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OpenTrials
Completed

NCT Number: NCT04422509

Lanadelumab for Treatment of COVID-19 Disease

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.

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Amsterdam UMC, Amsterdam, Netherlands

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

lanadelumab

Biological

single dose, or two doses administered iv

Regular Care

Other

no lanadelumab administration, treated according to regular care

Primary outcomes

  1. oxygen

    Time frame: 2 weeks

    oxygen use in L/min

Secondary outcomes

  1. adverse events

    Time frame: 2 weeks

    adverse events after lanadelumab administration

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Collaborators

  • Takeda

Registry information

Acronym: COVID_LAN

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 9, 2020
Registry last updated
Jul 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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