Lanadelumab for Treatment of COVID-19 Disease

NCT04422509 | Completed Phase 1

• 1 other identifier: UMCN-AKF20.04
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 4

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.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• oxygen

  oxygen use in L/min

  2 weeks

Secondary Outcomes (1)

• adverse events

  2 weeks

Study Arms (2)

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

lanadelumab BIOLOGICAL

single dose, or two doses administered iv

lanadelumab

regular care OTHER

no lanadelumab administration, treated according to regular care

controls

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Radboud University Medical Center: lead
• Takeda: collaborator

Study Sites (4)

Amsterdam UMC

Amsterdam, Netherlands

Location

Rijnstate hospital

Arnhem, Netherlands

Location

Radboudumc

Nijmegen, Netherlands

Location

UMC Utrecht

Utrecht, Netherlands

Location

MeSH Terms

Conditions

COVID-19

Interventions

lanadelumab

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: controls will get standard of care and historical controls will be matched to the patients included

Study Record Dates

• First Submitted: June 3, 2020
• First Posted: June 9, 2020
• Study Start: October 30, 2020
• Primary Completion: February 25, 2021
• Study Completion: April 30, 2021
• Last Updated: July 13, 2021

Record last verified: 2021-07

Locations

NL (4)