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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. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT04422509
Recruitment Status : Completed
First Posted : June 9, 2020
Last Update Posted : July 13, 2021
Information provided by (Responsible Party):
Radboud University Medical Center

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)
Actual Enrollment : 43 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: controls will get standard of care and 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
Actual Study Start Date : October 30, 2020
Actual Primary Completion Date : February 25, 2021
Actual Study Completion Date : April 30, 2021

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: lanadelumab
20 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

20 patients will received standard of care In additiona, for every index patient we will match one 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

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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

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

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Amsterdam UMC
Amsterdam, Netherlands
Rijnstate hospital
Arnhem, Netherlands
Nijmegen, Netherlands
UMC Utrecht
Utrecht, Netherlands
Sponsors and Collaborators
Radboud University Medical Center
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Responsible Party: Radboud University Medical Center
ClinicalTrials.gov Identifier: NCT04422509    
Other Study ID Numbers: UMCN-AKF20.04
First Posted: June 9, 2020    Key Record Dates
Last Update Posted: July 13, 2021
Last Verified: July 2021
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
Additional relevant MeSH terms:
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Respiratory Tract Infections
Pneumonia, Viral
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases