NCT04535674: ASUNCTIS

Asunercept in Patients With Severe COVID-19

Completed Phase 2 Last updated 14 January 2022

What this trial tests

Phase 2 trial testing Asunercept in COVID-19 Induced Pneumonia in 438 participants. Completed in 21 December 2021.

Timeline

9 October 2020

Primary endpoint
29 October 2021

21 December 2021

Quick facts

Lead sponsor	Apogenix AG
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	438
Start date	9 October 2020
Primary completion	29 October 2021
Estimated completion	21 December 2021
Sites	13 locations across Russia, Spain

Drugs / interventions tested

• Asunercept — full drug profile →

Conditions studied

• COVID-19 Induced Pneumonia — all drugs for COVID-19 Induced Pneumonia →
• Covid19 — all drugs for Covid19 →

Sponsor

Apogenix AG

Who can join

18 and older, any sex, with COVID-19 Induced Pneumonia or Covid19. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. SARS-CoV-2-associated lymphopenia: possible mechanisms and the role of CD147.
   Shouman S, El-Kholy N, Hussien AE, El-Derby AM, et al · · 2024 · cited 23× · PMID 38965547 · DOI 10.1186/s12964-024-01718-3
2. Role of metalloproteases in the CD95 signaling pathways.
   Devel L, Guedeney N, Bregant S, Chowdhury A, et al · · 2022 · cited 12× · PMID 36544756 · DOI 10.3389/fimmu.2022.1074099
3. Efficacy and safety of asunercept, a CD95L-selective inhibitor, in hospitalised patients with moderate-to-severe COVID-19: ASUNCTIS, a multicentre, randomised, open-label, controlled, phase 2 trial.
   Ruiz Seco MP, Paño Pardo JR, Schoergenhofer C, Dings C, et al · · 2024 · cited 2× · PMID 39513186 · DOI 10.1016/j.eclinm.2024.102879