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

Apogenix

Status and phase

Terminated

Phase 3

Conditions

COVID-19

Treatments

Other: Placebo

Biological: Asunercept

Study type

Interventional

Funder types

Industry

Identifiers

NCT05639192

APG101_CD_018

Details and patient eligibility

About

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).

Enrollment

34 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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).