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Asunercept for the Treatment of Patients With Moderate to Severe COVID-19 Disease (ASUCOV)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT05639192
Recruitment Status : Recruiting
First Posted : December 6, 2022
Last Update Posted : December 8, 2022
Information provided by (Responsible Party):
Apogenix AG

Brief Summary:

This clincial trial is a prospective, multicenter, randomized, double-blind, placebo-controlled Phase III trial in hospitalized patients with moderate to severe COVID-19 corresponding to score 5 or 6 on the WHO 10-point clinical progression scale (Grade 0-10).

The investigational drug (APG101; International Nonproprietary Name: asunercept) will be given at a dose of 100 mg intravenously (i.v.) once weekly for a period of 4 weeks (1 dose each on d1, d8, d15, and d22) in addition to the treatment recommended by international, national, or local treatment guidelines (SoC) and will be compared with the control arm (i.e., SoC + placebo).

Condition or disease Intervention/treatment Phase
COVID-19 Biological: Asunercept Other: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 636 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Placebo-controlled, Double-blind, Phase III Trial to Evaluate the Efficacy of Asunercept for the Treatment of Hospitalized Patients With Moderate to Severe COVID 19 Disease
Actual Study Start Date : November 3, 2022
Estimated Primary Completion Date : November 30, 2023
Estimated Study Completion Date : November 30, 2023

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Standard of Care + Asunercept 100 mg Biological: Asunercept
Asunercept (APG101) will be administered once per week as an i.v. infusion

Placebo Comparator: Standard of Care + Placebo Other: Placebo
Placebo will be administered once per week as an i.v. infusion

Primary Outcome Measures :
  1. Time to sustained recovery [ Time Frame: Day 1-56 ]
    Sustained improvement (i.e., without decrease) of ≥2 points on the WHO 10 point clinical progression scale or discharge from hospital followed by being alive and at home for 14 consecutive days prior to day (d) 56, whichever occurs first.

Secondary Outcome Measures :
  1. Efficacy in reducing progression to more severe disease or death [ Time Frame: Day 1-28 ]
    All-cause mortality or progression to invasive mechanical ventilation (IMV) by d28

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patient must be willing and able to give informed consent to participate in the trial and to adhere to the procedures stated in the protocol
  • ≥18 years of age
  • Patient is admitted to a hospital (max. 72 hours prior to randomization) due to COVID-19 and has a positive SARS-CoV-2 PCR test
  • Clinical symptoms indicative of moderate or severe illness (corresponding to score 5 or 6 on the WHO 10-point clinical progression scale) with COVID 19 prior to trial treatment
  • Patient agrees to not participate in another clinical trial from screening until day 56

Exclusion Criteria:

  • Patient is moribund or has an estimated life expectancy <1 month (e.g., terminal cancer, etc.)
  • Patient is anticipated to be discharged from hospital within 48 hours
  • Patient requires anti-inflammatory medicines beyond SoC (SoC are drugs that are approved for treatment of COVID-19 as well as medicines that have been recommended in treatment guidelines of national health authorities and/or professional organization)
  • Patient requires invasive mechanical ventilation
  • Patient is known to have active tuberculosis
  • Patient is known to have hereditary fructose intolerance.
  • Patient is known to have co-infection with Influenza viruses or other viral respiratory infections (respiratory syncytial virus [RSV], parainfluenza viruses, respiratory adenoviruses).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05639192

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Contact: Eike C. Buss, MD +49 6221 586080 contact@apogenix.com

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Sponsors and Collaborators
Apogenix AG
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Study Chair: Eike C. Buss, MD Apogenix AG
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Responsible Party: Apogenix AG
ClinicalTrials.gov Identifier: NCT05639192    
Other Study ID Numbers: APG101_CD_018
First Posted: December 6, 2022    Key Record Dates
Last Update Posted: December 8, 2022
Last Verified: November 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Respiratory Tract Infections
Pneumonia, Viral
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases