Lanadelumab for Treatment of COVID-19 Disease

Phase 1

Completed

• Conditions: COVID-19
• Interventions: Other: regular care; Biological: lanadelumab

• Registration Number: NCT04422509
• Lead Sponsor: 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-06-03
• Study First Submitted QC: 2020-06-08
• Study First Posted: 2020-06-09
• Study Start: 2020-10-30
• Primary Completion: 2021-02-25
• Study Completion: 2021-04-30
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-11
• Last Update Posted: 2021-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
controls	regular care	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.
lanadelumab	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).

Primary Outcome Measures

Name	Time	Method
oxygen	2 weeks	oxygen use in L/min

Secondary Outcome Measures

Name	Time	Method
adverse events	2 weeks	adverse events after lanadelumab administration

Trial Locations

Locations (4)

Rijnstate hospital; 🇳🇱 Arnhem, Netherlands

Radboudumc; 🇳🇱 Nijmegen, Netherlands

Amsterdam UMC; 🇳🇱 Amsterdam, Netherlands

UMC Utrecht; 🇳🇱 Utrecht, Netherlands