COVID-19
Conditions
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.
Interventions
single dose, or two doses administered iv
no lanadelumab administration, treated according to regular care
Sponsors
Study design
Intervention model description
controls will get standard of care and historical controls will be matched to the patients included
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| oxygen | 2 weeks | oxygen use in L/min |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| adverse events | 2 weeks | adverse events after lanadelumab administration |
Countries
Netherlands