anadelumab for treatment of COVID-19 disease

Phase 1

• Conditions: COVID-19; MedDRA version: 23.0Level: PTClassification code 10084268Term: COVID-19System Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-002472-12-NL
• Lead Sponsor: Radboud University Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-05-14
• Last Update Posted: 17 May 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 80

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified