Asunercept in Patients With Severe COVID-19

Covid19 Clinical Trial

— ASUNCTIS  

Official title:

A Multicenter, Randomised, Controlled, Open Label Trial on the Efficacy and Safety of Asunercept for Patients With Severe COVID-19 Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04535674
• Other study ID #: APG101_CD_017
• Secondary ID: 2020-001887-27
• Status: Completed
• Phase: Phase 2
• Start date: October 9, 2020
• Est. completion date: December 21, 2021

Study information

• Verified date: July 2021
• Source: Apogenix AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 438
• Est. completion date: December 21, 2021
• Est. primary completion date: October 29, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• COVID-19 Induced Pneumonia
• Covid19

Intervention

Biological:
• Asunercept
Asunercept (APG101) will be administered once per week as an i.v. infusion

Locations

Country	Name	City	State
Russian Federation	Republican Clinical Infectious Hospital n.a. professor A.F. Agafonov	Kazan
Russian Federation	Scientific Research lnstitute f?r ??m?l?? 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
Spain	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

Sponsors (1)

Lead Sponsor	Collaborator
Apogenix AG

Countries where clinical trial is conducted

Russian Federation,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to sustained improvement of one category (i.e. two consecutive days) from randomisation	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).	Day 1-29
Secondary	Efficacy according to the National Early Warning Score (NEWS)	Time to discharge or to a NEWS of =2 and maintained for 24 hours, whichever occurs first Change from baseline	Day 1-29
Secondary	Oxygenation	Oxygenation free days until day 29 Incidence and duration of new oxygen use during the trial	Day 1-29
Secondary	Ventilation	Ventilator free days until day 29 Incidence and duration fo new mechanical ventilation use during the trial	Day 1-29
Secondary	Hospitalisation - Length	Duration of hospitalisation Length of ICU stay (in days)	Day 1-29
Secondary	Hospitalisation - Proportion on ICU	Proportion of patients admitted to ICU	Day 1-29
Secondary	Mortality	15-day, 29-day, 60-day and 90-day all-cause mortality	Up to 90 days