Back to resultsLanadelumab for Treatment of COVID-19 Disease (COVID_LAN)
Primary Purpose
COVID-19
Status
Completed
Phase
Phase 1
Locations
Netherlands
Study Type
Interventional
Intervention
lanadelumab
regular care
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19
Eligibility 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
Sites / Locations
- Amsterdam UMC
- Rijnstate hospital
- Radboudumc
- UMC Utrecht
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
lanadelumab
controls
Arm Description
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).
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.
Outcomes
Primary Outcome Measures
oxygen
oxygen use in L/min
Secondary Outcome Measures
adverse events
adverse events after lanadelumab administration
Full Information
NCT ID
NCT04422509
First Posted
June 3, 2020
Last Updated
July 11, 2021
Sponsor
Radboud University Medical Center
Collaborators
Takeda
1. Study Identification
Unique Protocol Identification Number
NCT04422509
Brief Title
Lanadelumab for Treatment of COVID-19 Disease
Acronym
COVID_LAN
Official Title
Lanadelumab for Treatment of COVID-19 Disease
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
October 30, 2020 (Actual)
Primary Completion Date
February 25, 2021 (Actual)
Study Completion Date
April 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Radboud University Medical Center
Collaborators
Takeda
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Model Description
controls will get standard of care and historical controls will be matched to the patients included
Masking
None (Open Label)
Allocation
Randomized
Enrollment
43 (Actual)
8. Arms, Groups, and Interventions
Arm Title
lanadelumab
Arm Type
Experimental
Arm Description
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).
Arm Title
controls
Arm Type
Other
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
lanadelumab
Intervention Description
single dose, or two doses administered iv
Intervention Type
Other
Intervention Name(s)
regular care
Intervention Description
no lanadelumab administration, treated according to regular care
Primary Outcome Measure Information:
Title
oxygen
Description
oxygen use in L/min
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
adverse events
Description
adverse events after lanadelumab administration
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Amsterdam UMC
City
Amsterdam
Country
Netherlands
Facility Name
Rijnstate hospital
City
Arnhem
Country
Netherlands
Facility Name
Radboudumc
City
Nijmegen
Country
Netherlands
Facility Name
UMC Utrecht
City
Utrecht
Country
Netherlands
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
this has not yet been decided
Learn more about this trial
Lanadelumab for Treatment of COVID-19 Disease
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