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Lanadelumab for Treatment of COVID-19 Disease (COVID_LAN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04422509
Recruitment Status : Not yet recruiting
First Posted : June 9, 2020
Last Update Posted : June 9, 2020
Sponsor:
Collaborator:
Takeda
Information provided by (Responsible Party):
Radboud University

Brief Summary:

So far little is very few drugs have demonstrated positive results for treatment of COVID19.

Recently the researchers have shown that the use of icatibant in COVID-19 results in a potent decrease in oxygen use. Yet the effect of the three dosages as according to the label dose was insufficient to maintain the clinical improvement in a small group of patients. The researchers argue that with the use of lanadelumab a more lasting effect can be reached due to its longer half life.


Condition or disease Intervention/treatment Phase
COVID-19 Biological: lanadelumab Other: regular care Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: historical controls will be matched to the patients included
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Lanadelumab for Treatment of COVID-19 Disease
Estimated Study Start Date : June 25, 2020
Estimated Primary Completion Date : June 1, 2021
Estimated Study Completion Date : August 1, 2021

Arm Intervention/treatment
Experimental: lanadelumab
Patients will receive an intravenous dose of 300 mg lanadelumab on day 1, followed by a second dose of lanadelumab 300mg iv on day 4 (if needed).
Biological: lanadelumab
single dose, or two doses administered iv

historical controls
For every index patient we will match three historical controls. Controls will be matched based on age, bodyweight and gender.
Other: regular care
no lanadelumab administration, treated according to regular care




Primary Outcome Measures :
  1. oxygen [ Time Frame: 2 weeks ]
    oxygen use in L/min


Secondary Outcome Measures :
  1. adverse events [ Time Frame: 2 weeks ]
    adverse events after lanadelumab administration



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient is SARS-COV2 positive (PCR)
  • Without oxygen a saturation below 90%
  • At least 3L/min oxygen dependent
  • Patient is 16 years and older

Exclusion Criteria:

  • Has previously participated in this study
  • Acute myocardial or cerebral ischemic event at time of enrolment
  • Receiving ACE or ARB inhibitor or comparable drugs 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
  • A baseline alanine aminotransferase or an aspartate aminotransferase that is more than five times the upper limit of normal
  • Patient is known hypersensitive to full human monoclonal antibodies
  • Patient is pregnant or breast feeding

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04422509


Contacts
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Contact: Roger Bruggemann 0031243611111 roger.bruggemann@radboudumc.nl
Contact: Frank van de Veerdonk

Locations
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Netherlands
Jereoen Bosch hospital
's-Hertogenbosch, Netherlands
Contact: Derijks         
Amsterdam UMC
Amsterdam, Netherlands
Contact: Wiersinga         
Rijnstate hospital
Arnhem, Netherlands
Contact: Hassing         
Tergooi ziekenhuizen
Blaricum, Netherlands
Contact: van der Linden         
Amphia hospital
Breda, Netherlands
Contact: van het Veer         
Haga hospital
Den Haag, Netherlands
Contact: Wilms         
Radboudumc
Nijmegen, Netherlands
Contact: van de Veerdonk         
Elisabeth-Tweesteden ziekenhuis
Tilburg, Netherlands
Contact: Berrevoorts         
UMC Utrecht
Utrecht, Netherlands
Contact: Leavis         
Isala klinieken
Zwolle, Netherlands
Contact: Smolders         
Sponsors and Collaborators
Radboud University
Takeda
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Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT04422509    
Other Study ID Numbers: UMCN-AKF20.04
First Posted: June 9, 2020    Key Record Dates
Last Update Posted: June 9, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: this has not yet been decided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No