to a NEWS of ≤2 and maintained for 24 hours, whichever occurs first Change from baseline
Oxygenation Day 1-29 Oxygenation free days until day 29 Incidence and duration of new oxygen use during the trial
Ventilation Day 1-29 Ventilator free days until day 29 Incidence and duration fo new mechanical ventilation use during the trial
Hospitalisation - Length Day 1-29 Duration of hospitalisation Length of ICU stay (in days)
Hospitalisation - Proportion on ICU Day 1-29 Proportion of patients admitted to ICU
Mortality Up to 90 days 15-day, 29-day, 60-day and 90-day all-cause mortality
Trial Locations
- Locations (13)
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
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
Hospital Universitario Ramón y Cajal
🇪🇸Madrid, Spain
Saint Petersburg state budgetary healthcare institution "City hospital of Saint George the great Martyr"
🇷🇺Saint Petersburg, Russian Federation
Hospital Universitario Puerta de Hierro Majadahonda
🇪🇸Majadahonda, Spain
Hospital Clínico Universitario Lozano Blesa
🇪🇸Zaragoza, Spain
Hospital Universitario La Paz
🇪🇸Madrid, Spain
Ryazan State Medical University n.a. academician I.P. Pavlov
🇷🇺Ryazan, Russian Federation
Hospital Universitario Infanta Leonor
🇪🇸Madrid, Spain
Hospital Universitario Infanta Sofia
🇪🇸San Sebastián De Los Reyes, Spain