Lanadelumab for treatment of COVID-19 disease

Lanadelumab for treatment of COVID-19 disease - COVID-LAN

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-002472-12-NL

Enrollment

Registered

2020-05-14

Start date

2020-06-11

Completion date

Unknown

Last updated

2021-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19 MedDRA version: 23.0 Level: PT Classification code 10084268 Term: COVID-19 System Organ Class: 10021881 - Infections and infestations

Interventions

Trade Name: TAKHZYRO Pharmaceutical Form: Solution for injection INN or Proposed INN: LANADELUMAB CAS Number: 1426055-14-2 Current Sponsor code: LANADELUMAB Other descriptive name: LANADELUMAB Concent

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patient is SARS-COV2 positive (PCR) 2. Without oxygen a saturation below 90% and/or at least 3L/min oxygen dependent 3. Patient is 16 years and older Are the trial subjects under 18? yes Number of subjects for this age range: 3 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 37

Exclusion criteria

Exclusion criteria: 1. Has previously participated in this study 2. Acute myocardial or cerebral ischemic event at time of enrolment 3. Receiving an agent that is specified as an intervention in this domain as a usual medication prior to this hospitalization will exclude a patient from receiving that agent 4. A baseline alanine aminotransferase or an aspartate aminotransferase that is more than five times the upper limit of normal will result in exclusion from receiving lanadelumab 5. Patient is known hypersensitive to full human monoclonal antibodies. 6. Patient is pregnant or breast feeding

Design outcomes

Primary

Measure	Time frame
Main Objective: To generate the proof of concept for lanadelumab for treatment of symptoms of COVID-19 disease;Secondary Objective: To demonstrate its safety after intravenous administration;Primary end point(s): Reduction in oxygen need;Timepoint(s) of evaluation of this end point: Oxygen need is recorded during the entire admission period of the patient.	—

Secondary

Measure	Time frame
Secondary end point(s): adverse events;Timepoint(s) of evaluation of this end point: Safety assessment during the entire hospital admission. Evaluation at the end of the trial.	—

Countries

Netherlands

Contacts

Public ContactRoger Bruggemann

Radboud University Medical Center

roger.bruggemann@radboudumc.nl+31243617744

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026