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Trial - NCT05156671


Column Value
Trial registration number NCT05156671
Full text link
Last imported at : Dec. 16, 2021, 2 a.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT05156671

First author
Last imported at : Dec. 16, 2021, 2 a.m.
Source : ClinicalTrials.gov

Mahir Karakas, MD, MBA

Contact
Last imported at : Dec. 16, 2021, 2 a.m.
Source : ClinicalTrials.gov

m.karakas@uke.de

Registration date
Last imported at : Dec. 16, 2021, 2 a.m.
Source : ClinicalTrials.gov

2021-12-14

Recruitment status
Last imported at : Oct. 17, 2022, 12:34 p.m.
Source : ClinicalTrials.gov

Recruiting

Study design
Last imported at : Dec. 16, 2021, 2 a.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Dec. 16, 2021, 2 a.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Dec. 16, 2021, 2 a.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : Dec. 16, 2021, 2 a.m.
Source : ClinicalTrials.gov

Blind label

Center
Last imported at : Dec. 16, 2021, 2 a.m.
Source : ClinicalTrials.gov

multi-center

Study aim
Last imported at : Dec. 16, 2021, 2 a.m.
Source : ClinicalTrials.gov

Treatment

Inclusion criteria
Last imported at : July 19, 2023, noon
Source : ClinicalTrials.gov

inclusion criteria: hospitalization with moderate to severe covid-19, defined as fulfilling at a minimum the following clinical status category on the who 8-point ordinal scale: (i) "score 4" [oxygen via mask or nasal] laboratory-confirmed sars-cov-2 infection at index hospitalisation as determined by pcr or other validated commercial or public health assay 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 ≤30 ng/ml age ≥18 years at time of screening body weight ≤ 150 kg at time of screening

Exclusion criteria
Last imported at : July 19, 2023, noon
Source : ClinicalTrials.gov

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 resuscitation > 45 minutes hypersensitivity to the active substance, to adrecizumab or any of its excipients, or known serious hypersensitivity to other monoclonal antibodies uncontrolled haematological/ oncological malignancies pre-existing severe chronic liver disease (i.e. child-pugh c) before covid-19 hospitalization absolute neutropenia <500 per μl

Number of arms
Last imported at : Dec. 16, 2021, 2 a.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : Dec. 16, 2021, 2 a.m.
Source : ClinicalTrials.gov

Universitätsklinikum Hamburg-Eppendorf

Inclusion age min
Last imported at : Dec. 16, 2021, 2 a.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : Dec. 16, 2021, 2 a.m.
Source : ClinicalTrials.gov

100

Countries
Last imported at : Oct. 17, 2022, 12:34 p.m.
Source : ClinicalTrials.gov

Germany

Type of patients
Last imported at : Dec. 16, 2021, 2 a.m.
Source : ClinicalTrials.gov

Moderate/severe disease at enrollment

Severity scale
Last imported at : Dec. 16, 2021, 2 a.m.
Source : ClinicalTrials.gov

4: Moderate/severe disease at enrollment

Total sample size
Last imported at : July 2, 2022, 11:30 p.m.
Source : ClinicalTrials.gov

180

primary outcome
Last imported at : Dec. 16, 2021, 2 a.m.
Source : ClinicalTrials.gov

Time to clinical improvement

Notes
Last imported at : Dec. 16, 2021, 2 a.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : March 18, 2022, 1 a.m.
Source : ClinicalTrials.gov

Phase 2

Arms
Last imported at : Dec. 16, 2021, 2 a.m.
Source : ClinicalTrials.gov

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