COVID-19 trials registries data warehouse

https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-001336-10/DE

University Medical Centre Hamburg-Eppendorf - Stefan Kluge

s.kluge@uke.de

2021-12-30

Recruiting

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

Hospitalization for moderate to severe COVID-19, defined as fulfilling at a minimum the following clinical status category on the WHO 8-point ordinal scale (corresponds to RKI score “severe” and “critical”): (i) “score 4” [oxygen via mask or nasal] Bio-ADM ≥50 pg/mL or ≥30% increase until the end of the next day (with a minimum of 35 pg/mL at all) DPP3 ≤ 50 ng/mL Age above 18 years at time of screening Body weight below 150 kg at time of screening

Life expectancy less than 3 months before COVID-19 at the discretion of the investigator Invasive mechanical ventilation ≥72 hours at time-point of randomization History of severe asthma, atopic allergy, severe immune or chronic inflammatory conditions (e.g. systemic lupus erythematosus) Resuscitation > 45 minutes Hypersensitivity to the active substance, to Adrecizumab or any of its excipients, or known serious hypersensitivity to other monoclonal antibodies Currently receiving systemic chemotherapy and/or radiotherapy Pre-existing severe chronic liver disease (i.e. Child-Pugh C) before COVID-19 hospitalization Pre-existing dialysis therapy before COVID-19 hospitalization Note: RRT and/ or ECMO (initiated during COVID-19 hospitalization) are not an exclusion criteria

2

University Medical Centre Hamburg-Eppendorf

18

100

Germany

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

218

Time to clinical improvement, defined as the time from randomization to an improvement of two points (from the status at randomization) on the WHO 8-point ordinal scale or live discharge from the hospital, whichever came first.

Declared number of arm (3.0) differs from found arms (2.0)

Phase 2

[{"arm_notes": null, "treatment_id": 2098, "treatment_name": "Adrecizumab", "treatment_type": "Monoclonal antibodies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": null, "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]