Asunercept in Patients With Severe COVID-19 (ASUNCTIS)

Apogenix

Status and phase: Completed; Phase 2

Conditions: Covid19; COVID-19 Induced Pneumonia

Treatments: Biological: Asunercept

Study type: Interventional

Funder types: Industry

Identifiers

NCT04535674

2020-001887-27 (EudraCT Number)

APG101_CD_017

Details and patient eligibility

About

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.

Enrollment: 438 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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438 participants in 4 patient groups

Standard of Care

No Intervention group

Standard of Care + Asunercept 25 mg

Experimental group

Treatment:

Biological: Asunercept

Standard of Care + Asunercept 100 mg

Experimental group

Treatment:

Biological: Asunercept

Standard of Care + Asunercept 400 mg

Experimental group

Treatment:

Biological: Asunercept