Lanadelumab for Treatment of COVID-19 Disease | NCT04422509

Studies
Lanadelumab for Treatment of COVID-19 Disease

NCT04422509

Sponsor

Radboud University Medical Center

Status

Completed

Last Update Posted

Jul 13, 2021Actual

Enrollment

43Actual

Phase

Phase 1Phase 2

Conditions

COVID-19

Interventions

lanadelumab
regular care

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 30, 2020Actual

Primary Completion Date

Feb 25, 2021Actual

Completion Date

Apr 30, 2021Actual

First Submitted Date

Jun 3, 2020

First Submission Date that Met QC Criteria

Jun 8, 2020

First Posted Date

Jun 9, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 11, 2021

Last Update Posted Date

Jul 13, 2021Actual

Name	Class
Takeda	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

43Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
lanadelumab	Experimental	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
controls	Other	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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
lanadelumab	Biological	single dose, or two doses administered iv	lanadelumab

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
oxygen	oxygen use in L/min	2 weeks

Secondary Outcomes

Measure	Description	Time Frame
adverse events	adverse events after lanadelumab administration	2 weeks

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Amsterdam UMC		Amsterdam			Netherlands
Rijnstate hospital

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

this has not yet been decided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000086382	COVID-19

Ancestor Terms

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C000596550	lanadelumab

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided