Lanadelumab for Treatment of COVID-19 Disease (COVID_LAN)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04422509|
Recruitment Status : Not yet recruiting
First Posted : June 9, 2020
Last Update Posted : June 9, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|COVID-19||Biological: lanadelumab Other: regular care||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Sequential Assignment|
|Intervention Model Description:||historical controls will be matched to the patients included|
|Masking:||None (Open Label)|
|Official Title:||Lanadelumab for Treatment of COVID-19 Disease|
|Estimated Study Start Date :||June 25, 2020|
|Estimated Primary Completion Date :||June 1, 2021|
|Estimated Study Completion Date :||August 1, 2021|
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).
single dose, or two doses administered iv
For every index patient we will match three historical controls. Controls will be matched based on age, bodyweight and gender.
Other: regular care
no lanadelumab administration, treated according to regular care
- oxygen [ Time Frame: 2 weeks ]oxygen use in L/min
- adverse events [ Time Frame: 2 weeks ]adverse events after lanadelumab administration
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04422509
|Contact: Roger Bruggemannfirstname.lastname@example.org|
|Contact: Frank van de Veerdonk|
|Jereoen Bosch hospital|
|Contact: van der Linden|
|Contact: van het Veer|
|Den Haag, Netherlands|
|Contact: van de Veerdonk|