COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT05639192

Not reported

Not reported

2022-12-06

Terminated

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

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

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).

2

Apogenix GmbH

18

100

Austria;France;Georgia;Germany;India;Italy;Poland;South Africa;Spain

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

34

Time to sustained recovery

None

Phase 3

[{"arm_notes": "nan", "treatment_id": 132, "treatment_name": "Asunercept", "treatment_type": "Other targeted therapies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "nan", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]