Lanadelumab for Treatment of COVID-19 Disease

COVID-19 Clinical Trial

— COVID_LAN  

Official title:

Lanadelumab for Treatment of COVID-19 Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04422509
• Other study ID #: UMCN-AKF20.04
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: October 30, 2020
• Est. completion date: April 30, 2021

Study information

• Verified date: July 2021
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: April 30, 2021
• Est. primary completion date: February 25, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19

Intervention

Biological:
• lanadelumab
single dose, or two doses administered iv

Other:
• regular care
no lanadelumab administration, treated according to regular care

Locations

Country	Name	City	State
Netherlands	Amsterdam UMC	Amsterdam
Netherlands	Rijnstate hospital	Arnhem
Netherlands	Radboudumc	Nijmegen
Netherlands	UMC Utrecht	Utrecht

Sponsors (2)

Lead Sponsor	Collaborator
Radboud University	Takeda

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	oxygen	oxygen use in L/min	2 weeks
Secondary	adverse events	adverse events after lanadelumab administration	2 weeks