Clinical trial NCT04535674: Asunercept in Patients With Severe COVID-19
Official title: A Multicenter, Randomised, Controlled, Open Label Trial on the Efficacy and Safety of Asunercept for Patients With Severe COVID-19 Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: COVID-19 Induced Pneumonia
Covid19
Lead sponsor: Apogenix AG
Sponsor class: INDUSTRY
First posted: 2020-09-02
Enrollment: 438
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Asunercept/APG101 will be tested in three parallel intervention arms and compared with Standard of Care (SoC). The study will compare treatment efficacy of SoC to that of weekly intravenous infusions of Asunercept at three different doses. Patients will be randomised into four groups.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Time to sustained improvement of one category (i.e. two consecutive days) from randomisation
timeFrame: Day 1-29
Secondary outcomes:
measure: Efficacy according to the National Early Warning Score (NEWS)
timeFrame: Day 1-29
measure: Oxygenation
timeFrame: Day 1-29
measure: Ventilation
timeFrame: Day 1-29
measure: Hospitalisation - Length
timeFrame: Day 1-29
measure: Hospitalisation - Proportion on ICU
timeFrame: Day 1-29
measure: Mortality
timeFrame: Up to 90 days
Other outcomes:
Locations:
city: Kazan
country: Russian Federation
facility: Republican Clinical Infectious Hospital n.a. professor A.F. Agafonov
city: Kemerovo
country: Russian Federation
facility: Scientific Research lnstitute fоr Соmрlех lssues of Cardiovascular Diseases
city: Krasnodar
country: Russian Federation
facility: Federal State Budgetary Educational Institution of Higher Education "Kuban State Medical University" of the Ministry of Health of the Russian Federation
city: Krasnodar
country: Russian Federation
facility: 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
city: Nizhny Novgorod
country: Russian Federation
facility: State Budgetary Institution of Health of the Nizhny Novgorod Region "Infectious Clinical Hospital No. 2 of Nizhny Novgorod"
city: Ryazan
country: Russian Federation
facility: Ryazan State Medical University n.a. academician I.P. Pavlov
city: Saint Petersburg
country: Russian Federation
facility: Saint Petersburg state budgetary healthcare institution "City hospital of Saint George the great Martyr"
city: Madrid
country: Spain
facility: Hospital Universitario Infanta Leonor
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro Majadahonda
city: San Sebastián De Los Reyes
country: Spain
facility: Hospital Universitario Infanta Sofia
city: Zaragoza
country: Spain
facility: Hospital Clínico Universitario Lozano Blesa
Study officials:
affiliation: Hospital Universitario Infanta Sofía, Madrid
name: Pilar Ruiz-Seco, PhD-MD
role: PRINCIPAL_INVESTIGATOR
References: